At a Glance
- Tasks: Lead the Quality Assurance function in a dynamic pharmaceutical manufacturing environment.
- Company: Established pharmaceutical manufacturer with a focus on quality and compliance.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for professional growth.
- Other info: Join a senior leadership team and drive continuous improvement initiatives across operations.
- Why this job: Make a significant impact on quality culture and regulatory compliance in a strategic leadership role.
- Qualifications: Extensive QA leadership experience in GMP-regulated environments and strong knowledge of global quality standards.
The predicted salary is between 80000 - 100000 £ per year.
An established pharmaceutical manufacturer is seeking a Director of Quality Assurance to lead the QA function across a complex Oral Solid Dose (OSD) manufacturing operation. This is a strategic leadership position responsible for driving quality culture, regulatory compliance, inspection readiness, and continuous improvement while partnering with Manufacturing, Supply Chain, Technical Operations and senior site leadership.
The successful candidate will provide direction to multiple QA teams, ensuring products are manufactured in accordance with GMP requirements and global regulatory expectations.
- Provide strategic leadership for the site Quality Assurance function across OSD manufacturing operations.
- Lead and develop multiple QA teams, fostering a strong quality culture and high-performance environment.
- Ensure ongoing compliance with EU GMP, FDA and other applicable regulatory requirements.
- Maintain inspection readiness and lead regulatory inspections from agencies including FDA, MHRA and EMA.
- Oversee batch disposition processes and ensure robust quality decision-making.
- Drive continuous improvement initiatives across Quality Systems and manufacturing processes.
- Provide oversight of deviations, CAPAs, change controls, investigations and risk management activities.
- Partner closely with Manufacturing, MS&T, Engineering, Validation, QC and Supply Chain to support operational excellence.
- Review quality metrics and identify trends to proactively improve performance.
- Ensure effective implementation and maintenance of the site's Quality Management System (QMS).
- Support new product introductions, technology transfers and commercial manufacturing activities.
- Manage quality-related risks and ensure appropriate governance across the site.
- Act as a key member of the site leadership team, influencing business strategy from a quality perspective.
Qualifications:
- Degree in Pharmacy, Chemistry, Pharmaceutical Sciences or another relevant scientific discipline.
- Extensive Quality Assurance leadership experience within a GMP-regulated pharmaceutical manufacturing environment.
- Strong working knowledge of EU GMP, FDA regulations, ICH guidelines and global quality standards.
- Demonstrated experience leading regulatory inspections and managing audit responses.
- Proven ability to lead large multidisciplinary QA teams.
- Strong leadership, communication and stakeholder management skills.
- Strategic mindset with the ability to balance quality, compliance and business objectives.
- Experience within a multinational pharmaceutical manufacturing environment.
- Knowledge of digital quality systems and continuous improvement methodologies (Lean/Six Sigma).
Senior leadership opportunity within a highly regulated pharmaceutical manufacturing site. Opportunity to lead a well-established Quality organisation supporting complex OSD manufacturing. Competitive salary and comprehensive benefits package.
Senior Director - Quality Assurance in England employer: Thor
Join a leading pharmaceutical manufacturer as a Senior Director of Quality Assurance, where you will play a pivotal role in shaping the quality culture and ensuring compliance within a dynamic Oral Solid Dose manufacturing environment. Our company fosters a collaborative work culture that prioritises employee growth through continuous improvement initiatives and strategic leadership opportunities, all while offering a competitive salary and comprehensive benefits package. Located in a vibrant area, we provide a unique opportunity to influence business strategy and drive excellence in a highly regulated industry.
