1,969 Lead Pharmaceutical Quality Assurance Specialist jobs in Kenya
Lead Pharmaceutical Quality Assurance Specialist
Posted 21 days ago
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Job Description
Our client is seeking an accomplished Lead Pharmaceutical Quality Assurance Specialist to oversee and enhance their quality management systems, operating entirely remotely. This crucial role ensures that all pharmaceutical products and processes comply with stringent regulatory standards, internal policies, and customer requirements. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, conducting thorough audits, and leading investigations into deviations and non-conformities. The ideal candidate will possess a strong background in pharmaceutical sciences, quality control, or a related field, with extensive experience in GMP (Good Manufacturing Practices) and regulatory compliance. Responsibilities include managing quality documentation, coordinating quality review boards, and collaborating with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to drive quality initiatives. You will also be responsible for training and mentoring junior QA staff, fostering a culture of quality excellence throughout the organization. This position demands exceptional analytical and problem-solving skills, meticulous attention to detail, and outstanding communication and interpersonal abilities to effectively influence and collaborate in a remote setting. You will play a pivotal role in ensuring the safety, efficacy, and integrity of our pharmaceutical products, thereby safeguarding patient health and maintaining the company's reputation. Experience with pharmaceutical quality systems software and a thorough understanding of global regulatory requirements (FDA, EMA, etc.) are essential. This is an unparalleled opportunity for a dedicated QA professional to lead significant quality assurance efforts, drive continuous improvement, and contribute to the development of life-saving medicines in a challenging and rewarding remote role. If you are passionate about pharmaceutical quality and possess the leadership expertise to excel, we encourage you to apply.
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Lead Pharmaceutical Quality Assurance Specialist (Remote)
Posted 21 days ago
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Job Description
Our client is seeking a highly qualified and experienced Lead Pharmaceutical Quality Assurance Specialist to join their global remote team. This senior role will be instrumental in ensuring compliance with stringent pharmaceutical regulations and industry best practices across all quality assurance functions. You will lead and mentor a team of QA professionals, oversee the development and implementation of quality management systems, and drive continuous improvement initiatives. Key responsibilities include developing and executing quality assurance strategies, establishing QA policies and procedures, and ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulatory guidelines. You will be responsible for conducting internal audits, managing external regulatory inspections, and investigating deviations and CAPAs (Corrective and Preventive Actions). Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, is crucial to ensure product quality and integrity throughout the lifecycle. The ideal candidate will possess a deep understanding of the pharmaceutical industry, regulatory landscapes (FDA, EMA, etc.), and quality control principles. A proven track record in leading QA teams and managing complex QA projects is required. Excellent analytical, problem-solving, and decision-making skills are paramount. Strong communication and interpersonal skills are essential for effective team leadership and stakeholder engagement. This is a fully remote position, requiring a proactive, detail-oriented individual with the ability to work independently and manage multiple priorities effectively. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is mandatory. Extensive experience in pharmaceutical quality assurance is essential.
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Remote Lead Pharmaceutical Quality Assurance Specialist
Posted 10 days ago
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Job Description
Our client is seeking a highly meticulous and experienced Remote Lead Pharmaceutical Quality Assurance Specialist to join their robust, fully remote Quality Assurance department. This critical role is responsible for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. The ideal candidate will possess extensive knowledge of pharmaceutical manufacturing processes, regulatory guidelines (e.g., GMP, GDP), and quality management systems. You will lead a team of QA professionals, overseeing the implementation and continuous improvement of QA strategies and processes. Key responsibilities include developing and executing quality control plans, conducting internal audits, managing deviations and CAPAs (Corrective and Preventive Actions), and ensuring compliance with all relevant health authority regulations. The Lead QA Specialist will play a vital role in product lifecycle management, from raw material testing and in-process control to finished product release. Strong analytical skills, meticulous attention to detail, and excellent problem-solving abilities are essential for identifying and mitigating potential quality risks. The incumbent will also be responsible for training QA staff, collaborating with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs), and preparing documentation for regulatory submissions and inspections. This position offers a challenging and rewarding opportunity to contribute to patient safety and public health from a remote work setting. While this role is entirely remote, it directly supports and influences the quality control operations that are managed by our client's facilities in Eldoret, Uasin Gishu, KE .
Responsibilities:
Responsibilities:
- Lead the development, implementation, and maintenance of the Quality Management System (QMS).
- Ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulations.
- Oversee the investigation of deviations, out-of-specifications (OOS), and customer complaints.
- Manage Corrective and Preventive Actions (CAPA) implementation and effectiveness.
- Conduct internal audits and support external regulatory inspections.
- Review and approve batch records, validation reports, and other quality-related documents.
- Develop and implement quality control strategies and testing protocols.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality.
- Train and mentor junior QA personnel.
- Monitor industry trends and regulatory changes affecting pharmaceutical quality.
- Contribute to the continuous improvement of quality processes and systems.
- Manage supplier quality and qualification programs.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related science field.
- Minimum of 7 years of experience in Pharmaceutical Quality Assurance/Quality Control.
- Proven experience in a leadership or supervisory role within QA.
- In-depth knowledge of GMP/GDP regulations and guidelines.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Experience with QMS, deviation management, and CAPA systems.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills.
- Proficiency in quality documentation and regulatory submission support.
- Ability to work independently and effectively manage workload in a remote environment.
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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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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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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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