QA Team Leader (Pharma)

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