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For Companies At a Glance
- Tasks: Lead quality governance and ensure compliance in a fast-paced clinical manufacturing environment.
- Company: Join Piramal Pharma Solutions, a leader in pharmaceutical quality systems.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Why this job: Shape the future of quality in pharma and drive continuous improvement.
- Qualifications: Strong QA leadership experience in clinical-stage GMP environments required.
- Other info: Collaborative culture with opportunities for professional development.
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)
- 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
- 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
- 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
Locations
QA Team Leader (Pharma) in Falkirk, 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 Falkirk, Grangemouth
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma industry, especially those who work at Piramal Pharma Solutions. A friendly chat can sometimes lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s values and recent projects. Show us that you’re not just another candidate; demonstrate how your QA leadership experience aligns with their mission of quality governance and continuous improvement.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you on their radar and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining the team at Piramal Pharma Solutions.
We think you need these skills to ace QA Team Leader (Pharma) in Falkirk, Grangemouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA Team Leader role. Highlight your experience in quality governance and risk management, especially in clinical-stage GMP environments. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to showcase your passion for continuous improvement and quality leadership. Tell us why you’re excited about the role and how you can contribute to our team at Piramal Pharma Solutions.
Showcase Your Achievements: Don’t just list your responsibilities; highlight your achievements! Share specific examples of how you've driven quality improvements or led successful audits. We love seeing quantifiable results that demonstrate your impact.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. Good luck!
How to prepare for a job interview at Piramal Pharma Solutions
✨Know Your PQS Inside Out
Make sure you have a solid understanding of the Pharmaceutical Quality System (PQS) and its key elements. Familiarise yourself with quality management reviews, vendor qualifications, and audits. This will show that you're not just compliant but also proactive about quality leadership.
✨Showcase Your Risk Management Skills
Prepare examples of how you've made risk-based decisions in previous roles. Be ready to discuss specific situations where your decisions led to improvements in quality or compliance. This will demonstrate your ability to think critically and lead effectively in a fast-paced environment.
✨Communicate Clearly and Confidently
Practice articulating your thoughts on quality governance and continuous improvement. Use clear, concise language and be prepared to balance compliance with business needs. This will help you convey your confidence and ability to influence cross-functional teams.
✨Emphasise Your Passion for Continuous Improvement
Share your enthusiasm for modern quality thinking and continuous improvement initiatives. Discuss any relevant projects you've led or participated in that resulted in measurable improvements. This will highlight your commitment to driving quality culture within the organisation.