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- Tasks: Lead quality governance and ensure compliance in a fast-paced clinical manufacturing environment.
- Company: Piramal Pharma Solutions, a leader in pharmaceutical quality systems.
- Benefits: Competitive salary, career growth, and opportunities for continuous improvement.
- Why this job: Shape the future of quality in pharma and make a real impact on patient safety.
- Qualifications: Strong QA leadership experience in clinical-stage GMP environments required.
- Other info: Join a collaborative team focused on innovation and quality excellence.
The predicted salary is between 36000 - 60000 £ per year.
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
- 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
QA Team Leader (Pharma) in Grangemouth employer: Piramal Pharma Solutions
Contact Detail:
Piramal Pharma Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Team Leader (Pharma) in Grangemouth
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma industry, especially those who work in QA. A friendly chat can lead to insider info about job openings or even a referral that could get your foot in the door.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s values and recent projects. Show us you’re not just another candidate; demonstrate how your experience aligns with their mission and how you can contribute to their quality governance.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds and shows your proactive attitude.
✨Tip Number 4
Apply through our website! We love seeing applications directly from candidates who are genuinely interested in joining our team. Plus, it gives you a better chance to stand out in the crowd.
We think you need these skills to ace QA Team Leader (Pharma) in Grangemouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the QA Team Leader role. Highlight your leadership experience in clinical-stage GMP environments and any relevant projects you've led.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about quality governance and continuous improvement. Share specific examples of how you've influenced cross-functional teams and embedded a quality culture in your previous roles.
Showcase Your Technical Skills: Don’t forget to mention your experience with electronic QMS systems like TrackWise. We want to see how you’ve used these tools to enhance compliance and drive quality improvements in your past positions.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity at Piramal Pharma Solutions!
How to prepare for a job interview at Piramal Pharma Solutions
✨Know Your PQS Inside Out
Make sure you understand the Pharmaceutical Quality System (PQS) thoroughly. Familiarise yourself with its key elements, such as Quality Management Reviews and Vendor Qualification. This will help you demonstrate your expertise and show that you're ready to lead governance effectively.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led QA teams in clinical-stage GMP environments. Highlight your experience with risk-based decision making and how you've influenced cross-functional teams to embed a quality culture. This will illustrate your capability as a QA leader.
✨Be Ready for Compliance Questions
Expect questions about UK/EU/US GMP/GDP regulations and how they apply to the role. Brush up on recent inspection trends and regulatory intelligence, so you can discuss how you would ensure compliance and readiness at the Grangemouth site.
✨Emphasise Continuous Improvement
Demonstrate your passion for continuous improvement by discussing past initiatives you've led or been part of. Be specific about the metrics you used to track success and how you drove site-wide improvements. This will show that you're proactive and results-oriented.
