Senior Quality Assurance Manager
- United Kingdom
- Permanent
- Full-time
- Lead and mentor a QA team, fostering a culture of quality and continuous improvement while providing expertise in QA, GMP, GDP, and regulatory compliance.
- Oversee and manage external inspections (authority and customer) and audits of suppliers, ensuring compliance with EU regulations and directives.
- Provide strategic guidance and quality expertise to cross-functional teams involved in product development, production, and supply chain.
- Drive risk management initiatives, ensuring robust oversight of Contract Management Organisations and cold storage requirements for pharmaceutical products.
- Support due diligence processes and new product launches, ensuring alignment with quality standards and regulatory requirements.
- Act as a role model by taking ownership of responsibilities, being transparent, and driving continuous improvement initiatives across departments.
- Collaborate with stakeholders to align QA initiatives with business goals and organizational strategies
- Significant experience in Quality Assurance within a pharmaceutical environment, with at least 3 years in a manufacturing facility.
- Expert knowledge of EU regulations, directives, and guidance, particularly related to GMDP and other GxPs.
- Proven experience in team management, including leading, mentoring, and developing QA teams.
- Strong experience in external inspections, supplier audits, and Contract Management Organisation oversight.
- Demonstrated ability to provide strategic guidance and align QA initiatives with business goals.
- Pragmatic problem-solving skills, with the ability to make informed decisions under pressure.
- Inspirational leadership qualities, adaptability to change, and a focus on fostering strong relationships with stakeholders.
- Attention to detail, strong analytical skills, and a results-oriented mindset with a passion for quality and continuous improvement