6,786 Lead Quality Assurance Manager Manufacturing jobs in Kenya
Lead Quality Assurance Manager - Manufacturing
Posted 5 days ago
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Job Description
Our client is seeking an experienced and dedicated Lead Quality Assurance Manager to oversee their manufacturing quality initiatives. This is a fully remote position, allowing you to drive quality standards from any location. You will be responsible for developing, implementing, and maintaining comprehensive quality management systems to ensure products meet the highest standards of excellence and customer satisfaction. Your role will involve establishing quality control procedures, leading inspection processes, and analyzing quality data to identify trends and areas for improvement. You will manage a team of quality assurance professionals, providing guidance, training, and performance feedback. A strong understanding of manufacturing processes, quality control methodologies (e.g., Six Sigma, TQM), and relevant industry standards is essential. Experience with quality management software and statistical analysis tools is highly desirable. The ideal candidate will possess exceptional leadership, analytical, and problem-solving skills, with a proven track record of successfully improving quality metrics in a manufacturing setting. Strong communication and interpersonal skills are crucial for collaborating with production teams, suppliers, and senior management. This is an exciting opportunity to make a significant impact on our client's product quality and reputation, all within a flexible remote work environment. Our client is committed to delivering superior products and fostering a culture of continuous quality improvement. Your leadership will be instrumental in achieving these goals. This role has an operational context within Nakuru, Nakuru, KE , but is a fully remote position.
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Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
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Job Description
Our client is seeking an accomplished and detail-oriented Lead Pharmaceutical Quality Assurance Manager to ensure the highest standards of quality and compliance in pharmaceutical manufacturing and development. This is a critical, fully remote position for an experienced professional who can lead a virtual team and oversee all quality assurance activities. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) in adherence to global regulatory standards (e.g., GMP, FDA, EMA). The ideal candidate will have extensive experience in pharmaceutical quality control, auditing, and regulatory affairs. Your responsibilities will include conducting internal and external audits, managing deviations and CAPAs, overseeing product release, and ensuring that all pharmaceutical products meet stringent quality specifications. You will lead and mentor a team of quality assurance specialists, providing guidance and support to foster a culture of continuous improvement and compliance. This role demands exceptional analytical skills, strong problem-solving capabilities, and excellent communication and interpersonal abilities, enabling effective collaboration with diverse teams and regulatory bodies. Proficiency in quality management software and a thorough understanding of pharmaceutical manufacturing processes are essential. The successful candidate will be a self-starter, capable of managing multiple priorities and driving quality initiatives within a remote-first operational framework. This is an exceptional opportunity to shape the quality landscape of a leading pharmaceutical company and contribute to the delivery of safe and effective medicines.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in line with global regulatory standards (e.g., GMP, ISO).
- Lead and mentor a team of Quality Assurance professionals in a remote setting.
- Oversee and conduct internal and external audits of manufacturing facilities, suppliers, and processes.
- Manage deviation investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA).
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Manage product release processes to ensure products meet all quality and regulatory requirements.
- Develop and deliver quality training programs for staff.
- Act as a key point of contact for regulatory inspections and agency interactions.
- Drive continuous improvement initiatives within the QA department and across the organization.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance, with at least 2 years in a leadership role.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in auditing, CAPA management, and QMS implementation.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication, leadership, and interpersonal skills.
- Proficiency in quality management software and tools.
- Ability to manage projects and teams effectively in a remote environment.
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Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 21 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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2
Lead Remote Pharmaceutical Quality Assurance Manager
Posted 9 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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Lead Pharmaceutical Quality Assurance Manager - Regulatory Compliance
Posted 21 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is actively seeking a highly accomplished and visionary Lead Pharmaceutical Quality Assurance Manager to spearhead their quality and compliance initiatives. This is a crucial, fully remote role that will involve overseeing all aspects of quality assurance and regulatory affairs to ensure adherence to international standards and best practices. You will be responsible for developing and implementing comprehensive quality management systems that guarantee the safety, efficacy, and integrity of our client's pharmaceutical products throughout their lifecycle. The ideal candidate will have extensive experience in the pharmaceutical industry, with a proven track record in leading QA teams and navigating complex regulatory landscapes.
Key Responsibilities:
Key Responsibilities:
- Establish, maintain, and continuously improve the company's Quality Management System (QMS) in alignment with cGMP, FDA, EMA, and other relevant global regulatory requirements.
- Lead and mentor a team of Quality Assurance professionals, fostering a culture of quality excellence and continuous improvement.
- Oversee all quality-related activities, including batch record review, release processes, deviation management, CAPA implementation, and change control.
- Develop and manage validation strategies for manufacturing processes, analytical methods, and equipment.
- Conduct internal audits and host regulatory inspections, ensuring preparedness and successful outcomes.
- Collaborate closely with R&D, Manufacturing, and Regulatory Affairs departments to ensure seamless product development and commercialization.
- Monitor and analyze quality metrics, identifying trends and implementing corrective actions to mitigate risks.
- Stay current with evolving regulatory guidelines and best practices in the pharmaceutical industry and implement necessary updates to policies and procedures.
- Manage vendor qualification and audit programs to ensure the quality of supplied materials and services.
- Develop and deliver comprehensive training programs on quality and compliance topics to relevant personnel.
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Lead Production Quality Assurance Manager
Posted 12 days ago
Job Viewed
Job Description
Our client, a leading manufacturing firm, is seeking a highly skilled and experienced Lead Production Quality Assurance Manager to spearhead their quality control initiatives. This role is crucial for ensuring that all manufactured products meet the highest standards of quality, safety, and consistency. You will be responsible for developing, implementing, and overseeing comprehensive quality assurance programs across all production lines. This is a fully remote position, allowing you to manage and improve quality systems from anywhere, contributing to operational excellence on a global scale.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain robust quality management systems (QMS) in accordance with industry standards (e.g., ISO 9001).
- Establish quality control procedures, inspection protocols, and testing methodologies for raw materials, in-process production, and finished goods.
- Lead and mentor a team of QA inspectors and technicians, providing guidance and training.
- Conduct regular audits of production processes to identify areas of non-conformance and implement corrective actions.
- Analyze quality data, identify trends, and develop strategies for continuous improvement in product quality and process efficiency.
- Manage customer feedback and complaints related to product quality, ensuring timely and effective resolution.
- Collaborate with R&D, production, and engineering teams to ensure new products meet quality requirements.
- Oversee documentation control, ensuring all quality-related records are accurate and up-to-date.
- Stay informed about industry best practices, regulatory changes, and emerging quality assurance technologies.
- Prepare comprehensive reports on quality performance, audit findings, and improvement initiatives for senior management.
- Bachelor's degree in Engineering (Industrial, Mechanical, Chemical), Quality Management, or a related technical field.
- Minimum of 7 years of progressive experience in quality assurance within a manufacturing environment.
- Proven expertise in implementing and managing Quality Management Systems (QMS).
- Strong understanding of statistical process control (SPC), Six Sigma, Lean Manufacturing principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Demonstrated leadership abilities with experience managing and motivating teams.
- Exceptional communication, interpersonal, and reporting skills.
- Proficiency in quality management software and tools.
- Ability to work independently, manage multiple projects, and maintain high standards in a remote setting.
- Relevant certifications such as Certified Quality Manager (CQM) or Six Sigma Black Belt are highly desirable.
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5
Remote Lead Production Quality Assurance Manager
Posted 21 days ago
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Job Description
Our client is actively searching for a dedicated and experienced Lead Production Quality Assurance Manager to spearhead their quality control initiatives within a fully remote framework. This senior position is vital for ensuring that all manufactured products meet the highest standards of quality, reliability, and customer satisfaction. The successful candidate will be responsible for developing, implementing, and maintaining comprehensive quality management systems (QMS) tailored for a remote and distributed manufacturing environment. This includes establishing robust quality control procedures, conducting rigorous inspections and audits, and analyzing quality data to identify trends and areas for systemic improvement.
You will lead a team of quality assurance professionals, providing guidance, mentorship, and performance management through virtual channels. Key duties involve defining quality metrics and KPIs, overseeing product testing protocols, and working closely with production and engineering teams to address and resolve any quality-related issues promptly. This remote role requires a deep understanding of quality methodologies such as Six Sigma and ISO standards, as well as experience with quality management software. The ability to foster a strong quality-focused culture across geographically dispersed teams is paramount. You will also be responsible for managing supplier quality, ensuring that all raw materials and components meet stringent specifications. Strong analytical, problem-solving, and communication skills are essential for effective collaboration and decision-making in this remote capacity. This is an outstanding opportunity for a seasoned quality professional to make a significant impact on product excellence and drive continuous improvement from anywhere. The candidate must demonstrate a proven ability to manage complex quality challenges and lead teams effectively in a virtual setting. A commitment to exceeding customer expectations through superior product quality is expected.
Location: Eldoret, Uasin Gishu, KE (Fully Remote)
You will lead a team of quality assurance professionals, providing guidance, mentorship, and performance management through virtual channels. Key duties involve defining quality metrics and KPIs, overseeing product testing protocols, and working closely with production and engineering teams to address and resolve any quality-related issues promptly. This remote role requires a deep understanding of quality methodologies such as Six Sigma and ISO standards, as well as experience with quality management software. The ability to foster a strong quality-focused culture across geographically dispersed teams is paramount. You will also be responsible for managing supplier quality, ensuring that all raw materials and components meet stringent specifications. Strong analytical, problem-solving, and communication skills are essential for effective collaboration and decision-making in this remote capacity. This is an outstanding opportunity for a seasoned quality professional to make a significant impact on product excellence and drive continuous improvement from anywhere. The candidate must demonstrate a proven ability to manage complex quality challenges and lead teams effectively in a virtual setting. A commitment to exceeding customer expectations through superior product quality is expected.
Location: Eldoret, Uasin Gishu, KE (Fully Remote)
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Pharmaceutical Quality Assurance Manager
Posted 21 days ago
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Job Description
Our client is seeking a highly qualified and experienced Pharmaceutical Quality Assurance Manager to lead their quality systems and compliance efforts within a fully remote framework. This crucial role ensures that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and maintaining robust quality management systems, including SOPs, batch record review, deviation management, CAPA, change control, and internal audits. Key responsibilities include ensuring compliance with cGMP, FDA, and other relevant regulatory guidelines. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory affairs. Strong leadership, analytical, and problem-solving skills are essential. As this is a fully remote position, exceptional written and verbal communication skills are paramount for effective collaboration with manufacturing teams, R&D, and regulatory bodies across different locations. You must be self-motivated, detail-oriented, and capable of managing multiple complex projects with a high degree of accuracy. This role offers the significant opportunity to ensure the safety and efficacy of pharmaceutical products while working flexibly from anywhere. You will play a critical role in maintaining the integrity of the company's quality operations and fostering a culture of continuous quality improvement. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field is required. A Master's degree or relevant professional certifications are advantageous. A minimum of 7-10 years of progressive experience in pharmaceutical quality assurance and quality control, with a significant portion in a management or supervisory role, is essential. Experience with electronic quality management systems is a plus. This position is fully remote, supporting quality assurance operations that may be connected to Mombasa, Mombasa, KE . If you are a seasoned QA professional dedicated to upholding the highest standards in the pharmaceutical industry, we encourage you to apply.
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7
Principal Pharmaceutical Quality Assurance Manager
Posted 21 days ago
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Job Description
Our client is seeking a highly experienced and strategic Principal Pharmaceutical Quality Assurance Manager to lead and enhance their quality systems. This is a crucial, fully remote position requiring extensive expertise in pharmaceutical regulations, GMP, and quality management principles. You will be responsible for developing, implementing, and maintaining robust quality assurance programs that ensure product integrity, regulatory compliance, and operational excellence across all functions. The role involves overseeing audits (internal and external), managing deviations and CAPAs, reviewing and approving documentation (e.g., batch records, validation protocols), and driving continuous improvement initiatives. You will collaborate closely with R&D, manufacturing, regulatory affairs, and other departments to foster a culture of quality throughout the organization. The ideal candidate will possess strong analytical skills, meticulous attention to detail, and the ability to make sound decisions in complex regulatory environments. This remote role requires exceptional leadership qualities and the capability to effectively manage a global team and processes. Your insights will be critical in identifying potential quality risks and implementing proactive solutions. This is an opportunity to make a significant impact on patient safety and product quality within a leading pharmaceutical organization.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global regulatory standards (e.g., FDA, EMA, WHO).
- Lead and manage internal and external audits, ensuring readiness for regulatory inspections.
- Oversee the investigation of deviations, out-of-specification (OOS) results, and customer complaints, implementing effective corrective and preventive actions (CAPA).
- Review and approve critical quality documents, including SOPs, batch records, validation reports, and change controls.
- Provide quality oversight for product development, manufacturing, and lifecycle management.
- Train and mentor QA staff and other personnel on quality systems and regulatory requirements.
- Drive continuous improvement initiatives to enhance product quality and process efficiency.
- Act as a primary quality contact for regulatory agencies and external partners.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Ensure the quality of outsourced activities and contract manufacturing organizations.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 12 years of experience in pharmaceutical quality assurance and quality control, with a significant portion in leadership roles.
- In-depth knowledge of cGMP, ICH guidelines, and global regulatory requirements.
- Proven experience in developing and managing QMS, conducting audits, and handling regulatory inspections.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong leadership and team management capabilities, especially in a remote setting.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly.
- Experience with pharmaceutical manufacturing processes and product development is essential.
- Proficiency in quality management software.
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8
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
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Job Description
Our client, a leading innovator in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to join their expanding operations. This is a pivotal, fully remote position requiring a deep commitment to upholding the highest standards of quality and compliance. The successful candidate will be responsible for developing, implementing, and maintaining the company's quality management system in accordance with GMP, GCP, and other relevant regulatory guidelines. Key duties include overseeing all QA activities, conducting internal and external audits, managing deviations and CAPA systems, and ensuring the readiness for regulatory inspections. You will also be involved in product lifecycle management, risk assessments, and validation activities. This role demands an expert understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control principles. The ability to lead cross-functional teams, mentor junior QA staff, and drive continuous improvement initiatives is essential. Strong analytical and problem-solving skills are required to identify and resolve quality issues effectively. Excellent written and verbal communication skills are necessary for preparing reports, documentation, and liaising with regulatory bodies and stakeholders. As a remote role, exceptional organizational skills and the ability to work autonomously, manage time effectively, and maintain rigorous attention to detail are critical. This is an exceptional opportunity for a seasoned QA professional to make a significant contribution to the development and manufacturing of life-saving medicines from a remote location. You will play a crucial role in ensuring product safety, efficacy, and compliance across all stages of development and production.
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