287 Senior Pharmaceutical Quality Assurance Specialist jobs in Nairobi

• Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in compliance with national and international pharmaceutical regulations (e.g., GMP, ICH guidelines).
• Conduct internal and external audits of manufacturing facilities, suppliers, and contract manufacturers to assess compliance and identify areas for improvement.
• Review and approve batch records, validation protocols, and technical documentation to ensure accuracy and adherence to specifications.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Manage the change control process, evaluating the impact of proposed changes on product quality and regulatory compliance.
• Develop and deliver training programs on quality assurance principles and GMP practices to relevant personnel.
• Monitor and analyze quality metrics, identifying trends and providing reports to management to drive continuous improvement initiatives.
• Participate in regulatory inspections and respond to inquiries from health authorities.
• Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure seamless integration of quality processes.
• Contribute to the continuous improvement of QA processes and procedures, seeking efficiencies and enhancing overall quality performance.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is preferred.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP regulations, quality control principles, and pharmaceutical manufacturing processes.
• Proven experience in conducting audits, managing CAPAs, and handling change control.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent written and verbal communication skills, with the ability to effectively present complex information.
• Experience with regulatory submissions and interactions with health authorities.
• Proficiency in relevant software, including QMS databases and statistical analysis tools.
• Ability to work effectively both independently and as part of a cross-functional team.
• Demonstrated leadership potential and a commitment to ethical practices.

• Develop, implement, and maintain quality management systems and procedures.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Conduct internal audits and participate in external audits of suppliers and partners.
• Investigate deviations, out-of-specifications (OOS) results, and customer complaints.
• Develop and implement corrective and preventive actions (CAPA) to address quality issues.
• Ensure compliance with relevant regulatory requirements (e.g., FDA, EMA, local health authorities).
• Train personnel on quality assurance policies and procedures.
• Monitor and analyze quality metrics and trends, reporting findings to management.
• Participate in process validation and qualification activities.
• Manage the change control process effectively.
• Stay updated on regulatory changes and industry best practices in pharmaceutical quality assurance.
• Contribute to the continuous improvement of quality systems.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 3-5 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of GMP, GLP, and other relevant quality standards.
• Familiarity with regulatory submission processes and requirements.
• Strong understanding of pharmaceutical manufacturing processes.
• Excellent analytical, problem-solving, and investigative skills.
• Exceptional attention to detail and accuracy.
• Strong written and verbal communication skills, adapted for remote collaboration.
• Ability to work independently, prioritize tasks, and manage time effectively in a remote environment.
• Proficiency in quality management software and MS Office Suite.

• Developing, implementing, and maintaining quality assurance systems and procedures in accordance with cGMP, ICH guidelines, and other relevant regulations.
• Reviewing and approving manufacturing batch records, analytical data, and validation protocols.
• Conducting internal audits and participating in external regulatory inspections.
• Investigating deviations, out-of-specification (OOS) results, and customer complaints, and implementing corrective and preventive actions (CAPAs).
• Managing change control processes and ensuring all changes are properly assessed and documented.
• Preparing and submitting quality-related documentation for regulatory filings.
• Training QA/QC personnel and other relevant staff on quality systems and compliance.
• Monitoring and assessing supplier quality performance.
• Staying current with evolving pharmaceutical regulations and industry best practices.
• Contributing to the continuous improvement of the Quality Management System (QMS).

• Develop, implement, and manage the company's Quality Management System (QMS) to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH guidelines).
• Oversee and participate in internal and external audits of manufacturing sites, contract manufacturers, and suppliers.
• Review and approve critical quality documents, including batch records, validation protocols, SOPs, and change controls.
• Lead and participate in investigations of deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out-of-Specification) results.
• Assess and manage quality risks associated with product development, manufacturing, and supply chain.
• Provide training and guidance to internal teams and external partners on quality assurance principles and regulatory requirements.
• Monitor and analyze quality metrics to identify trends and areas for improvement.
• Collaborate with regulatory affairs to ensure compliance with all applicable regulations.
• Contribute to the development and continuous improvement of quality policies and procedures.
• Stay current with evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.
• Manage quality aspects of product lifecycle, from development through post-market surveillance.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
• Extensive knowledge of GMP, GLP, GCP, and other relevant pharmaceutical quality systems and regulations.
• Proven experience in conducting and managing audits, investigations, and risk assessments.
• Strong understanding of pharmaceutical manufacturing processes and product development.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional written and verbal communication skills, with the ability to communicate complex technical and regulatory information clearly.
• Ability to work independently, manage multiple projects, and prioritize effectively in a remote setting.
• Proficiency in quality management software and standard office applications.

• Develop and implement robust risk management policies and procedures across various financial areas, including market risk, credit risk, operational risk, and liquidity risk.
• Conduct comprehensive risk assessments and identify potential vulnerabilities and threats to the organization.
• Design and oversee the execution of risk mitigation strategies and control measures.
• Ensure the firm's compliance with relevant financial regulations (e.g., central bank guidelines, international standards).
• Monitor risk exposures and provide regular reports to senior management and the board of directors.
• Lead internal and external audits related to risk management and compliance.
• Develop and deliver risk management training programs to employees at all levels.
• Stay abreast of changes in the regulatory environment and industry best practices.
• Collaborate with legal, compliance, and business units to integrate risk management into strategic decision-making.
• Manage and mentor a team of risk analysts and specialists.

• Master's degree in Finance, Economics, Risk Management, or a related quantitative field. Professional certifications such as FRM, PRM, or CFA are highly desirable.
• Minimum of 8 years of progressive experience in financial risk management, with a significant focus on regulatory compliance.
• In-depth knowledge of financial markets, instruments, and associated risks.
• Proven expertise in implementing and managing risk management frameworks (e.g., Basel Accords, Solvency II).
• Strong understanding of financial regulations and compliance requirements in the banking and financial services sector.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex risk concepts to diverse audiences.
• Proven leadership and team management experience.
• Ability to work independently and manage multiple priorities in a fast-paced, remote environment.
• Must possess a reliable high-speed internet connection and a dedicated home office setup conducive to managing sensitive financial information and remote collaboration.

Lets Write Africa's Story Together
Old Mutual is a firm believer in the African opportunity and our diverse talent reflects this.

Job Description
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Establishes and embeds compliance in area of responsibility. Ensures compliance within area by implementation of compliance risk management and monitoring plan. Reports on compliance breaches to line management and Senior Compliance Officer/Compliance Executive. Facilitates resolution of compliance breaches. Assists in mitigation of compliance risk. Utilises limited legislation, and impact of legislation on the BU/functional area is limited."

Responsibilities
Regulatory and Compliance Management

Investigate all kinds of incidents and reports and provide expert advice to more senior colleagues. Minimize risk exposures and ensure adherence with regulatory standards by working with all internal functions to make sure compliance programs are properly implemented.

Regulatory Affairs

Take responsibility for managing and delivering a designated work program.

Quality Management System

Contribute to the identification and evaluation of current policies and business processes that are in the scope of the quality management system (QMS); contribute to the design of the QMS; provide specialist quality management input to the drafting of new policies and procedures and the design of business processes; contribute to the quantification of the costs and business benefits of change.

Audit Compliance

Manage a portfolio of audit assignments. Ensure that the team plans and delivers audits that cover identified risk areas, and that appropriate corrective actions are agreed on with auditees. Resolve issues arising from audits and refer serious or contentious issues to the audit program leader.

Stakeholder Engagement

Contribute to stakeholder engagement by identifying stakeholders; by finding out their needs, issues, and concerns; and by reacting to these needs, issues, and concerns, arranging meetings and events and drafting supporting materials to promote understanding and commitment.

Policy Development and Implementation

Work within established procedures to achieve specified goals.

Organizational Capability Building

Provide coaching to team members to develop their skills.

Information and Business Advice

Resolve queries from internal or external customers or suppliers by providing information on complex processes and the related policies, referring issues to others where necessary for interpretation of policy.

Document Preparation

Organize and prepare complex documents using a variety of applications for technology devices, such as standard office software. Also responsible for gathering and summarizing data for special reports.

Skills
Compliance Software, Data Compilation, Engineering Standards, Legal Practices, Management Reporting, Oral Communications, Policies & Procedures, Presenting Solutions, Professional Presentation, QA Methodologies, Regulatory Compliance Management, Requirements Development

Competencies
Action Oriented

Balances Stakeholders

Financial Acumen

Instills Trust

Interpersonal Savvy

Manages Complexity

Optimizes Work Processes

Persuades

Education
NQF Level 7 - Degree, Advance Diploma or Postgraduate Certificate or equivalent

Closing Date
07 October 2025 , 23:59

The Old Mutual Story

• Develop, implement, and manage the organization's Safety Management System (SMS) in compliance with relevant aviation regulations.
• Conduct regular safety audits, inspections, and risk assessments of operations, facilities, and procedures.
• Investigate aviation safety incidents and accidents, identifying root causes and recommending corrective actions.
• Develop and deliver comprehensive safety training programs to all levels of personnel.
• Promote a positive safety culture and encourage proactive hazard reporting.
• Monitor aviation safety trends and regulatory changes, updating policies and procedures accordingly.
• Liaise with aviation regulatory authorities to ensure compliance and facilitate audits.
• Develop and manage safety performance indicators (SPIs) and safety performance targets (SPTs).
• Prepare detailed safety reports, analysis, and recommendations for senior management.
• Maintain safety-related documentation and records.
• Advise management on aviation safety best practices and emerging risks.

• Bachelor's degree in Aviation Management, Aerospace Engineering, Safety Science, or a related field.
• Minimum of 8 years of progressive experience in aviation safety management, preferably with an airline, MRO, or regulatory body.
• In-depth knowledge of ICAO standards, EASA/FAA regulations, and Safety Management Systems (SMS) principles.
• Proven experience in conducting safety investigations, hazard identification, and risk assessment.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication and presentation skills.
• Ability to work independently and manage complex projects in a remote environment.
• Certification in Aviation Safety Management (e.g., IATA SMS, ISAGO) is highly desirable.
• Proficiency with safety management software and data analysis tools.
• Familiarity with aircraft operations, maintenance, and air traffic control procedures.

• Develop, implement, and maintain the organization's Safety Management System (SMS) in accordance with ICAO Annex 19 and relevant national regulations.
• Conduct hazard identification, risk assessment, and mitigation planning for all aviation operations.
• Establish and manage safety reporting systems, ensuring timely investigation of incidents and accidents.
• Develop and deliver safety training programs for all levels of personnel.
• Conduct safety audits and inspections to ensure compliance with policies and procedures.
• Monitor safety performance indicators (SPIs) and key risk indicators (KRIs), reporting on trends and recommending corrective actions.
• Foster a positive safety culture through proactive communication, engagement, and leadership.
• Liaise with regulatory authorities and industry bodies on safety matters.
• Manage the safety documentation and records management system.
• Stay abreast of evolving aviation safety regulations, best practices, and emerging safety technologies.

• Conduct remote audits and inspections of aviation operators, maintenance organizations, and training facilities.
• Verify compliance with applicable aviation laws, regulations, and standards (e.g., ICAO, national civil aviation regulations).
• Evaluate safety management systems (SMS) and risk management processes.
• Review operational procedures, manuals, and documentation for adequacy and compliance.
• Investigate safety occurrences, incidents, and accidents, identifying root causes and contributing factors.
• Prepare detailed inspection reports, audit findings, and corrective action plans.
• Monitor the implementation and effectiveness of corrective actions.
• Provide guidance and clarification on regulatory requirements to industry stakeholders.
• Participate in safety promotion activities and working groups.
• Maintain up-to-date knowledge of aviation safety regulations and industry best practices.

• Bachelor's degree in Aviation Management, Aerospace Engineering, or a related technical field.
• Minimum of 8 years of experience in aviation operations, maintenance, safety management, or regulatory oversight.
• In-depth knowledge of national and international aviation regulations and standards.
• Experience with Safety Management Systems (SMS) and risk assessment methodologies.
• Strong analytical, investigative, and problem-solving skills.
• Excellent report writing and documentation skills.
• Proficiency in using relevant software for data analysis and reporting.
• Outstanding communication and interpersonal skills for effective remote interaction.
• Ability to work independently, manage time efficiently, and maintain objectivity.
• Relevant certifications or licenses in aviation safety or operations are highly desirable.
• Willingness to undertake periodic travel for on-site inspections when necessary.