Job Description
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