6,511 Senior Quality Assurance Manager Manufacturing Remote jobs in Kenya
Pharmaceutical Quality Assurance Manager (Remote)
Posted 14 days ago
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Job Description
Our client, a leading pharmaceutical company, is actively seeking a meticulous and experienced Pharmaceutical Quality Assurance Manager to ensure compliance with stringent regulatory standards. This role is fully remote, providing a unique opportunity to contribute to global health initiatives from your home office. You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS) to meet international regulatory requirements (e.g., GMP, ICH, FDA). Key responsibilities include overseeing internal and external audits, managing deviations and CAPAs (Corrective and Preventive Actions), reviewing batch records, and ensuring the quality of all pharmaceutical products throughout their lifecycle. The ideal candidate will possess a strong understanding of pharmaceutical manufacturing processes, quality control principles, and regulatory affairs. Excellent analytical skills, meticulous attention to detail, and exceptional written and verbal communication abilities are crucial. You will lead and mentor a team of QA professionals, fostering a culture of quality and continuous improvement. This position requires a proactive approach to identifying and mitigating quality risks. Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, is essential. The successful applicant will demonstrate leadership in quality assurance strategy and execution. Experience with validation processes, change control, and supplier quality management is vital. This is an exceptional opportunity to make a significant impact on patient safety and product quality within a dynamic and growing pharmaceutical organization. We are looking for a dedicated professional who is passionate about upholding the highest standards of quality in the pharmaceutical industry. The role involves staying current with evolving regulatory landscapes and implementing best practices. A deep understanding of pharmacovigilance and product complaint handling is also required. This is a critical role that demands integrity, expertise, and a commitment to excellence in pharmaceutical quality.
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Principal Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
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Job Description
Our client, a leading innovator in the pharmaceutical industry, is looking for a Principal Pharmaceutical Quality Assurance Manager to join their globally distributed team. This is a critical, fully remote role, empowering you to contribute to life-saving medications from the comfort of your home office. You will be responsible for establishing, maintaining, and improving the overall quality management system (QMS) across all pharmaceutical development and manufacturing processes. This includes ensuring strict adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant international regulatory standards such as FDA, EMA, and WHO guidelines. Your responsibilities will encompass developing and executing comprehensive quality control strategies, performing risk assessments, and managing deviations, CAPAs (Corrective and Preventive Actions), and change controls. You will lead and mentor quality assurance teams, fostering a culture of quality excellence and continuous improvement. Conducting internal and external audits, supplier qualification, and ensuring the integrity of all drug product documentation are integral to this position. You will also play a key role in regulatory submissions and inspections, serving as a subject matter expert on quality matters. The ideal candidate possesses a deep understanding of pharmaceutical sciences, analytical methodologies, and regulatory affairs, coupled with exceptional leadership and problem-solving abilities. Your strategic vision will guide the company's commitment to delivering safe, effective, and high-quality pharmaceutical products to patients worldwide. This remote position demands a proactive approach, strong organizational skills, and the ability to collaborate effectively with cross-functional teams across different time zones. You will be at the forefront of ensuring the highest standards of quality in a rapidly evolving pharmaceutical landscape, driving innovation and patient safety through rigorous QA oversight.
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Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
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Job Description
Our client, a growing pharmaceutical company, is seeking a highly motivated and experienced Lead Pharmaceutical Quality Assurance Manager to oversee their quality systems from a fully remote position. This role is critical to ensuring compliance with stringent regulatory standards (e.g., GMP, ICH) and maintaining the integrity of pharmaceutical products. The ideal candidate will have a comprehensive understanding of quality assurance principles within the pharmaceutical industry, coupled with strong leadership and project management skills. You will be responsible for developing, implementing, and maintaining the Quality Management System (QMS), including SOPs, change control, deviation management, CAPA, and validation processes. The role involves leading and mentoring a team of QA professionals, conducting internal audits, and supporting external regulatory inspections. You will play a key part in product lifecycle management, ensuring quality is embedded at every stage. Collaboration with R&D, manufacturing, and regulatory affairs departments is essential to ensure consistent product quality and timely submissions. The successful applicant will be adept at risk assessment and management, with a keen eye for detail and a commitment to continuous improvement. Experience with electronic QMS (eQMS) and data integrity initiatives is highly desirable. This position requires a proactive individual who can manage multiple priorities effectively and thrive in an independent remote work environment. You will be instrumental in shaping the company's quality culture and ensuring adherence to the highest standards of pharmaceutical manufacturing. The ability to interpret regulatory guidelines and translate them into practical, actionable quality procedures is paramount. This is an excellent opportunity for a seasoned QA professional to take on a leadership role with significant responsibility and influence in a dynamic sector. The candidate will be expected to contribute to strategic quality initiatives and ensure the overall compliance of the organization with global pharmaceutical regulations. The role demands a thorough understanding of quality metrics and the ability to drive data-driven decisions for quality improvement.
Responsibilities:
Responsibilities:
- Lead the development, implementation, and maintenance of the Pharmaceutical Quality Management System (QMS).
- Ensure compliance with Good Manufacturing Practices (GMP) and relevant international regulatory standards (e.g., ICH).
- Oversee SOP development, implementation, and training.
- Manage change control, deviation, and CAPA (Corrective and Preventive Actions) systems.
- Conduct internal audits and support external regulatory inspections.
- Review and approve validation master plans, protocols, and reports.
- Assess and manage quality-related risks throughout the product lifecycle.
- Mentor and guide a team of Quality Assurance professionals.
- Collaborate with R&D, manufacturing, and regulatory affairs to ensure quality standards are met.
- Promote a culture of quality and continuous improvement within the organization.
- Ensure data integrity across all quality-related systems and processes.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Master's degree is a plus.
- Minimum of 7 years of experience in Pharmaceutical Quality Assurance, with at least 2 years in a lead or managerial role.
- In-depth knowledge of GMP regulations and quality system principles.
- Experience with QMS software, validation, audits, and regulatory submissions.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent leadership, communication, and interpersonal skills.
- Proven ability to manage multiple projects and priorities in a remote setting.
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Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to lead and enhance their quality systems from a fully remote setting. This critical role ensures that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory requirements such as GMP (Good Manufacturing Practices). The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory compliance. You will be responsible for developing, implementing, and maintaining comprehensive quality assurance programs, including SOPs (Standard Operating Procedures), quality audits, risk management, and deviation investigations. This role involves close collaboration with manufacturing, R&D, regulatory affairs, and other departments to ensure consistent quality throughout the product lifecycle. The Senior Manager will also lead quality improvement initiatives, drive CAPA (Corrective and Preventive Actions), and manage regulatory inspections. As this is a fully remote position, exceptional communication skills, strong leadership capabilities, and the ability to foster a culture of quality remotely are essential. You will be instrumental in ensuring the integrity of our client's pharmaceutical products and maintaining compliance with global health authority standards. This is a significant opportunity for a dedicated QA professional to make a substantial impact within a dynamic and forward-thinking pharmaceutical organization, offering the flexibility of remote work. The Mombasa, Mombasa, KE location is conceptually relevant to this remote role.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and maintain robust pharmaceutical quality assurance systems and programs.
- Ensure compliance with cGMP, ICH guidelines, and other relevant regulatory standards.
- Oversee quality control procedures, including batch record review and release.
- Lead internal and external quality audits, and manage regulatory inspections.
- Investigate deviations, implement CAPA, and manage change control processes.
- Conduct risk assessments and develop mitigation strategies for quality-related issues.
- Collaborate with manufacturing, R&D, and regulatory affairs to resolve quality issues.
- Train and mentor QA personnel and other staff on quality systems and compliance.
- Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency.
- Prepare quality reports and present findings to senior management and regulatory bodies.
Qualifications:
- Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance and Quality Control.
- In-depth knowledge of cGMP regulations, pharmaceutical manufacturing processes, and quality systems.
- Proven experience in managing quality audits, regulatory inspections, and CAPA systems.
- Strong understanding of pharmaceutical product development and lifecycle management.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills, vital for remote management.
- Ability to manage multiple projects and prioritize effectively in a dynamic environment.
- Experience with validation processes (process, equipment, cleaning) is highly desirable.
- Familiarity with pharmacopeial standards (USP, EP, JP).
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Senior Pharmaceutical Quality Assurance Manager - Remote Oversight
Posted 13 days ago
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Job Description
Our client is looking for a meticulous and experienced Senior Pharmaceutical Quality Assurance Manager to oversee their quality systems and compliance initiatives remotely. This is a vital, fully remote role responsible for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. You will develop, implement, and maintain robust Quality Management Systems (QMS) in accordance with global regulatory requirements (e.g., GMP, ICH guidelines). Key responsibilities include conducting internal audits, managing external audits, investigating deviations and CAPAs (Corrective and Preventive Actions), and ensuring all documentation is accurate and up-to-date. You will lead a remote QA team, providing guidance on quality control processes, regulatory compliance, and continuous improvement efforts. The ideal candidate will have a strong background in pharmaceutical manufacturing, quality control, and regulatory affairs. Experience with validation processes, change control, and risk management is essential. You will be responsible for reviewing and approving critical quality documents, such as batch records, validation protocols, and SOPs. Excellent analytical, problem-solving, and communication skills are required, along with the ability to effectively manage and motivate a remote team. This role requires a proactive approach to quality assurance, identifying potential issues before they arise and implementing effective solutions. If you are a dedicated QA professional with a passion for ensuring product integrity and possess the skills to lead a remote team in a highly regulated industry, this is an outstanding opportunity to contribute to the development and manufacturing of life-saving pharmaceuticals. Your expertise will be crucial in upholding the integrity of our client's product pipeline and ensuring patient safety.
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Senior Pharmaceutical Quality Assurance Manager - Remote Compliance
Posted 22 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to ensure regulatory compliance and uphold the highest quality standards across their operations. This position is fully remote, allowing you to manage quality systems and compliance from your home office. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) in accordance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
Key responsibilities include overseeing the quality assurance and quality control functions, ensuring product integrity and patient safety. You will lead internal and external audits, manage deviations, change controls, and CAPA systems. This role involves developing and delivering quality training programs to staff and ensuring adherence to established SOPs. You will also be responsible for reviewing and approving batch records, validation protocols, and other critical quality documents. Staying current with evolving global pharmaceutical regulations and ensuring the company remains compliant will be a core function. Collaboration with R&D, manufacturing, and regulatory affairs departments to address quality issues and implement corrective actions is essential.
Candidates must possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred. A minimum of 8-10 years of progressive experience in Quality Assurance/Quality Control within the pharmaceutical industry is required. Demonstrated experience in developing and implementing QMS, leading audits, and managing regulatory inspections is essential. Strong knowledge of GMP, GLP, GDP, and relevant international regulatory guidelines (e.g., FDA, EMA) is a must. Excellent analytical, problem-solving, and decision-making skills are expected. Outstanding communication, leadership, and interpersonal skills are necessary for managing teams remotely and interacting effectively with regulatory bodies and internal stakeholders. The ability to interpret complex regulatory requirements and translate them into actionable quality procedures is crucial.
This is an exceptional opportunity for a seasoned quality professional to drive compliance and ensure excellence in pharmaceutical manufacturing remotely, supporting the company's operations and market presence, including in **Machakos, Machakos, KE**.
Key responsibilities include overseeing the quality assurance and quality control functions, ensuring product integrity and patient safety. You will lead internal and external audits, manage deviations, change controls, and CAPA systems. This role involves developing and delivering quality training programs to staff and ensuring adherence to established SOPs. You will also be responsible for reviewing and approving batch records, validation protocols, and other critical quality documents. Staying current with evolving global pharmaceutical regulations and ensuring the company remains compliant will be a core function. Collaboration with R&D, manufacturing, and regulatory affairs departments to address quality issues and implement corrective actions is essential.
Candidates must possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred. A minimum of 8-10 years of progressive experience in Quality Assurance/Quality Control within the pharmaceutical industry is required. Demonstrated experience in developing and implementing QMS, leading audits, and managing regulatory inspections is essential. Strong knowledge of GMP, GLP, GDP, and relevant international regulatory guidelines (e.g., FDA, EMA) is a must. Excellent analytical, problem-solving, and decision-making skills are expected. Outstanding communication, leadership, and interpersonal skills are necessary for managing teams remotely and interacting effectively with regulatory bodies and internal stakeholders. The ability to interpret complex regulatory requirements and translate them into actionable quality procedures is crucial.
This is an exceptional opportunity for a seasoned quality professional to drive compliance and ensure excellence in pharmaceutical manufacturing remotely, supporting the company's operations and market presence, including in **Machakos, Machakos, KE**.
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Senior Pharmaceutical Quality Assurance Manager - Remote Compliance Lead
Posted 12 days ago
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Job Description
Our client is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to lead their remote compliance efforts. This crucial role demands a deep understanding of pharmaceutical manufacturing, regulatory affairs, and quality management systems. You will be responsible for ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements, operating entirely remotely.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in compliance with global pharmaceutical regulations (e.g., GMP, ICH).
- Oversee and manage all aspects of pharmaceutical quality assurance, including batch record review, deviation management, CAPA, and change control.
- Conduct internal audits and support external regulatory inspections (e.g., FDA, EMA).
- Ensure the quality and integrity of raw materials, in-process materials, and finished products.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality throughout the lifecycle.
- Manage vendor quality assessments and ensure supplier compliance.
- Develop and deliver training programs on GMP and quality standards for relevant personnel.
- Investigate product quality complaints and implement corrective and preventive actions.
- Stay abreast of evolving regulatory landscapes and industry best practices.
- Lead and mentor a remote quality assurance team, fostering a culture of quality excellence.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. A Master's degree or PhD is a plus.
- Minimum of 8 years of experience in the pharmaceutical industry, with at least 5 years in Quality Assurance/Quality Control roles.
- Extensive knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
- Proven experience in managing QMS, conducting audits, and handling regulatory inspections.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent communication, leadership, and interpersonal skills, with the ability to effectively manage remote teams.
- Experience with pharmaceutical manufacturing processes and technologies.
- Familiarity with data integrity principles and electronic record-keeping systems.
- Ability to interpret and apply complex regulatory requirements.
- Relevant professional certifications (e.g., ASQ Certified Quality Auditor/Manager) are highly desirable.
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Senior Pharmaceutical Quality Assurance Manager - Remote Compliance Expert
Posted 7 days ago
Job Viewed
Job Description
Our client, a rapidly growing pharmaceutical company dedicated to improving global health, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager for a fully remote position. This critical role will ensure adherence to the highest standards of quality and regulatory compliance across all pharmaceutical operations. You will be instrumental in developing, implementing, and maintaining robust Quality Management Systems (QMS), overseeing audits, and driving continuous improvement initiatives. This is a remote-first role, allowing you to contribute to pharmaceutical excellence from your home office.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with GMP, ICH, and other relevant regulatory guidelines.
- Oversee and manage all aspects of pharmaceutical quality assurance, including batch record review, deviation investigations, and CAPA management.
- Plan, conduct, and coordinate internal and external audits (vendor qualification, regulatory inspections).
- Ensure compliance with all applicable national and international pharmaceutical regulations.
- Develop and deliver training programs on quality assurance principles and regulatory requirements.
- Lead and manage quality risk assessments and implement mitigation strategies.
- Review and approve validation protocols and reports for equipment, processes, and analytical methods.
- Contribute to the development and implementation of new pharmaceutical products, ensuring quality by design.
- Maintain accurate and up-to-date quality documentation and records.
- Collaborate effectively with R&D, manufacturing, regulatory affairs, and other departments in a remote setting.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 8 years of progressive experience in pharmaceutical quality assurance and regulatory compliance.
- In-depth knowledge of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., FDA, EMA, WHO).
- Proven experience in developing and implementing QMS, conducting audits, and managing deviations/CAPAs.
- Strong understanding of pharmaceutical product development, manufacturing processes, and analytical testing.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex quality concepts.
- Demonstrated ability to work independently, manage multiple priorities, and lead effectively in a remote environment.
- Experience with electronic QMS is a plus.
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Remote Quality Assurance Manager (Manufacturing)
Posted 16 days ago
Job Viewed
Job Description
Our client, a prominent manufacturing firm, is seeking an experienced and detail-oriented Remote Quality Assurance Manager to uphold and enhance product quality standards. This fully remote role requires a proactive approach to developing and implementing comprehensive quality management systems. The QA Manager will be responsible for establishing quality control procedures, monitoring production processes, and conducting rigorous inspections to ensure all products meet stringent specifications and regulatory requirements. You will lead root cause analysis for quality deviations, implement corrective and preventive actions, and drive continuous improvement initiatives across the manufacturing operations. The ideal candidate possesses a strong understanding of quality management principles (e.g., ISO 9001), statistical process control, and various quality testing methodologies. Excellent analytical, problem-solving, and communication skills are essential for collaborating effectively with production, engineering, and R&D teams remotely. You will be adept at using quality management software and data analysis tools to track quality metrics and report on performance. Responsibilities include: developing and implementing quality assurance strategies, establishing quality control protocols, overseeing product testing and inspection, leading root cause analysis and corrective action implementation, managing quality documentation and records, conducting internal audits, training staff on quality procedures, and ensuring compliance with industry standards and regulations. A strong commitment to maintaining product integrity and customer satisfaction is paramount. This is an excellent opportunity for a dedicated QA professional to lead quality initiatives remotely.
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Remote Quality Control & Assurance Manager (Manufacturing)
Posted 22 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Remote Quality Control and Assurance Manager to oversee the quality standards of their manufacturing operations. This is a fully remote position where you will be responsible for developing, implementing, and monitoring quality management systems and processes. You will work closely with on-site production teams, providing remote guidance, analyzing quality data, and ensuring products consistently meet high standards and customer expectations. Your expertise will be critical in driving a culture of quality throughout the organization.
Key Responsibilities:
Key Responsibilities:
- Develop and implement robust quality control (QC) and quality assurance (QA) strategies and procedures for manufacturing processes.
- Establish and monitor key performance indicators (KPIs) for quality, tracking metrics such as defect rates, customer complaints, and process variations.
- Conduct remote analysis of production data, inspection reports, and non-conformance reports to identify root causes of quality issues.
- Provide remote guidance and support to on-site QC teams, operators, and production managers on quality standards and best practices.
- Oversee the development and maintenance of quality documentation, including SOPs, work instructions, and quality manuals.
- Coordinate virtual internal audits and support external audits to ensure compliance with relevant standards (e.g., ISO 9001).
- Implement corrective and preventive actions (CAPA) and monitor their effectiveness.
- Champion a quality-first mindset across the organization through virtual communication and training initiatives.
- Stay informed about industry best practices, new quality tools, and regulatory requirements.
- Collaborate with R&D, engineering, and production teams to ensure product quality throughout the lifecycle.
- Analyze customer feedback and complaints to identify areas for improvement and drive product quality enhancements.
- Manage supplier quality expectations and processes remotely.
- Bachelor's degree in Engineering, Science, or a related technical field. A Master's degree is a plus.
- Minimum of 7 years of experience in quality control and assurance, with a significant portion in manufacturing environments.
- Proven experience in developing and implementing ISO 9001 or similar quality management systems.
- Strong understanding of statistical process control (SPC), Six Sigma, and Lean Manufacturing principles.
- Excellent analytical and problem-solving skills, with a data-driven approach to decision-making.
- Exceptional remote communication, leadership, and interpersonal skills.
- Proficiency in quality management software and data analysis tools.
- Ability to interpret technical specifications and quality standards.
- Demonstrated experience in leading and motivating teams remotely.
- Strong organizational skills and the ability to manage multiple projects and priorities effectively from a distance.
- Experience in conducting remote audits and virtual training sessions is highly valued.
- A commitment to continuous improvement and operational excellence.
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