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