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Piramal Pharma Solutions is seeking a QA Team Leader to play a pivotal role in shaping and governing the Pharmaceutical Quality System (PQS) at our Grangemouth site. This role goes beyond routine compliance — it’s about quality leadership, risk-based decision making, and continuous improvement in a fast-paced clinical manufacturing environment. You will provide quality oversight for Antibody–Drug Conjugate (ADC) and other bioconjugate drug substances/products in clinical activities, ensuring regulatory readiness while partnering with site functions to embed quality into day-to-day operations. This role is ideal for a QA leader who thrives in collaboration, governance, and proactive quality improvement. Responsibilities 🏛️ Quality Governance & Systems Leadership 🔹 Lead governance of key PQS elements including Quality Management Reviews, PQRs, Vendor Qualification, and Audits (self-inspections, vendor, and customer audits) 🔹 Act as site system owner for TrackWise, ensuring effective and compliant use of the electronic QMS 🔹 Maintain and manage site regulatory registrations, licenses, and certifications 🔹 Serve as a Single Point of Contact between site QA and Corporate Quality (as delegated by the QA Manager) 🧪 Clinical & GxP Quality Oversight 🔹 Ensure site and functional compliance with UK/EU/US GMP/GDP, ICH, and other applicable regional guidance 🔹 Provide QA leadership supporting clinical ADC manufacturing, focusing on risk-based quality decisions rather than checkbox compliance 🔹 Identify, analyse, and communicate GxP trends, supporting proactive risk management and mitigation plans 🔹 Track regulatory intelligence and inspection trends to support inspection readiness 📊 Continuous Improvement & Metrics 🔹 Coordinate and report Quality Compliance KPIs and metrics to key stakeholders 🔹 Drive site-wide initiatives to reduce out-of-compliance events and improve right-first-time performance 🔹 Support and lead quality system and compliance improvement projects 🧠 Investigations, Audits & Training 🔹 Support quality investigations and ensure development of robust, effective CAPAs 🔹 Lead and support pre-audit preparation, audit hosting, and post-audit follow-up for customers and regulators 🔹 Coordinate and oversee QMS and GxP training, ensuring regulatory alignment and site engagement 🔹 Lead Quality Management Review meetings, clearly highlighting risks, actions, and improvement opportunities ✅ What We’re Looking For ✔️ Strong QA leadership experience in clinical-stage GMP environments (ADC or sterile/biologics experience highly desirable) ✔️ Deep understanding of PQS, risk management, and quality governance ✔️ Proven ability to influence cross-functional teams and embed quality culture ✔️ Experience working with electronic QMS systems (TrackWise preferred) ✔️ Confident communicator who can balance compliance, pragmatism, and business needs ✔️ Passion for continuous improvement and modern quality thinking

Contamination Control Manager (Biologics CDMO) At SRG, we are excited to be partnering with our client, a biologics Contract Development and Manufacturing Organisation (CDMO), to appoint an experienced Contamination Control Manager. This is a senior, high-impact role for a contamination control leader who combines deep technical expertise with strong on-the-floor influence, embedding contamination control into systems, behaviours, and decision-making across a multi-facility, multi-client manufacturing environment. The Opportunity You will lead, develop and continuously enhance an established, integrated Contamination Control Strategy (CCS), ensuring it remains dynamic, risk-based and aligned with evolving business needs, regulatory expectations, and future-state technologies. Working closely with Manufacturing, MSAT and Quality, you will proactively identify, reduce and eliminate contamination risks across facilities, client products and processes, while maintaining inspection readiness and client confidence. Key Responsibilities Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations. Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes. Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development. Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction. Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness. Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers. Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends. Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement. Champion a strong site-wide contamination control culture where prevention is everyone's responsibility. Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations. Act as the contamination control SME during client audits and regulatory inspections. Candidate Profile Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred). Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO. Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control. Proven experience leading FMEA and cross-functional risk assessments. Solid understanding of global regulatory expectations. Ability to influence in matrixed environments with strong communication, coaching and facilitation skills. Desirable Experience Hands-on involvement with EU GMP Annex 1 implementation. Experience supporting tech transfer into commercial manufacturing. Regulatory inspection and client audit readiness experience. Background in facilities operating shared equipment or campaign manufacturing. What Success Looks Like Reduction in contamination events and repeat deviations. A clear, inspection-ready CCS understood across the site. Consistent aseptic behaviours across shifts and products. Strong client confidence and positive audit outcomes. Contamination control embedded into everyday operations, not managed by exception. What you can expect in return Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme. A chance to make a real difference and lead from the front in a key role on site Working at the forefront of the biologics industryGuidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy