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