5 Lead Pharmaceutical Quality Assurance Manager Remote jobs in whatjobs
Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 21 days ago
Job Viewed
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.
This advertiser has chosen not to accept applicants from your region.
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Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 21 days ago
Job Viewed
Job Description
Our client is seeking a highly skilled and meticulous Lead Pharmaceutical Quality Assurance Manager to join their globally distributed, fully remote team. This critical role will be responsible for ensuring the highest standards of quality and compliance in all pharmaceutical processes and products. You will lead the development, implementation, and maintenance of robust quality management systems (QMS) in accordance with international regulatory guidelines (e.g., GMP, ICH). Your responsibilities will include conducting internal audits, managing external inspections, overseeing deviation investigations, and implementing corrective and preventive actions (CAPA). As a remote leader, you will excel at virtual collaboration, driving quality initiatives across different time zones, and fostering a strong quality culture within a distributed workforce. You will be instrumental in risk assessment and management, ensuring product safety and efficacy. The ideal candidate will have extensive experience in pharmaceutical quality assurance, a deep understanding of regulatory affairs, and a proven ability to lead and mentor quality professionals. Expertise in quality control testing, validation, and batch record review is essential. You will play a key role in the product lifecycle, from development to market release, ensuring all regulatory requirements are met. This is an exceptional opportunity to contribute to the development and manufacturing of life-saving medications from a remote setting. The ability to interpret and apply complex regulatory documents, troubleshoot quality issues, and drive continuous improvement is paramount. You will also be involved in supplier qualification and management. Strong analytical and problem-solving skills, coupled with excellent written and verbal communication abilities, are required. The **Meru, Meru, KE** region will be indirectly supported through the robust quality assurance framework you help establish and manage, even with the fully remote nature of this position. Your dedication to quality will directly impact patient safety.
This advertiser has chosen not to accept applicants from your region.
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Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 14 days ago
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Job Description
Our client is seeking a highly accomplished and detail-oriented Lead Pharmaceutical Quality Assurance Manager to join their team in a fully remote capacity. This critical role will be responsible for establishing, implementing, and maintaining robust quality management systems to ensure compliance with regulatory standards and industry best practices within the pharmaceutical sector. You will lead the QA team, providing strategic direction, mentorship, and oversight to all quality assurance activities, including audits, investigations, CAPA management, and change control. The ideal candidate will possess extensive experience in pharmaceutical quality assurance, with a deep understanding of cGMP, GCP, and other relevant regulatory guidelines (e.g., FDA, EMA). You will be instrumental in developing and executing QA strategies, ensuring the quality and integrity of pharmaceutical products throughout their lifecycle. Responsibilities include conducting internal and external audits, reviewing and approving batch records, and ensuring that all quality-related documentation is accurate and compliant. This remote position requires strong leadership skills, excellent analytical and problem-solving abilities, and the capacity to effectively manage and mentor a geographically dispersed team. Exceptional communication and interpersonal skills are essential for collaborating with various departments, regulatory agencies, and external partners. If you are a proactive leader committed to upholding the highest standards of quality in the pharmaceutical industry and are looking for a significant remote opportunity, we encourage you to apply. Your expertise will be vital in maintaining our client's commitment to product safety and efficacy. This role offers a unique chance to contribute to groundbreaking pharmaceutical advancements while working flexibly. You will be a key influencer in shaping QA policies and ensuring regulatory adherence across all operations.
This advertiser has chosen not to accept applicants from your region.
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Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 7 days ago
Job Viewed
Job Description
Our client, a rapidly expanding pharmaceutical company dedicated to producing high-quality medicines, is looking for a seasoned Lead Pharmaceutical Quality Assurance Manager for a fully remote position. This critical role ensures that all pharmaceutical products meet stringent regulatory standards and internal quality specifications throughout their lifecycle. You will be responsible for developing, implementing, and maintaining comprehensive Quality Management Systems (QMS) in compliance with global regulatory requirements (e.g., FDA, EMA, WHO). Your duties will include overseeing quality control processes, managing deviations and CAPAs, conducting internal audits, and ensuring the validation of manufacturing processes and equipment. You will lead a team of QA professionals, providing guidance, training, and performance management. Collaboration with manufacturing, R&D, and regulatory affairs departments is essential to foster a culture of quality across the organization. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific discipline, with significant experience in pharmaceutical quality assurance and regulatory affairs. In-depth knowledge of GMP (Good Manufacturing Practices), ICH guidelines, and pharmaceutical quality systems is mandatory. Strong leadership, analytical, and problem-solving skills are crucial. Excellent communication and interpersonal skills are necessary to effectively interact with internal teams and external regulatory bodies. This position offers the opportunity to significantly impact patient safety and product efficacy, working remotely to support operations relevant to areas like **Naivasha, Nakuru, KE**, and international markets.
This advertiser has chosen not to accept applicants from your region.
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Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 5 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company, is seeking an experienced and detail-oriented Lead Pharmaceutical Quality Assurance Manager to join their dedicated team. This is a fully remote position, offering the opportunity to oversee quality assurance processes from anywhere. The successful candidate will be instrumental in ensuring 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, conducting audits, managing deviations, and driving continuous improvement initiatives. Your expertise in GMP (Good Manufacturing Practices), GCP (Good Clinical Practices), and GXP regulations is essential.
Key Responsibilities:
Qualifications:
This role offers a competitive salary, comprehensive benefits, and the opportunity to shape quality standards in the pharmaceutical industry from the comfort of your home.
Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with global pharmaceutical regulations (e.g., FDA, EMA, WHO GMP).
- Oversee and manage all aspects of quality assurance for pharmaceutical products, from raw material sourcing to finished product release.
- Conduct internal and external audits of manufacturing facilities, suppliers, and contract manufacturers to ensure compliance with quality standards.
- Lead and manage the investigation of deviations, non-conformances, and CAPA (Corrective and Preventive Actions).
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Develop and deliver training programs on quality assurance principles and regulatory requirements.
- Monitor and analyze quality metrics and key performance indicators (KPIs) to identify trends and areas for improvement.
- Manage the change control process, ensuring that all changes are properly evaluated, documented, and approved.
- Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
- Collaborate effectively with cross-functional teams, including R&D, manufacturing, regulatory affairs, and clinical operations.
- Lead and mentor a team of Quality Assurance professionals.
- Prepare for and participate in regulatory inspections and client audits.
- Manage the qualification and validation of equipment, processes, and analytical methods.
- Oversee the handling of customer complaints and product recalls when necessary.
- Contribute to the development and maintenance of product quality reviews (PQRs).
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. A Master's degree or PhD is a plus.
- Minimum of 8 years of experience in pharmaceutical quality assurance or quality control, with a significant portion in a management or lead role.
- In-depth knowledge of GMP, GCP, GLP, and other relevant GXP regulations.
- Proven experience in developing and implementing QMS within the pharmaceutical industry.
- Strong understanding of pharmaceutical manufacturing processes, analytical testing, and validation.
- Excellent leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities, with meticulous attention to detail.
- Ability to work independently and manage multiple projects in a remote setting.
- Experience with regulatory agency inspections (e.g., FDA, EMA) and successful audit outcomes.
- Proficiency in quality risk management principles.
- Familiarity with pharmacovigilance principles is an advantage.
This role offers a competitive salary, comprehensive benefits, and the opportunity to shape quality standards in the pharmaceutical industry from the comfort of your home.
This advertiser has chosen not to accept applicants from your region.
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