1045 Lead Pharmaceutical Quality Assurance Manager jobs in Nairobi
Lead Pharmaceutical Quality Assurance Manager
Posted 19 days ago
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Job Description
Our client, a globally recognized pharmaceutical company committed to improving health outcomes, is seeking a highly motivated and experienced Lead Pharmaceutical Quality Assurance Manager. This is a pivotal, fully remote role that will oversee the quality assurance functions across our client's diverse product lines. The successful candidate will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) in compliance with global regulatory standards (e.g., GMP, GDP, ICH guidelines). You will lead a team of QA professionals, ensuring adherence to strict quality protocols throughout the product lifecycle, from research and development to manufacturing and distribution. Key responsibilities include managing internal and external audits, conducting risk assessments, investigating deviations and out-of-specification results, and implementing corrective and preventive actions (CAPAs). The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control principles. You must have exceptional leadership skills, the ability to drive continuous improvement, and a meticulous attention to detail. This role demands strong analytical skills to interpret complex data, resolve quality issues, and make informed decisions that uphold the highest standards of product safety and efficacy. This is an excellent opportunity for a seasoned QA professional to make a significant impact in a remote-first environment, contributing to the development and delivery of life-saving medications. The work involves significant interaction with regulatory bodies and internal stakeholders, all managed remotely.
Responsibilities:
Responsibilities:
- Lead and manage the Quality Assurance department, ensuring compliance with all relevant pharmaceutical regulations and standards.
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Oversee all aspects of batch record review, product release, and stability testing programs.
- Conduct internal audits and host regulatory inspections, ensuring all findings are addressed promptly.
- Investigate deviations, customer complaints, and product quality issues, implementing effective CAPAs.
- Manage the change control process and ensure that all changes are assessed for their impact on product quality.
- Provide training and mentorship to QA staff.
- Collaborate with R&D, manufacturing, and regulatory affairs to ensure product quality throughout its lifecycle.
- Stay updated on evolving regulatory requirements and industry best practices.
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance.
- Extensive knowledge of cGMP, GDP, and ICH guidelines.
- Proven experience in managing regulatory inspections and audits (e.g., FDA, EMA).
- Strong leadership, team management, and interpersonal skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Proficiency in quality risk management principles.
- Exceptional written and verbal communication skills.
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Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 19 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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1
Process Improvement Engineer - Manufacturing
Posted 9 days ago
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Job Description
Our client, a prominent manufacturing firm, is seeking an innovative and experienced Process Improvement Engineer to lead their operational excellence initiatives. This is a fully remote position requiring a strategic mindset and a deep understanding of lean manufacturing principles, Six Sigma methodologies, and statistical process control. You will be instrumental in identifying bottlenecks, eliminating waste, and driving continuous improvement across manufacturing processes to enhance efficiency, quality, and cost-effectiveness. Your expertise will be vital in optimizing production workflows and implementing best practices.
Key responsibilities include analyzing current manufacturing processes, identifying areas for improvement through data collection and analysis, and designing and implementing new, more efficient processes. You will develop and execute projects focused on waste reduction, cycle time optimization, and quality enhancement. This role involves collaborating closely with production teams, quality assurance, and management to ensure successful implementation of improvements and to foster a culture of continuous improvement throughout the organization. Developing and delivering training on process improvement techniques will also be a significant aspect of your role.
The ideal candidate will possess a Bachelor's degree in Industrial Engineering, Manufacturing Engineering, or a related field, with at least 5 years of experience in process improvement within a manufacturing environment. Certifications in Lean or Six Sigma (Green Belt or Black Belt) are highly preferred. Proven experience in leading cross-functional teams and successfully implementing process improvement projects is essential. Excellent analytical, problem-solving, and project management skills are a must. Proficiency in process mapping software, statistical analysis tools, and general data analysis software is required. Strong communication and interpersonal skills are necessary to effectively engage with all levels of the organization and drive consensus on proposed changes. This role requires a highly motivated and self-directed individual capable of working effectively in a remote capacity, supporting operational sites including those in the Mlolongo, Machakos, KE vicinity.
We are looking for a change agent who can inspire and guide teams towards achieving higher levels of operational performance. If you are passionate about driving efficiency and quality through innovative engineering solutions and thrive in a remote work environment, we encourage you to apply for this impactful role.
Key responsibilities include analyzing current manufacturing processes, identifying areas for improvement through data collection and analysis, and designing and implementing new, more efficient processes. You will develop and execute projects focused on waste reduction, cycle time optimization, and quality enhancement. This role involves collaborating closely with production teams, quality assurance, and management to ensure successful implementation of improvements and to foster a culture of continuous improvement throughout the organization. Developing and delivering training on process improvement techniques will also be a significant aspect of your role.
The ideal candidate will possess a Bachelor's degree in Industrial Engineering, Manufacturing Engineering, or a related field, with at least 5 years of experience in process improvement within a manufacturing environment. Certifications in Lean or Six Sigma (Green Belt or Black Belt) are highly preferred. Proven experience in leading cross-functional teams and successfully implementing process improvement projects is essential. Excellent analytical, problem-solving, and project management skills are a must. Proficiency in process mapping software, statistical analysis tools, and general data analysis software is required. Strong communication and interpersonal skills are necessary to effectively engage with all levels of the organization and drive consensus on proposed changes. This role requires a highly motivated and self-directed individual capable of working effectively in a remote capacity, supporting operational sites including those in the Mlolongo, Machakos, KE vicinity.
We are looking for a change agent who can inspire and guide teams towards achieving higher levels of operational performance. If you are passionate about driving efficiency and quality through innovative engineering solutions and thrive in a remote work environment, we encourage you to apply for this impactful role.
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2
Remote Process Improvement Engineer - Industrial
Posted 3 days ago
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Job Description
Our client is seeking a highly analytical and results-oriented Process Improvement Engineer to join their operations on a remote contract basis. This position is focused on identifying, analyzing, and optimizing industrial processes to enhance efficiency, reduce costs, and improve overall productivity. You will leverage your expertise in Lean Six Sigma and other process improvement methodologies to drive significant operational enhancements across various departments. This role requires a proactive approach to problem-solving and a strong ability to collaborate effectively in a virtual setting.
Responsibilities:
Responsibilities:
- Analyze existing industrial processes to identify bottlenecks, inefficiencies, and areas for improvement.
- Develop and implement data-driven strategies to optimize workflows, reduce waste, and improve quality.
- Design and conduct experiments to test process changes and measure their impact.
- Utilize Lean Six Sigma tools and methodologies (e.g., DMAIC, Kaizen) to drive continuous improvement initiatives.
- Create process documentation, flowcharts, and standard operating procedures.
- Train and mentor staff on process improvement techniques and best practices.
- Collaborate with cross-functional teams, including operations, engineering, and management, to implement solutions.
- Monitor the performance of implemented improvements and ensure sustained results.
- Prepare detailed reports and presentations on process analysis, recommendations, and outcomes.
- Stay abreast of industry trends and advancements in process engineering and optimization.
- Bachelor's degree in Industrial Engineering, Mechanical Engineering, Operations Management, or a related field.
- Proven experience (minimum 4 years) in process improvement, operational excellence, or industrial engineering roles.
- Strong knowledge and practical application of Lean Manufacturing and Six Sigma principles (Green Belt or Black Belt certification is highly preferred).
- Proficiency in data analysis tools such as Excel, Minitab, or similar statistical software.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong project management and organizational abilities.
- Exceptional communication, presentation, and interpersonal skills, with the ability to influence stakeholders remotely.
- Experience in virtual collaboration tools and working effectively in a remote team environment.
- Ability to work independently and manage multiple projects simultaneously.
- Experience within manufacturing or heavy industry settings is a plus.
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3
Remote Industrial Engineer - Process Improvement Specialist
Posted 9 days ago
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Job Description
Our client, a global manufacturing leader, is seeking a highly skilled Remote Industrial Engineer specializing in Process Improvement to join their operational excellence team. This fully remote position requires a strategic thinker with a strong analytical background to identify, analyze, and optimize manufacturing and operational processes from a distance. You will be instrumental in driving efficiency, reducing waste, and improving overall productivity across various facilities. Responsibilities include conducting remote process analysis using data visualization and simulation tools, identifying bottlenecks and inefficiencies, developing and implementing lean manufacturing principles and methodologies, designing optimized workflows, collaborating with on-site teams to implement changes, and monitoring the impact of improvements. The ideal candidate will possess a Bachelor's or Master's degree in Industrial Engineering or a related field, coupled with significant experience in process improvement, lean manufacturing, Six Sigma, or operations management. Proficiency in process modeling software (e.g., Arena, AnyLogic), data analysis tools (e.g., Excel, Minitab), and visualization tools is essential. You must possess exceptional analytical, problem-solving, and project management skills, with the ability to communicate complex technical information clearly and persuasively to cross-functional teams. While this role is remote, it involves deep engagement with operational challenges faced by facilities around Mlolongo, Machakos, KE , and globally. This is an exciting opportunity for an experienced Industrial Engineer to apply their expertise in a flexible, remote work setting.
Key Responsibilities:
Key Responsibilities:
- Analyze existing industrial processes, workflows, and systems to identify areas for improvement.
- Utilize process mapping, data analysis, and simulation techniques to diagnose inefficiencies and bottlenecks.
- Develop and implement strategies based on lean manufacturing, Six Sigma, and other continuous improvement methodologies.
- Design and propose optimized operational layouts and workflows.
- Collaborate with on-site operations teams to implement process changes and best practices.
- Develop and track key performance indicators (KPIs) to measure the effectiveness of implemented improvements.
- Prepare detailed reports and presentations on process analysis, findings, and recommendations.
- Provide training and guidance to site personnel on new processes and methodologies.
- Ensure adherence to safety, quality, and operational standards.
- Drive a culture of continuous improvement within the organization.
- Bachelor's or Master's degree in Industrial Engineering, Mechanical Engineering, Operations Management, or a related discipline.
- Minimum of 5 years of experience in industrial engineering, with a strong focus on process improvement.
- Proven track record in implementing lean manufacturing, Six Sigma (Green Belt or Black Belt preferred), or other continuous improvement initiatives.
- Proficiency with process simulation software, statistical analysis tools, and data visualization platforms.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong project management and organizational abilities.
- Effective communication and interpersonal skills for collaborating with diverse teams remotely.
- Ability to work independently and manage multiple projects simultaneously.
- Familiarity with supply chain and logistics operations is a plus.
- Access to a reliable internet connection and appropriate remote working setup.
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4
Senior Manufacturing Engineer - Remote Process Improvement
Posted 15 days ago
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Job Description
Our client, a leading entity in the manufacturing sector, is seeking an accomplished Senior Manufacturing Engineer to join their globally distributed team. This is a **fully remote** position, focused on optimizing production processes, enhancing efficiency, and driving innovation in manufacturing operations. You will play a crucial role in analyzing existing manufacturing systems, identifying areas for improvement, and implementing advanced engineering solutions to boost productivity, reduce costs, and ensure the highest quality standards. The ideal candidate will possess a strong background in manufacturing principles, process design, automation, and quality control. Expertise in methodologies such as Lean Manufacturing, Six Sigma, and Kaizen is essential. Responsibilities include developing and implementing process improvements, designing production layouts, evaluating new manufacturing technologies, and collaborating with cross-functional teams, including production, quality assurance, and supply chain. You will also be responsible for troubleshooting production issues, conducting root cause analysis, and developing corrective actions. This remote role requires excellent problem-solving skills, a proactive approach, and the ability to work independently while effectively communicating and coordinating with colleagues across different time zones. Strong analytical and data interpretation skills are vital for performance monitoring and reporting. Our client is committed to providing a supportive and collaborative remote work environment, offering opportunities for professional development and career advancement. This is an exceptional opportunity to apply your engineering expertise to drive significant improvements in manufacturing operations on a global scale, enjoying the autonomy and flexibility of a remote position. If you are a results-oriented manufacturing professional with a passion for process excellence and innovation, we encourage you to apply. Your contributions will be instrumental in maintaining our client's competitive edge in the industry.
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5
Pharmaceutical Quality Assurance Manager
Posted 19 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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6
Principal Pharmaceutical Quality Assurance Manager
Posted 4 days ago
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Job Description
Our client is seeking a highly accomplished Principal Pharmaceutical Quality Assurance Manager to oversee and elevate their quality systems. This is a critical, fully remote leadership position within their global pharmaceutical operations. The ideal candidate will possess extensive experience in pharmaceutical quality assurance, regulatory compliance, and quality management systems. You will be responsible for developing, implementing, and maintaining comprehensive QA policies and procedures to ensure compliance with international regulatory standards (e.g., FDA, EMA, WHO). This includes overseeing internal and external audits, managing deviations, change controls, and CAPA systems. The Principal QA Manager will lead cross-functional teams, providing expert guidance on quality-related matters and fostering a strong quality culture throughout the organization. You will review and approve critical quality documents, including validation protocols, manufacturing batch records, and stability studies. Experience with GxP environments (GMP, GLP, GCP) is essential. As a remote-first leader, you will leverage digital collaboration tools to effectively manage global teams and initiatives. The ability to identify potential quality risks, implement robust risk mitigation strategies, and drive continuous improvement in quality processes is paramount. Strong analytical, problem-solving, and decision-making skills are required. You will also play a key role in preparing for and hosting regulatory inspections. This is an exceptional opportunity to shape the quality landscape of a leading pharmaceutical company, driving excellence and ensuring product integrity from a flexible, remote work setting. Your expertise will be vital in maintaining the highest standards of quality and compliance.
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7
Senior Pharmaceutical Quality Assurance Manager
Posted 19 days ago
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Job Description
Our client is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Manager to lead quality initiatives within their dynamic organization. This is a fully remote position, requiring a deep understanding of pharmaceutical manufacturing, regulatory compliance, and quality management systems. You will be responsible for ensuring that all products meet the highest standards of quality, safety, and efficacy, adhering strictly to Good Manufacturing Practices (GMP) and relevant international regulatory guidelines. Key responsibilities include developing and implementing QA policies and procedures, overseeing internal and external audits, managing deviation investigations, and driving corrective and preventive actions (CAPA). The ideal candidate will have a proven track record in pharmaceutical quality assurance, with expertise in quality risk management and validation processes. Experience with regulatory submissions and inspections is highly desirable. This role is remote-first, demanding exceptional organizational skills, strong analytical abilities, and the capacity to manage a distributed team effectively through virtual collaboration. You will work closely with research and development, manufacturing, and regulatory affairs departments to ensure seamless integration of quality standards across all operations. We are looking for a proactive leader with excellent communication and interpersonal skills, capable of fostering a strong quality culture throughout the organization. A comprehensive knowledge of pharmacopeias (e.g., USP, EP, BP) is essential. Your expertise will be crucial in maintaining the integrity and reputation of our client's pharmaceutical offerings, with a focus on operations related to the Mombasa, Mombasa, KE region.
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8
Remote Pharmaceutical Quality Assurance Manager
Posted 10 days ago
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Job Description
Our client, a global leader in the pharmaceutical industry, is searching for a highly skilled and experienced Pharmaceutical Quality Assurance Manager to lead their quality initiatives. This is a critical, fully remote position that allows you to drive compliance and excellence from any location. You will be responsible for establishing, implementing, and maintaining the company's quality management system (QMS) in accordance with international regulatory standards (e.g., GMP, ISO). Key duties include overseeing quality control processes, conducting internal and external audits, managing deviations and CAPAs (Corrective and Preventive Actions), and ensuring product quality and safety throughout the lifecycle. This role demands a deep understanding of pharmaceutical manufacturing processes, regulatory requirements, and quality risk management. You will lead and mentor a team of QA professionals, fostering a culture of continuous improvement and compliance. Strong analytical skills and the ability to interpret complex regulatory guidelines are essential. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field is required, coupled with a minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical sector. Proven experience in developing and managing QMS, conducting regulatory inspections, and leading cross-functional teams in a remote setting is crucial. Excellent communication, leadership, and problem-solving skills are paramount. If you are a dedicated QA professional committed to upholding the highest standards in pharmaceuticals and thrive in a fully remote work environment, we invite you to apply.
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