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Senior Quality Manager
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Quality Operations Manager – Pharmaceutical Manufacturing
Midlands | Permanent | Site-Based
Allerton Bishop is partnering with a growing pharmaceutical healthcare organisation to appoint a Quality Operations Manager for its manufacturing operations in the Midlands.
This is a senior Quality leadership opportunity within an expanding GMP pharmaceutical manufacturing and compounding operation, with the business increasing its manufacturing footprint across two closely located sites.
Role Overview
Reporting to the Head of Quality, the Quality Operations Manager will lead across Operational Quality, Quality Management Systems (QMS) and Sterility Assurance, ensuring manufacturing and compounding activities consistently meet the required standards of GMP, product quality, patient safety and regulatory compliance.
The role will also lead and develop a team of Quality professionals, working closely with Manufacturing, Pharmacy, Technical and Engineering functions to strengthen Quality systems, improve operational performance and embed a proactive Quality culture across the sites.
Key Responsibilities
- Lead, manage and develop a team of Quality professionals across the manufacturing operation.
- Provide day-to-day Operational Quality leadership and GMP oversight across pharmaceutical manufacturing and compounding activities.
- Own and continuously improve key elements of the site's Pharmaceutical Quality System (PQS) and QMS.
- Ensure compliance with GMP, regulatory requirements, internal procedures and Quality standards.
- Provide Quality oversight of aseptic processing, sterile manufacturing and pharmaceutical compounding activities.
- Lead deviations, investigations, CAPAs, change controls and Quality Risk Management activities.
- Drive effective root cause investigations and sustainable corrective and preventative actions.
- Lead and support sterility assurance and contamination control activities.
- Monitor Quality performance through KPIs, metrics and trend analysis, identifying emerging risks and improvement opportunities.
- Support regulatory inspections, audits and ongoing inspection readiness.
- Partner with Manufacturing, Engineering, Technical and other functions on process changes, facility improvements and operational projects.
- Coach and develop Quality and operational teams, strengthening understanding of GMP and Quality requirements.
- Drive continuous improvement across Quality systems and operational processes.
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Candidate Profile
We are looking for an experienced pharmaceutical Quality professional who combines strong technical Quality knowledge with proven people leadership and operational Quality experience.
You will ideally bring:
- Significant Quality experience within sterile pharmaceutical manufacturing, aseptic processing, pharmaceutical compounding or a comparable GMP environment.
- Strong working knowledge of GMP and Pharmaceutical Quality Systems (PQS/QMS).
- Experience leading and developing a team of Quality professionals.
- Strong knowledge of deviations, CAPA, change control, investigations and Quality Risk Management.
- Experience supporting sterility assurance, contamination control and aseptic manufacturing activities.
- A practical, operational approach to Quality with the ability to work closely with Manufacturing and Technical teams.
- Strong communication and leadership skills with the ability to influence stakeholders at all levels.
- A continuous improvement mindset and the ability to strengthen Quality systems within a growing manufacturing environment.
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The Opportunity
This is an excellent opportunity to join an expanding pharmaceutical manufacturing organisation at an important stage of its development.
You will have significant influence over Quality Operations and QMS, lead an established Quality team and play a key role in supporting the continued growth and development of the organisation's Midlands manufacturing operations.
For a confidential discussion regarding this Quality Operations Manager opportunity in the Midlands, please contact Allerton Bishop.
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