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Quality Assurance Manager
2 months ago
Overview
Essential Pharma is in search of a Quality Assurance Manager with extensive knowledge of Good Manufacturing Practices (GMP). This role involves overseeing the quality assurance operations associated with our subcontracted manufacturing processes, ensuring adherence to regulatory standards, and upholding exceptional product quality and safety. As the market authorization holder, you will be responsible for managing product-related quality incidents effectively.
Key Responsibilities
- Reporting to the Associate Director of QA – GMP Operations, you will contribute to the upkeep of the Quality Management System (QMS) in alignment with regulatory requirements (e.g., FDA, EMA, ICH).
- Ensure comprehensive documentation of all QA processes and procedures, guaranteeing they are adhered to and continuously enhanced.
- Conduct both internal and external audits and engage in regulatory inspections.
- Verify that all products meet applicable regulations and guidelines.
- Stay informed about changes in regulatory standards and ensure prompt adaptation to new requirements.
- Prepare for and participate in regulatory audits and inspections, including visits to Contract Manufacturing Organizations (CMOs).
- Oversee risk management, documentation, and reporting processes.
- Collaborate with cross-functional teams, including manufacturing, supply chain, MSAT, R&D, and regulatory affairs, to ensure product quality throughout its lifecycle.
- Promote continuous improvement and train teams on best practices within the quality domain across the organization.
Company Overview
Essential Pharma is a global specialty pharmaceutical organization committed to ensuring access to clinically distinct, niche medications for small patient populations. Our diverse portfolio encompasses over 300 products across ten therapeutic areas, focusing on central nervous system (CNS) disorders, gastroenterology, ophthalmology, and rare diseases. Our offerings serve patients in more than 70 countries.
We proactively identify low-volume, challenging-to-manufacture therapeutic products and late-stage clinical development assets targeting rare diseases. Our recent acquisition of Renaissance Pharmaceuticals marks a significant achievement for Essential Pharma, adding a second product for rare disease treatment and our first development-stage asset.
Qualifications
- A Bachelor's degree in Pharmaceutical Science, Biologics, Biotechnology, Biochemistry, or a related discipline.
- Demonstrated experience in quality assurance within the pharmaceutical sector, with essential experience in the manufacturing of medicinal products; experience with biological products is advantageous.
- In-depth understanding of Good Manufacturing Practices.
- Strong communication and interpersonal abilities.
- Capability to manage multiple projects and priorities in a dynamic environment.
- Certification in quality assurance (e.g., ASQ Certified Quality Manager) is preferred.
Benefits
- Competitive salary starting from £50,000.
- Flexible working arrangements, with the requirement to work at least two days per week from designated offices, depending on location.
- £150 reimbursement for home office expenses.
- Healthcare Insurance coverage.
- Pension plan with employee contributions of 5% and employer contributions of 3%.
- Life Insurance providing a tax-free death benefit of four times the basic salary.
- Enhanced family leave and sick pay provisions.
- Annual leave entitlement of 26 days plus public holidays, with additional time off during the holiday season.
- Discretionary annual performance bonus.
- Recognition program offering various incentives and awards.
Work Environment
We embrace flexible working arrangements, fostering an environment where individuals can express their authentic selves. Our values promote an inclusive culture where every voice is respected. We prioritize autonomy and responsibility while encouraging social interactions through various team-building activities. Our commitment to employee development is reflected in personalized growth plans, ensuring that everyone has the opportunity to excel.