Head of Operational Quality and Formulation
Posted 1 week ago by Quantum Pharmaceutical Ltd
Negotiable
Undetermined
Undetermined
Burnopfield, England, United Kingdom
Summary: The Head of Operational Quality and Formulation at Target Healthcare Group is a pivotal role focused on overseeing the quality and formulation processes in the manufacturing of life-saving chemotherapy drugs. This position requires a strong background in pharmaceutical formulation and quality assurance, ensuring compliance with regulatory standards. The role emphasizes collaboration across various teams to enhance operational efficiency and product quality. It offers an opportunity to contribute significantly to healthcare innovation and patient safety.
Key Responsibilities:
- Oversee processes, policies, and quality teams for timely and safe product release in compliance with GMP and regulatory standards.
- Act as Quality Controller for the Burnopfield manufacturing site in line with MHRA requirements.
- Establish and report on key quality metrics, including batch release timelines and Right-First-Time rates.
- Lead monthly performance reviews and contribute to site-level Quality Manager Review forums.
- Identify bottlenecks and lead initiatives to streamline batch documentation and reduce release cycle time.
- Manage new product introduction from technical feasibility to production readiness.
- Liaise with production and procurement teams regarding new starting materials and formulations.
- Design and oversee stability programs in alignment with regulatory requirements.
- Lead deviation investigations, customer complaint assessments, and maintain compliance with GMP and MHRA regulations.
- Support audits and contribute to product recalls and Quality Management System reviews.
Key Skills:
- GPhC registration is essential.
- Minimum 5 years' experience in pharmaceutical formulation, QA, or manufacturing.
- Strong knowledge of GMP, GDP, and MHRA Specials guidance.
- Excellent communication, leadership, and project coordination skills.
- Strong data analysis and process improvement mindset.
- Experience in fast-paced, regulated, multi-site environments.
- Desirable experience in a similar role.
Salary (Rate): undetermined
City: Burnopfield
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Information Job Ref: JM1381015QuaHOOQAF
Location: Quantum House, Hobson Industrial Estate, Burnopfield Postcode: NE16 6EA
Type of contract: Permanent
Posted Date: Friday, August 22, 2025
Closing Date: Friday, September 19, 2025
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Head of Operational Quality and Formulation
Are you looking for a rewarding career in healthcare manufacturing? Join Target Healthcare Group , a pioneering pharmaceutical developer and manufacturer dedicated to innovation and saving lives. As part of our Group, Quantum Pharmaceutical is the UK’s leading manufacturer and supplier of unlicensed medicines and hard-to-source products. With over 500 professionals across various disciplines—including pharmacists, technicians, IT, HR, procurement, warehouse, and customer service—we are one of the fastest-growing healthcare companies in the UK .
We are currently seeking a passionate Head of Operational Quality and Formulation to join our Aseptic Services team , a key part of our operations, where we manufacture life-saving chemotherapy drugs .
Why This Role Matters
This isn’t just a job—it’s an opportunity to make a real difference . You’ll be part of a team that values growth, innovation, and professional development .
Your Responsibilities
- Product Release
- Overseeing processes, policies and quality teams to ensure timely and safe release of manufactured products in compliance with GMP, internal SOPs and regulatory standards.
- Act as Quality Controller on the Manufacturers Specials License for the Burnopfield manufacturing site in line with MHRA requirements
- Establish, monitor and report on key quality related release metrics including: Batch release timelines and adherence t SLA. Right-First-Time (RFT) release rates. Turnarund time for resolution of batch release issues.
- Lead mnthly performance reviews and contribute to site-level Quality Manager Review (QMR) forums.
- Identify bttlenecks and lead initiatives to streamline batch documentation, review workflows and reduce release cycle time.
- Implement and track cntinuous improvement projects using structured methodologies.
- Cllaborate with Production, Warehouse, training and QA to improve coordination and reduce repeat errors.
- Formulation and Product Introduction
- Manage and guide new product introduction from technical feasibility to production readiness.
- Liaise with production and procurement teams to assess and control new starting materials and formulations.
- Act as a Superuser for the electronic manufacturing system to ensure formulations are developed and manufactured according to GMP, internal SOPs and regulatory standards
- Stability and Lifecycle
- Design and oversee stability programs in alignment with regulatory requirements
- Own and monitor product lifecycle data.
- Lead root cause investigations and implement CAPAs related to formulation and product performance
- Ensure pharmacovigilance systems are in place and monitor adherence.
- Quality Systems and Compliance
- Lead deviation investigations, customer complaint assessments, risk assessments and change controls as required.
- Maintain and update SOPs, protocols and technical documentation
- Ensure compliance with GMP, GDP and MHRA Regulations
- Support audits and contribute to PQRs, product recalls and QMS reviews.
What We’re Looking For
- GPhC registration is essential.
- Minimum 5 years' experience in pharmaceutical formulation, QA, or manufacturing.
- Strong knowledge of GMP, GDP, and MHRA Specials guidance.
- Excellent communication, leadership, and project coordination skills.
- Strong data analysis and process improvement mindset.
- Comfortable working in fast-paced, regulated, multi-site environments.
- Experience of operating in a similar role is desirable.
Why Join Us?
- Career Growth - Elevate your expertise in a fast-growing, cutting-edge industry
- Flexible Shifts – Between our 24-hour core operating hours, Monday – Sunday
- Pension & Benefits – Including a cycle-to-work scheme
- Free Food & Drinks – Enjoy complimentary refreshments at work
- Vibrant Work Culture – A strong Social Committee organises regular events