1,969 Principal Pharmaceutical Quality Assurance Specialist jobs in Kenya
Principal Pharmaceutical Quality Assurance Specialist
Posted 11 days ago
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Job Description
Our client, a leading global pharmaceutical company, is seeking a highly experienced Principal Pharmaceutical Quality Assurance Specialist to join their esteemed remote team. This role is pivotal in ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, entirely managed through remote collaboration. You will be responsible for developing, implementing, and maintaining comprehensive quality management systems, including cGMP, GCP, and GLP compliance. Your duties will involve conducting internal audits, managing external audits, investigating deviations and CAPAs, and ensuring regulatory compliance with global health authorities. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle. A significant part of your role will involve risk assessment, trend analysis of quality data, and continuous improvement initiatives to enhance product quality and process robustness. You will also be involved in the review and approval of documentation, including validation protocols, batch records, and change controls. This position requires a deep understanding of pharmaceutical manufacturing processes, analytical testing, and regulatory requirements. The ideal candidate will possess a Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field, with a minimum of 8 years of progressive experience in pharmaceutical quality assurance. Exceptional analytical, problem-solving, and critical thinking skills are essential. Strong knowledge of regulatory guidelines (FDA, EMA) and experience with electronic quality management systems (eQMS) are highly desirable. You must be adept at working independently, managing complex quality projects remotely, and fostering a strong quality culture across distributed teams. This is a remarkable opportunity to contribute significantly to patient safety and drug quality within a world-class pharmaceutical organization, operating entirely in a remote capacity.
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Principal Pharmaceutical Quality Assurance Specialist (Remote)
Posted 21 days ago
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Job Description
Our client, a globally recognized leader in the Pharmaceutical industry, is seeking an experienced Principal Pharmaceutical Quality Assurance Specialist to join their esteemed team. This is a critical, fully remote position that plays a pivotal role in ensuring the highest standards of quality and compliance across all pharmaceutical operations. The ideal candidate will possess an in-depth understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements across key markets. You will be responsible for developing, implementing, and maintaining robust quality management systems, conducting internal and external audits, and driving continuous improvement initiatives. This role requires exceptional attention to detail, strong analytical skills, and the ability to effectively manage complex quality assurance processes from a remote setting.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and manage comprehensive quality assurance programs and systems in compliance with regulatory standards (e.g., FDA, EMA).
- Lead and conduct internal audits of manufacturing sites, laboratories, and distribution centers to ensure adherence to GMP, GLP, and other relevant regulations.
- Oversee the investigation of deviations, CAPA (Corrective and Preventive Actions) implementation, and change control processes.
- Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
- Provide expert guidance and support to cross-functional teams on quality-related matters.
- Participate in external regulatory inspections and host regulatory auditors.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Develop and deliver training programs on quality assurance best practices.
- Monitor industry trends and regulatory updates, ensuring the company remains compliant.
- Manage quality agreements with external partners and suppliers.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of pharmaceutical manufacturing processes, quality control, and regulatory affairs.
- Proven experience in leading and conducting GMP audits.
- Strong understanding of ICH guidelines and global regulatory requirements.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and commitment to quality.
- Superior written and verbal communication skills.
- Ability to work independently and manage multiple complex projects effectively in a remote environment.
- Experience with quality management software (e.g., TrackWise, LIMS).
- Must have a reliable internet connection and a suitable home office setup for this fully remote role .
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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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Senior Pharmaceutical Quality Assurance Manager, Regulatory Compliance
Posted 10 days ago
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Job Description
Our client is seeking a highly skilled and experienced Senior Pharmaceutical Quality Assurance Manager to ensure adherence to stringent regulatory standards in a fully remote capacity. This crucial role will oversee and implement robust quality management systems, guaranteeing compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant global regulations. You will be responsible for developing, implementing, and maintaining comprehensive quality assurance programs, including SOPs, quality risk management, and deviation investigations. Key duties involve conducting internal and external audits, managing regulatory inspections, and ensuring all documentation is accurate, complete, and compliant. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, drug development lifecycle, and regulatory submission requirements. You will lead and mentor a team of quality assurance professionals, fostering a culture of quality excellence and continuous improvement. This role requires strong analytical, problem-solving, and decision-making skills. You will collaborate closely with various departments, including R&D, Manufacturing, and Regulatory Affairs, to ensure consistent quality across all operations. Experience with quality agreements, change control, CAPA (Corrective and Preventive Actions) systems, and complaint handling is essential. We are looking for a candidate with a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field, coupled with a minimum of 8 years of progressive experience in pharmaceutical quality assurance and regulatory affairs. Proven experience in managing quality systems and preparing for regulatory audits (e.g., FDA, EMA) is mandatory. Exceptional communication and interpersonal skills are necessary to effectively lead remote teams and interact with regulatory agencies. This remote position offers the opportunity to make a significant impact on product quality and patient safety from anywhere. You will be a key contributor to ensuring the integrity and reliability of our client's pharmaceutical products, driving compliance and operational excellence. Your ability to interpret complex regulatory guidelines and translate them into practical, implementable procedures will be vital.
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Lead Regulatory Compliance Attorney
Posted 13 days ago
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Job Description
Our client is seeking a seasoned and highly experienced Lead Regulatory Compliance Attorney to ensure adherence to all legal and regulatory requirements. This is a fully remote position, offering the flexibility to manage compliance initiatives and advise the organization from anywhere. You will be responsible for interpreting complex regulations, developing and implementing compliance programs, and overseeing internal audits to ensure adherence to standards across various jurisdictions. The ideal candidate will possess a comprehensive understanding of regulatory frameworks relevant to our client's industry, strong analytical skills, and the ability to translate legal requirements into actionable business processes. Your responsibilities will include staying abreast of legislative changes, advising on potential compliance risks, developing training materials for employees, and managing relationships with regulatory bodies. You will also lead investigations into potential compliance breaches and recommend appropriate corrective actions. This role requires exceptional legal acumen, meticulous attention to detail, and outstanding communication skills to effectively articulate compliance strategies and requirements to both legal and non-legal stakeholders. The ability to work autonomously, manage multiple projects simultaneously, and drive a culture of compliance within a remote setting is paramount. This is a crucial position that offers the opportunity to shape and safeguard the legal integrity of the organization, contributing significantly to its sustained success and reputation. We are looking for an attorney with a proven track record in regulatory compliance, exceptional problem-solving capabilities, and a dedication to upholding the highest ethical standards in a dynamic and evolving legal landscape. Your expertise will be vital in navigating the complexities of the regulatory environment and ensuring robust adherence to all applicable laws and standards.
Responsibilities:
Responsibilities:
- Develop and implement comprehensive regulatory compliance programs.
- Interpret and advise on complex legal and regulatory requirements.
- Conduct internal audits and assessments to ensure compliance.
- Stay current with changes in legislation and regulatory frameworks.
- Develop and deliver compliance training to employees.
- Manage relationships with regulatory agencies and authorities.
- Investigate potential compliance violations and recommend corrective actions.
- Advise senior management on compliance risks and strategies.
- Draft and review compliance-related policies and procedures.
- Ensure ethical conduct and integrity across the organization.
- Juris Doctor (JD) or equivalent law degree.
- Admission to the bar and in good standing.
- Minimum of 8 years of experience focused on regulatory compliance, preferably in-house or at a reputable law firm.
- Deep understanding of relevant industry regulations (e.g., financial services, data privacy, environmental).
- Proven experience in developing and implementing compliance programs.
- Excellent analytical, research, and problem-solving skills.
- Strong negotiation and communication abilities, with the capacity to influence stakeholders.
- Demonstrated ability to manage complex projects and lead teams remotely.
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Lead Regulatory Compliance Counsel
Posted 20 days ago
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Job Description
Our client is seeking a highly experienced and knowledgeable Lead Regulatory Compliance Counsel to guide their legal and compliance functions. This is a fully remote position, offering the flexibility to manage complex regulatory matters from anywhere within Kenya. You will be responsible for ensuring that the company adheres to all relevant local and international laws, regulations, and industry standards. This includes developing, implementing, and monitoring compliance programs, conducting risk assessments, and providing expert legal advice on regulatory issues. The ideal candidate will have a comprehensive understanding of compliance frameworks, a strong track record in navigating regulatory landscapes, and exceptional analytical and problem-solving skills. You will lead a team of compliance professionals, mentor junior staff, and work closely with various departments to foster a culture of compliance throughout the organization. Key responsibilities include drafting and reviewing compliance policies, overseeing internal investigations, managing regulatory audits and inquiries, and staying abreast of evolving regulatory requirements. This role demands strategic thinking, impeccable judgment, and the ability to communicate complex legal and regulatory concepts clearly to diverse audiences. If you are a seasoned legal professional with a passion for compliance and seeking a challenging and impactful remote leadership role, we encourage you to apply.
Responsibilities:
Responsibilities:
- Develop, implement, and manage comprehensive regulatory compliance programs.
- Ensure adherence to all applicable laws, regulations, and industry standards.
- Conduct regular compliance risk assessments and develop mitigation strategies.
- Draft, review, and update compliance policies, procedures, and guidelines.
- Oversee internal investigations and respond to regulatory inquiries and audits.
- Provide expert legal counsel on regulatory matters to all levels of the organization.
- Lead and mentor a team of compliance officers and legal professionals.
- Stay informed about changes in regulations and advise on their impact.
- Promote a strong culture of compliance and ethical conduct.
- Liaise with external legal counsel and regulatory bodies as needed.
- Manage reporting requirements to regulatory agencies.
- Juris Doctor (J.D.) or equivalent law degree from a reputable institution.
- Admitted as an Advocate of the High Court of Kenya with a current practicing certificate.
- Minimum of 10 years of experience in regulatory compliance, with a significant portion in a legal counsel role.
- Proven experience in developing and implementing compliance programs within a corporate environment.
- Deep understanding of relevant industry-specific regulations and legal frameworks.
- Exceptional analytical, research, and problem-solving skills.
- Strong leadership, team management, and interpersonal abilities.
- Excellent written and verbal communication skills, with the ability to articulate complex legal concepts.
- High ethical standards and integrity.
- Ability to work independently, manage multiple priorities, and lead effectively in a remote setting.
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Senior Regulatory Compliance Counsel
Posted 6 days ago
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Job Description
Our client, a respected firm in the legal sector, is seeking an experienced and detail-oriented Senior Regulatory Compliance Counsel to join their fully remote legal team. This crucial role involves providing expert legal advice and guidance on a wide range of regulatory compliance matters. The Senior Counsel will be responsible for interpreting and applying complex legal and regulatory requirements across various jurisdictions relevant to our client's business operations. Key duties include developing, implementing, and maintaining robust compliance programs and policies, conducting compliance training for employees, and advising on the legal implications of new business initiatives. You will also be involved in responding to regulatory inquiries, managing internal investigations, and overseeing the legal aspects of audits and examinations. The ideal candidate will have a strong understanding of corporate law, regulatory frameworks, and best practices in compliance. Exceptional analytical, research, and drafting skills are essential. This is a remote-first position, requiring a self-starter with excellent time management and organizational abilities, capable of managing a demanding workload independently. Strong interpersonal and communication skills are vital for collaborating effectively with internal teams and external stakeholders in a virtual environment. Membership in good standing with the relevant bar association is mandatory. A Juris Doctor (JD) or equivalent law degree, with at least 6-8 years of post-qualification experience focusing on regulatory compliance, corporate governance, or a related field, is required. Experience within a law firm or in-house legal department, preferably with exposure to the financial services or technology sectors, would be a significant asset. This position offers the opportunity to shape compliance strategies and contribute significantly to our client's commitment to ethical and lawful business conduct, all while working remotely.
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6
Lead Environmental Lawyer, Regulatory Compliance
Posted 19 days ago
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Job Description
Our client is seeking a highly experienced Lead Environmental Lawyer to champion their regulatory compliance and sustainability initiatives. This is a fully remote position, allowing you to provide expert legal counsel on environmental matters from anywhere. You will be responsible for interpreting and applying complex environmental laws and regulations, advising on compliance strategies, and managing environmental legal risks for the organization. This role involves close collaboration with internal teams, external counsel, and regulatory bodies. The ideal candidate possesses a deep understanding of national and international environmental legislation, strong analytical and problem-solving skills, and the ability to navigate intricate legal landscapes.
Key responsibilities include:
The successful candidate will hold a Bachelor of Laws (LLB) degree and a Post Graduate Diploma in Legal Practice, with at least 7 years of post-admission experience specializing in environmental law. Proven experience in regulatory compliance, environmental litigation, and transactional environmental work is essential. Strong research, writing, and advocacy skills are required. The ability to manage multiple priorities and work effectively in a remote, collaborative environment is crucial. This is an excellent opportunity to make a significant impact on environmental stewardship within a forward-thinking organization, supporting operations near Malindi, Kilifi, KE .
Key responsibilities include:
- Providing expert legal advice on all aspects of environmental law and regulations relevant to the company's operations.
- Ensuring the company's compliance with environmental permits, licenses, and reporting requirements.
- Developing and implementing environmental compliance policies and procedures.
- Reviewing and advising on environmental impact assessments (EIAs) and related documentation.
- Representing the company in legal proceedings, administrative hearings, and negotiations with regulatory agencies.
- Assisting in the management of environmental liabilities and remediation efforts.
- Staying abreast of evolving environmental legislation, case law, and policy changes.
- Conducting legal research and providing analysis on emerging environmental issues.
- Advising on sustainable business practices and corporate social responsibility initiatives.
- Collaborating with engineering, operations, and EHS (Environment, Health, and Safety) teams to mitigate environmental risks.
The successful candidate will hold a Bachelor of Laws (LLB) degree and a Post Graduate Diploma in Legal Practice, with at least 7 years of post-admission experience specializing in environmental law. Proven experience in regulatory compliance, environmental litigation, and transactional environmental work is essential. Strong research, writing, and advocacy skills are required. The ability to manage multiple priorities and work effectively in a remote, collaborative environment is crucial. This is an excellent opportunity to make a significant impact on environmental stewardship within a forward-thinking organization, supporting operations near Malindi, Kilifi, KE .
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7
Senior Risk Analyst, Regulatory Compliance
Posted 20 days ago
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Job Description
Our client, a rapidly growing international financial institution, is actively recruiting a Senior Risk Analyst with a focus on regulatory compliance. This is a fully remote position, offering a flexible work environment to manage complex risk portfolios. You will be responsible for identifying, assessing, and mitigating a broad spectrum of financial risks, ensuring adherence to stringent regulatory frameworks and internal policies. This includes developing and implementing robust risk management frameworks, conducting comprehensive risk assessments, and monitoring key risk indicators. You will analyze financial data, market trends, and operational processes to detect potential vulnerabilities and propose effective mitigation strategies. The role requires a deep understanding of banking regulations, anti-money laundering (AML) requirements, know-your-customer (KYC) procedures, and capital adequacy directives. You will prepare detailed risk reports for senior management and regulatory bodies, ensuring clarity and accuracy. Collaboration with legal, compliance, and business units across the organization will be essential to foster a strong risk-aware culture. The ability to interpret complex regulatory documents and translate them into actionable business processes is crucial. You will also be involved in developing and delivering risk management training programs to employees. This is an exceptional opportunity for a seasoned risk professional to make a significant contribution to a leading financial services organization, working remotely from any location, but supporting operations connected to Bungoma, Bungoma, KE .
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8
Senior In-House Counsel - Regulatory Compliance
Posted 21 days ago
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Job Description
Our client, a rapidly expanding enterprise, is seeking a seasoned Senior In-House Counsel with extensive expertise in regulatory compliance to join their fully remote legal department. This critical role will involve advising on and ensuring adherence to a wide array of local and international regulations relevant to our client's operations. The successful candidate will be proactive in identifying potential compliance risks and developing robust strategies to mitigate them. This position requires a deep understanding of legal frameworks, excellent analytical skills, and the ability to communicate complex legal concepts to non-legal stakeholders.
Responsibilities:
Qualifications:
This is a fully remote opportunity, offering the flexibility to work from anywhere. Our client values diversity and inclusion.
Responsibilities:
- Develop, implement, and maintain comprehensive compliance programs across all business units.
- Interpret and advise on the application of relevant laws and regulations, including data privacy, consumer protection, anti-bribery, and industry-specific rules.
- Conduct regular compliance audits and risk assessments to identify areas of potential non-compliance.
- Develop and deliver compliance training programs for employees at all levels.
- Investigate compliance concerns and allegations of misconduct, recommending appropriate corrective actions.
- Liaise with regulatory authorities, government agencies, and external counsel on compliance matters.
- Draft and review corporate policies and procedures to ensure alignment with legal and regulatory requirements.
- Stay abreast of changes in the regulatory landscape and advise the business on their impact.
- Manage and oversee legal aspects of government investigations and inquiries.
- Contribute to the development of strategies to enhance the company's compliance culture.
- Provide legal support for new product launches and business initiatives, ensuring regulatory considerations are addressed.
- Maintain accurate records of compliance activities and regulatory filings.
Qualifications:
- Juris Doctor (J.D.) or equivalent law degree from an accredited institution.
- Active license to practice law in a relevant jurisdiction.
- Minimum of 7 years of experience practicing in regulatory compliance, corporate law, or as in-house counsel, preferably within a regulated industry.
- Demonstrated expertise in one or more key compliance areas (e.g., GDPR, CCPA, FCPA, KYC, AML).
- Proven experience in developing and implementing compliance programs.
- Excellent analytical, problem-solving, and risk management skills.
- Strong negotiation and advocacy abilities.
- Exceptional written and verbal communication skills, with the ability to explain complex legal issues clearly.
- Ability to work independently, manage a demanding workload, and prioritize effectively in a remote environment.
- Experience interacting with regulatory bodies is highly advantageous.
- High ethical standards and a commitment to professional integrity.
This is a fully remote opportunity, offering the flexibility to work from anywhere. Our client values diversity and inclusion.
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