3 Senior Pharmaceutical Quality Assurance Manager jobs in WhatJobs Direct
Senior Pharmaceutical Quality Assurance Manager
Posted 5 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company committed to innovation and quality, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager. This fully remote role is essential for ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and managing the Quality Management System (QMS), overseeing compliance with Good Manufacturing Practices (GMP), and leading quality assurance teams. The ideal candidate will possess extensive knowledge of pharmaceutical manufacturing processes, regulatory affairs, and quality control methodologies. Your expertise will be crucial in conducting internal audits, managing deviations and CAPAs, and ensuring the integrity of all quality-related documentation. Exceptional leadership, analytical skills, and the ability to communicate effectively with regulatory bodies and internal stakeholders in a virtual environment are paramount. If you are a dedicated QA professional passionate about ensuring the highest standards of pharmaceutical quality, we invite you to apply.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Ensure compliance with relevant pharmaceutical regulations and guidelines, including GMP, ICH, and local health authority requirements.
- Oversee and manage the quality assurance operations for pharmaceutical product development and manufacturing.
- Lead internal audits and support external regulatory inspections.
- Manage deviations, non-conformances, and corrective and preventive actions (CAPA) processes.
- Review and approve batch records, validation documents, and change controls.
- Train and mentor QA personnel.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality.
- Monitor quality metrics and key performance indicators (KPIs).
- Provide quality assurance expertise and guidance to cross-functional teams.
- Contribute to continuous improvement initiatives within the quality assurance function.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred.
- Minimum of 7 years of experience in pharmaceutical quality assurance, with at least 3 years in a managerial or supervisory role.
- In-depth knowledge of GMP, GDP, and other relevant pharmaceutical quality standards.
- Strong understanding of pharmaceutical manufacturing processes and regulatory requirements.
- Experience with validation activities, CAPA systems, and change control.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills, suitable for leading a remote team and interacting with regulatory bodies.
- Proficiency in using quality management software and tools.
- High level of attention to detail and commitment to quality.
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Senior Pharmaceutical Quality Assurance Manager
Posted 5 days ago
Job Viewed
Job Description
Our client, a rapidly growing pharmaceutical company, is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to oversee their quality operations in **Mombasa, Mombasa, KE**. This is a critical on-site role responsible for ensuring compliance with all relevant regulatory standards and maintaining the highest levels of product quality and safety.
The successful candidate will lead a team of QA professionals, implement and maintain robust quality management systems, and drive continuous improvement initiatives within the pharmaceutical manufacturing environment. You will be instrumental in preparing for and managing regulatory inspections, developing quality-related training programs, and ensuring that all processes adhere to Good Manufacturing Practices (GMP) and other applicable guidelines.
Responsibilities:
Qualifications:
The successful candidate will lead a team of QA professionals, implement and maintain robust quality management systems, and drive continuous improvement initiatives within the pharmaceutical manufacturing environment. You will be instrumental in preparing for and managing regulatory inspections, developing quality-related training programs, and ensuring that all processes adhere to Good Manufacturing Practices (GMP) and other applicable guidelines.
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with global regulatory requirements (e.g., FDA, EMA, WHO GMP).
- Lead and mentor the Quality Assurance team, providing guidance, training, and performance management.
- Oversee all QA activities, including batch record review, deviation management, CAPA implementation, change control, and OOS investigations.
- Conduct internal audits and coordinate external audits by regulatory agencies and customers.
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Manage the qualification and validation of equipment, processes, and facilities.
- Develop and deliver training programs on GMP, quality procedures, and other relevant topics.
- Review and approve manufacturing and laboratory documentation.
- Act as a key liaison with regulatory authorities during inspections.
- Drive continuous improvement initiatives to enhance product quality, process efficiency, and compliance.
- Manage product recalls and adverse event reporting as needed.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. A Master's degree is preferred.
- Minimum of 7 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in leading and managing a QA team.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent auditing, investigation, and problem-solving skills.
- Exceptional communication, interpersonal, and leadership abilities.
- Proficiency in quality management software and MS Office Suite.
- Ability to work under pressure and meet strict deadlines.
- Experience with dossier preparation and regulatory submissions is a plus.
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Senior Pharmaceutical Quality Assurance Manager
Posted 5 days ago
Job Viewed
Job Description
Our client, a leader in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to oversee and enhance their quality management systems. This is a critical, fully remote position requiring an individual with deep expertise in pharmaceutical regulations, quality control, and assurance processes. You will be responsible for ensuring that all products meet stringent quality standards and comply with global regulatory requirements, including GMP, FDA, and EMA guidelines. Your role will involve developing, implementing, and maintaining comprehensive quality assurance programs, policies, and procedures. This includes conducting internal audits, managing external audits, investigating deviations, and implementing corrective and preventive actions (CAPA). You will also play a key role in product lifecycle management, ensuring quality is integrated from R&D through to post-market surveillance. The ideal candidate will possess exceptional leadership skills, a meticulous attention to detail, and the ability to foster a strong quality culture within a remote setting. You will lead and mentor a team of quality professionals, driving continuous improvement initiatives across the organization. This position requires a proactive approach to identifying potential quality risks and implementing robust mitigation strategies. Collaboration with various departments, including R&D, manufacturing, regulatory affairs, and supply chain, is essential for success.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Ensure compliance with all relevant pharmaceutical regulations (GMP, FDA, EMA, etc.).
- Lead and conduct internal and external quality audits.
- Investigate quality deviations, out-of-specification (OOS) results, and customer complaints.
- Develop and manage Corrective and Preventive Actions (CAPA) plans.
- Oversee quality control processes for raw materials, in-process, and finished products.
- Review and approve batch records, validation protocols, and reports.
- Manage product lifecycle quality, from development to post-market.
- Lead and mentor the quality assurance team.
- Promote a culture of quality and continuous improvement throughout the organization.
- Liaise with regulatory agencies during inspections and inquiries.
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 10 years of experience in pharmaceutical quality assurance and quality control.
- Extensive knowledge of GMP, ICH guidelines, and global regulatory requirements.
- Proven experience in developing and managing QMS.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent leadership, communication, and interpersonal skills.
- Ability to conduct thorough investigations and implement effective CAPA.
- Experience with risk management principles and tools.
- Proficiency in quality management software is a plus.
- Demonstrated ability to work autonomously and lead teams in a remote environment.
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