External Quality Assurance Manager
Pharmanovia · Breda, Netherlands · hybrid
External Quality Assurance Manager - The Netherlands - Hybrid, 3 days in the office with two days working from home
We are seeking an External Quality Assurance Manager to oversee quality and compliance across our external manufacturing and supply network. You will build strong relationships with Contract Manufacturing Organisations (CMOs), suppliers, and other external partners, ensuring products are manufactured, tested, stored, and distributed in line with applicable regulatory requirements and company quality standards. Working cross-functionally, you will provide quality oversight throughout the product lifecycle, manage audits and quality events, support regulatory inspections and drive continuous improvement to protect product quality and patient safety.
External Quality Assurance Manager - Key responsibilities (quality oversight of external manufacturers, laboratories, suppliers, distributors and other third-party service providers).Key responsibilities- Provide quality oversight of external manufacturers, laboratories, suppliers, distributors and other third-party service providers.
- Establish and maintain effective quality relationships with external partners, set clear expectations, and promote a culture of compliance and continuous improvement.
- Plan and conduct risk-based audits of external partners, including preparation, reporting, follow-up and verification of corrective and preventive actions (CAPAs).
- Review and approve quality agreements, ensuring responsibilities and quality requirements are clearly defined and maintained.
- Assess and approve external partner changes, deviations, investigations, CAPAs and other quality records in accordance with company procedures.
- Oversee investigations into product quality complaints, non-conformances, batch issues and other quality events involving external partners.
- Review batch documentation and support batch disposition or release activities, where applicable to the role and delegated authority.
- Ensure external partners maintain appropriate controls for manufacturing, testing, packaging, storage and distribution of medicinal products.
- Support the qualification, onboarding, and ongoing monitoring of external partners, including assessing quality systems and compliance risks.
- Provide quality input into product transfers, new product introductions, acquisitions, divestments and other business projects involving external manufacturing.
- Support regulatory inspections and partner audits, coordinating responses and ensuring observations are addressed within agreed timeframes.
- Monitor external quality performance through relevant metrics and reports, identifying trends and escalating significant or recurring risks.
- Work with Supply Chain, Regulatory Affairs, Technical, Manufacturing, and other teams to resolve quality issues and maintain a continuous, compliant supply.
- Ensure quality documentation, records and systems are accurate, current and maintained in accordance with good documentation practices.
- Contribute to the development and maintenance of quality policies, procedures, guidance and training materials.
- Promote continuous improvement across external quality processes and support the implementation of effective, sustainable solutions.
- Escalate potential risks to product quality, patient safety or regulatory compliance promptly and through the appropriate channels.
Qualifications and professional attributes (education & operational excellence)Essential
- Degree in Pharmacy, Life Sciences, Chemistry or a related discipline, or equivalent relevant experience in pharmaceutical quality assurance.
- Substantial experience in pharmaceutical quality assurance, including oversight of external manufacturers or suppliers.
- Working knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and applicable UK and international pharmaceutical regulations.
Preferred
- Postgraduate qualification or professional certification in quality, pharmaceutical sciences or a related field.
- Experience supporting regulatory inspections and audits of pharmaceutical manufacturers and service providers.
- Experience with quality management systems and electronic quality management tools.
Required Skills
- Strong understanding of pharmaceutical quality systems, including deviations, investigations, CAPAs, change control, complaints and supplier qualification.
- Experience planning, conducting or managing GMP audits and assessing audit findings and corrective actions.
- Ability to interpret regulations, guidelines, and quality requirements and apply them to oversight of external partners.
- Excellent analytical and problem-solving skills, with the ability to assess risk, identify trends and recommend appropriate actions.
- Clear written and verbal communication skills, including the ability to prepare audit reports and quality documentation.
- Strong relationship-building and influencing skills, with confidence engaging constructively with external partners and internal stakeholders.
- Highly organised, with strong attention to detail and the ability to manage multiple priorities and deadlines.
- Proficient in Microsoft Office and comfortable using quality management systems and other relevant business systems.
- Professional judgement, integrity and a proactive approach to escalating quality or compliance concerns.
- Ability to work collaboratively across teams and geographies and support a culture focused on product quality and patient safety.
What we offer (benefits & career development)- Competitive salary and benefits package.
- Company pension scheme, private healthcare and life insurance.
- Generous holiday allowance and flexible working options where applicable.
- Professional development and training opportunities, including support for relevant qualifications.
- Opportunities to develop a career across quality, compliance and pharmaceutical operations.
- An inclusive workplace culture that emphasises well-being and work-life balance.
How to apply (application process & equal opportunities)Please submit your CV and a covering letter outlining your relevant pharmaceutical quality assurance experience and achievements. We are an equal opportunities employer and welcome applications from candidates of all backgrounds. Only shortlisted applicants will be contacted.