6,560 Senior Pharmaceutical Quality Assurance Manager 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 is seeking a highly accomplished and experienced Principal Pharmaceutical Quality Assurance Manager to lead their global quality operations from a remote setting. This critical role demands extensive expertise in pharmaceutical quality systems, regulatory compliance, and strategic leadership. You will be responsible for ensuring the highest standards of quality and compliance across all pharmaceutical manufacturing and development activities. This is a fully remote position, offering the flexibility to work from anywhere. The ideal candidate will have a proven track record of successfully implementing and managing robust quality assurance programs in a GxP environment.
Responsibilities:
Qualifications:
This is a remote position, with the original operational focus being **Eldoret, Uasin Gishu, KE**. We are seeking a world-class quality leader to uphold our client's commitment to excellence in pharmaceutical manufacturing.
Responsibilities:
- Develop, implement, and maintain comprehensive pharmaceutical quality management systems (QMS) in compliance with global regulatory requirements (e.g., FDA, EMA, WHO).
- Lead and manage QA operations, including batch record review, deviation management, CAPA, change control, and internal/external audits.
- Provide strategic direction and leadership to the QA team, fostering a culture of quality and continuous improvement.
- Oversee the qualification and validation of manufacturing processes, equipment, and analytical methods.
- Ensure compliance with cGMP, ICH guidelines, and other relevant regulatory standards.
- Act as a primary contact for regulatory agencies during inspections and inquiries.
- Review and approve key quality-related documents, including SOPs, validation protocols, and reports.
- Conduct risk assessments and implement mitigation strategies to ensure product quality and patient safety.
- Stay current with evolving regulatory landscapes and implement necessary updates to quality systems.
- Mentor and develop QA personnel.
Qualifications:
- Master's or Ph.D. in Pharmacy, Chemistry, Biological Sciences, or a related field.
- Minimum of 10-12 years of progressive experience in pharmaceutical quality assurance and quality control, with at least 5 years in a management or leadership role.
- Extensive knowledge of cGMP, GxP, and regulatory requirements from major health authorities.
- Proven experience in leading successful regulatory inspections and managing complex quality systems.
- Strong understanding of pharmaceutical manufacturing processes, analytical testing, and validation principles.
- Exceptional leadership, strategic planning, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex quality issues to senior management and regulatory bodies.
- Experience managing remote QA teams and distributed operations.
- Proficiency in quality management software and electronic QMS.
This is a remote position, with the original operational focus being **Eldoret, Uasin Gishu, KE**. We are seeking a world-class quality leader to uphold our client's commitment to excellence in pharmaceutical manufacturing.
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Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
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Job Description
Our client is seeking a highly skilled and meticulous Lead Pharmaceutical Quality Assurance Manager to join their globally distributed, fully remote team. This critical role will be responsible for ensuring the highest standards of quality and compliance in all pharmaceutical processes and products. You will lead the development, implementation, and maintenance of robust quality management systems (QMS) in accordance with international regulatory guidelines (e.g., GMP, ICH). Your responsibilities will include conducting internal audits, managing external inspections, overseeing deviation investigations, and implementing corrective and preventive actions (CAPA). As a remote leader, you will excel at virtual collaboration, driving quality initiatives across different time zones, and fostering a strong quality culture within a distributed workforce. You will be instrumental in risk assessment and management, ensuring product safety and efficacy. The ideal candidate will have extensive experience in pharmaceutical quality assurance, a deep understanding of regulatory affairs, and a proven ability to lead and mentor quality professionals. Expertise in quality control testing, validation, and batch record review is essential. You will play a key role in the product lifecycle, from development to market release, ensuring all regulatory requirements are met. This is an exceptional opportunity to contribute to the development and manufacturing of life-saving medications from a remote setting. The ability to interpret and apply complex regulatory documents, troubleshoot quality issues, and drive continuous improvement is paramount. You will also be involved in supplier qualification and management. Strong analytical and problem-solving skills, coupled with excellent written and verbal communication abilities, are required. The **Meru, Meru, KE** region will be indirectly supported through the robust quality assurance framework you help establish and manage, even with the fully remote nature of this position. Your dedication to quality will directly impact patient safety.
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Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 19 days ago
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Job Description
Our client, a prominent pharmaceutical organization, is looking for a dedicated and experienced Senior Pharmaceutical Quality Assurance Manager to join their fully remote team. This critical role will ensure adherence to the highest standards of quality and regulatory compliance throughout the product lifecycle. You will be responsible for developing, implementing, and maintaining robust quality management systems, including standard operating procedures (SOPs), batch record reviews, and deviation investigations. The ideal candidate will possess a comprehensive understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines from bodies such as the FDA and EMA. Your expertise in quality risk management, change control, and CAPA (Corrective and Preventive Actions) will be essential. Key responsibilities include conducting internal audits, evaluating supplier quality, and participating in regulatory inspections. You will also play a vital role in training and mentoring QA personnel, fostering a strong quality culture within the organization. We are seeking a candidate with a Bachelor's or Master's degree in a relevant scientific field (e.g., Pharmacy, Chemistry, Biology) and a minimum of 7 years of experience in pharmaceutical quality assurance. Strong analytical, problem-solving, and decision-making skills are crucial. Excellent written and verbal communication abilities are required to effectively document findings, communicate with regulatory agencies, and collaborate with cross-functional teams. As a fully remote position, you must be highly organized, self-disciplined, and capable of working independently while maintaining proactive communication and engagement with the team. Our client is committed to patient safety and product integrity, offering a rewarding career path for QA professionals. If you are passionate about ensuring the highest quality in pharmaceutical products and thrive in a remote work environment, we invite you to apply. This role impacts quality standards for products distributed in areas like Garissa, Garissa, KE , but the position itself is entirely remote.
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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
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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 Pharmaceutical Quality Assurance Manager
Posted 20 days ago
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Job Description
Our client, a dynamic pharmaceutical company, is seeking a highly qualified and meticulous Pharmaceutical Quality Assurance Manager to lead their quality operations in a fully remote capacity. This crucial role involves ensuring adherence to stringent regulatory standards, overseeing quality control processes, and maintaining the integrity of pharmaceutical products throughout their lifecycle. You will be responsible for developing and implementing comprehensive quality management systems, conducting internal audits, and managing external regulatory inspections. Key duties include reviewing and approving batch records, managing deviations and corrective/preventive actions (CAPA), and ensuring compliance with GMP, GDP, and other relevant international guidelines. The ideal candidate possesses a strong background in pharmaceutical sciences or a related field, coupled with extensive experience in quality assurance and regulatory affairs. Proven knowledge of ICH guidelines, FDA regulations, and other global pharmaceutical standards is essential. You should be adept at risk assessment, quality risk management, and developing robust quality control strategies. This is a fully remote position, requiring exceptional attention to detail, strong leadership skills, and the ability to manage complex quality initiatives autonomously. Excellent communication and documentation skills are paramount for interacting with internal teams, external partners, and regulatory bodies virtually. The ability to maintain the highest standards of quality and compliance in a remote environment is critical. This role offers a significant opportunity to influence product quality and patient safety from anywhere, contributing to the success of a leading pharmaceutical organization. Your expertise will safeguard product integrity and regulatory compliance. This fully remote role is associated with our operations in Kakamega, Kakamega, KE , enabling focused contributions while promoting global remote collaboration.
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Lead Remote Pharmaceutical Quality Assurance Manager
Posted 11 days ago
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Job Description
Our client, a progressive pharmaceutical company, is seeking a highly experienced Lead Remote Pharmaceutical Quality Assurance Manager. This critical, fully remote role will oversee the establishment and maintenance of robust quality management systems across all operational areas. The successful candidate will be responsible for ensuring compliance with regulatory standards (e.g., GMP, GDP) and driving continuous improvement in product quality and manufacturing processes. Key responsibilities include developing, implementing, and managing quality assurance protocols, conducting internal audits, and leading external audits by regulatory bodies. You will analyze quality data, identify trends, investigate deviations and non-conformances, and implement corrective and preventive actions (CAPAs) to mitigate risks. This role requires a deep understanding of pharmaceutical manufacturing, regulatory affairs, and quality control principles. You will collaborate closely with research and development, manufacturing, and supply chain teams to embed quality into every stage of the product lifecycle. Proficiency in quality management software and analytical tools is essential. The ideal candidate will possess strong leadership skills, excellent problem-solving abilities, and exceptional communication and interpersonal skills, enabling effective collaboration and decision-making in a remote setting. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field, along with extensive experience in pharmaceutical quality assurance, is required. This is a unique opportunity to lead quality initiatives and ensure the highest standards of product safety and efficacy in a challenging and dynamic remote role, contributing significantly to our client's reputation and success. The position is nominally tied to our client's presence in Thika, Kiambu, KE , but is a completely remote position, offering significant professional autonomy and work-life balance.
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