67 Senior Pharmaceutical Quality Assurance Manager Remote jobs in whatjobs
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 19 days ago
Job Viewed
Job Description
Senior Pharmaceutical Quality Assurance Manager - Remote
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain the Pharmaceutical Quality Management System (QMS).
- Ensure compliance with all relevant regulatory requirements, including cGMP, FDA, EMA, and local health authorities.
- Oversee quality control operations, including raw material testing, in-process testing, and finished product release.
- Manage internal and external audits, including preparation and follow-up.
- Investigate and document deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Review and approve batch records, validation protocols, and reports.
- Develop and implement quality training programs for personnel.
- Monitor product quality and identify trends, implementing appropriate corrective actions.
- Lead continuous improvement initiatives to enhance quality systems and processes.
- Manage supplier quality and conduct supplier audits.
- Stay current with evolving regulatory landscapes and industry best practices.
- Provide leadership and mentorship to the QA team.
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 20 days ago
Job Viewed
Job Description
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 19 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance (QA) systems and procedures in line with GMP and other relevant regulations.
- Lead internal and external audits of manufacturing sites, suppliers, and contract organizations.
- Manage and investigate deviations, out-of-specification (OOS) results, and customer complaints.
- Develop and implement Corrective and Preventive Actions (CAPAs) to address quality issues.
- Review and approve batch records, validation protocols, and reports.
- Ensure compliance with regulatory requirements from health authorities worldwide (e.g., FDA, EMA).
- Provide QA support for product development, manufacturing, and lifecycle management activities.
- Develop and deliver QA training programs to site personnel.
- Monitor quality metrics and provide reports on the state of quality to senior management.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- A minimum of 10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements for pharmaceuticals.
- Proven experience in leading audits, managing deviations, and implementing CAPAs.
- Strong understanding of pharmaceutical manufacturing processes, validation, and quality control.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with strong presentation abilities.
- Proven leadership and team management skills, with the ability to mentor staff.
- Demonstrated ability to work effectively in a remote, collaborative environment.
- Pharmaceutical quality certifications are a strong asset.
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 19 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain robust quality management systems (QMS) for pharmaceutical operations.
- Ensure compliance with global regulatory requirements, including GMP, GDP, and relevant health authority guidelines.
- Conduct and manage internal and external audits of manufacturing sites, suppliers, and partners.
- Oversee deviation investigations, root cause analysis, and the implementation of corrective and preventive actions (CAPA).
- Manage the change control process to ensure all changes are properly evaluated and implemented.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Develop and deliver quality assurance training programs to relevant personnel.
- Monitor and analyze quality metrics to identify trends and drive continuous improvement initiatives.
- Serve as a key point of contact for regulatory inspections and inquiries.
- Foster a strong quality culture throughout the organization.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in pharmaceutical quality assurance and quality control.
- Extensive knowledge of GMP, GLP, and other relevant pharmaceutical quality standards.
- Proven experience in managing quality systems, audits, and regulatory compliance.
- Strong understanding of pharmaceutical manufacturing processes and product development lifecycle.
- Experience with quality risk management and validation processes.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills.
- Ability to work independently and manage responsibilities effectively in a remote environment.
- Experience with electronic quality management systems (eQMS) is a plus.
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 20 days ago
Job Viewed
Job Description
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain robust Quality Management Systems (QMS) in accordance with relevant pharmaceutical regulations (e.g., GMP, ICH guidelines).
- Oversee all quality assurance activities, including batch record review, deviation management, change control, and CAPA.
- Conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to ensure compliance.
- Manage and mentor a remote team of QA professionals, fostering a culture of quality excellence.
- Collaborate with R&D, manufacturing, regulatory affairs, and other departments to ensure product quality and compliance.
- Lead regulatory inspections and respond to inquiries from health authorities.
- Analyze quality data, identify trends, and implement corrective and preventive actions (CAPA) to mitigate risks.
- Stay abreast of evolving pharmaceutical regulations and industry best practices, ensuring the company remains compliant.
- Review and approve critical quality documents, including SOPs, validation protocols, and batch release documentation.
- Drive continuous improvement initiatives to enhance product quality, process efficiency, and regulatory adherence.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 8 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of Good Manufacturing Practices (GMP) and international regulatory requirements.
- Proven experience in developing and implementing QMS, conducting audits, and managing deviations/CAPAs.
- Strong leadership, team management, and interpersonal skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Proficiency in utilizing electronic QMS software and other relevant digital tools.
- Exceptional written and verbal communication skills, with the ability to communicate complex quality concepts clearly.
- Ability to work independently, prioritize tasks, and manage multiple projects effectively in a remote setting.
- Experience interacting with regulatory agencies (e.g., FDA, EMA, KEBS) is essential.
Be The First To Know
About the latest Senior pharmaceutical quality assurance manager remote Jobs in Kenya !
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with pharmaceutical regulations.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
- Oversee and manage quality control processes for raw materials, in-process materials, and finished products.
- Conduct internal audits and manage external regulatory inspections.
- Lead and manage deviation investigations, root cause analysis, and CAPA implementation.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality and compliance.
- Provide quality assurance guidance and support to cross-functional teams.
- Manage supplier quality agreements and conduct supplier audits.
- Stay updated on evolving pharmaceutical regulations and quality best practices.
- Lead and mentor quality assurance personnel in a remote environment.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 8 years of progressive experience in pharmaceutical quality assurance and quality control.
- In-depth knowledge of GMP, GLP, and international pharmaceutical regulatory requirements.
- Proven experience in developing and implementing QMS.
- Strong understanding of pharmaceutical manufacturing processes and product development lifecycles.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional communication, interpersonal, and leadership skills, with experience managing remote teams.
- Proficiency in quality risk management principles and tools.
- Experience with validation processes (process, cleaning, analytical methods).
- Relevant certifications (e.g., CQPA, ASQ) are a plus.
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain a comprehensive Quality Management System (QMS) in compliance with global pharmaceutical regulations (e.g., FDA, EMA, WHO).
- Oversee and manage all aspects of Quality Assurance for pharmaceutical products, including raw materials, in-process testing, and finished goods.
- Conduct regular internal audits and facilitate external regulatory inspections, ensuring readiness and successful outcomes.
- Review and approve critical quality documents, including Batch Records, SOPs, validation protocols, and deviation reports.
- Manage the CAPA (Corrective and Preventive Actions) system, ensuring timely and effective resolution of quality issues.
- Lead investigations into product quality complaints and deviations, identifying root causes and implementing preventive measures.
- Develop and deliver training programs to ensure all personnel understand and adhere to quality standards and regulatory requirements.
- Monitor industry trends and regulatory updates, proactively adapting the QMS to maintain compliance.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure quality is integrated throughout the product lifecycle.
- Manage the supplier qualification program and ensure compliance of external suppliers.
- Contribute to the risk assessment process and develop mitigation strategies for quality-related risks.
- Lead and mentor a remote team of QA professionals, fostering a culture of quality excellence.
- Prepare and present quality metrics and reports to senior management.
- Ensure all activities comply with data integrity principles.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related Life Sciences field. A Ph.D. is a plus.
- Minimum of 10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of GMP, GLP, GCP, ICH guidelines, and other relevant international regulatory standards.
- Proven experience in developing and implementing robust Quality Management Systems.
- Demonstrated experience in leading regulatory inspections and audits.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent leadership, communication, problem-solving, and decision-making skills.
- Experience managing remote teams and working effectively in a distributed environment.
- Proficiency in quality risk management tools and techniques.
- Strong analytical skills and attention to detail.
- Ability to interpret and apply complex regulatory requirements.
- Experience with validation activities (process, cleaning, analytical methods).
This is a fully remote position offering a highly competitive salary, comprehensive benefits, and the opportunity to make a significant impact on patient safety and product quality within a leading pharmaceutical organization. If you are a driven QA professional seeking a challenging remote role, apply today.
Senior Pharmaceutical Quality Assurance Manager (Remote)
Posted 16 days ago
Job Viewed