2 Lead Pharmaceutical Quality Assurance Manager jobs in whatjobs

Lead Pharmaceutical Quality Assurance Manager

80100 Nairobi, Nairobi KES4800000 Annually WhatJobs

Posted 19 days ago

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Job Description

full-time
Our client, a globally recognized pharmaceutical company committed to improving health outcomes, is seeking a highly motivated and experienced Lead Pharmaceutical Quality Assurance Manager. This is a pivotal, fully remote role that will oversee the quality assurance functions across our client's diverse product lines. The successful candidate will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) in compliance with global regulatory standards (e.g., GMP, GDP, ICH guidelines). You will lead a team of QA professionals, ensuring adherence to strict quality protocols throughout the product lifecycle, from research and development to manufacturing and distribution. Key responsibilities include managing internal and external audits, conducting risk assessments, investigating deviations and out-of-specification results, and implementing corrective and preventive actions (CAPAs). The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control principles. You must have exceptional leadership skills, the ability to drive continuous improvement, and a meticulous attention to detail. This role demands strong analytical skills to interpret complex data, resolve quality issues, and make informed decisions that uphold the highest standards of product safety and efficacy. This is an excellent opportunity for a seasoned QA professional to make a significant impact in a remote-first environment, contributing to the development and delivery of life-saving medications. The work involves significant interaction with regulatory bodies and internal stakeholders, all managed remotely.

Responsibilities:
  • Lead and manage the Quality Assurance department, ensuring compliance with all relevant pharmaceutical regulations and standards.
  • Develop, implement, and maintain the company's Quality Management System (QMS).
  • Oversee all aspects of batch record review, product release, and stability testing programs.
  • Conduct internal audits and host regulatory inspections, ensuring all findings are addressed promptly.
  • Investigate deviations, customer complaints, and product quality issues, implementing effective CAPAs.
  • Manage the change control process and ensure that all changes are assessed for their impact on product quality.
  • Provide training and mentorship to QA staff.
  • Collaborate with R&D, manufacturing, and regulatory affairs to ensure product quality throughout its lifecycle.
  • Stay updated on evolving regulatory requirements and industry best practices.
Qualifications:
  • Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
  • Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance.
  • Extensive knowledge of cGMP, GDP, and ICH guidelines.
  • Proven experience in managing regulatory inspections and audits (e.g., FDA, EMA).
  • Strong leadership, team management, and interpersonal skills.
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Proficiency in quality risk management principles.
  • Exceptional written and verbal communication skills.
This role is based in **Mombasa, Mombasa, KE**, but operates as a fully remote position.
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Lead Pharmaceutical Quality Assurance Manager

80100 Nairobi, Nairobi KES400000 Annually WhatJobs

Posted 18 days ago

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Job Description

full-time
Our client is looking for a highly skilled and experienced Lead Pharmaceutical Quality Assurance Manager to oversee and enhance their quality management systems. This hybrid role requires a strategic thinker with a deep understanding of pharmaceutical regulations, manufacturing practices, and quality control principles. You will be responsible for developing, implementing, and maintaining robust QA policies and procedures to ensure compliance with global regulatory standards (e.g., GMP, ICH guidelines). Your duties will include conducting internal audits, managing external audits and inspections, investigating deviations and out-of-specification results, and implementing corrective and preventive actions (CAPAs). You will also lead and mentor a team of QA professionals, fostering a culture of quality and continuous improvement. Collaboration with various departments, including R&D, Manufacturing, and Regulatory Affairs, is essential to ensure product quality throughout the lifecycle. The ideal candidate will have excellent leadership, communication, and problem-solving skills. You will play a crucial role in risk management activities, change control processes, and batch release operations. This position offers a unique opportunity to shape the quality landscape of a growing pharmaceutical company, working both from a dedicated office space and remotely. You will be instrumental in ensuring the safety, efficacy, and quality of pharmaceutical products. A strong commitment to ethical practices and an unwavering focus on patient well-being are paramount. The role demands a proactive approach to identifying potential quality risks and implementing effective mitigation strategies. This is a key leadership position that offers significant responsibility and the chance to drive impactful changes within the organization. Your expertise will be vital in maintaining the integrity and reputation of our client's pharmaceutical offerings, ensuring they meet the highest industry benchmarks. We are seeking a dedicated professional ready to take on the challenges of ensuring pharmaceutical excellence in a dynamic environment.
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