Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The role
We’re looking for an office‑based Senior QA Specialist to support our Supplier Management Programme, overseeing supplier audits, quality agreements, and compliance documentation. You’ll manage vendor‑related assessments, provide global vendor metrics, and author Product Quality Reviews.
This role suits someone with strong technical and regulatory knowledge, excellent attention to detail, and the confidence to work independently while influencing across teams.
Main responsibilities
* Manage the Supplier Management Programme, ensuring all processes are completed on time and in line with PCI procedures.
* Administer and update Nitrosamines Statements, Quality Agreements, TSE Statements, and Elemental Impurities Assessments.
* Schedule and perform supplier audits, ensuring follow‑up and CAPA completion.
* Author annual Product Quality Reviews (PQRs).
* Create and deliver training programmes for Vendor Management, Risk, and Audit modules in Master Control.
* Provide vendor management metrics and participate in global vendor management discussions.
* Ensure compliance with PCI SOPs, GMP, Health & Safety, and other regulatory requirements.
* Apply Quality Risk Management to identify, assess, and control risks effectively.
* Investigate deviations, errors, complaints, failures, and adverse events, ensuring appropriate documentation and corrective action.
* Work independently on key responsibilities while collaborating with the QMS Team Leader and colleagues.
* Support continuous improvement initiatives and identify opportunities to enhance quality processes.
* Uphold company values, demonstrating integrity, professionalism, and strong influencing skills across the organisation.
Requirements
Essential
* Experience in a Quality Assurance role.
* Previous experience in a Vendor Management role
* Previous experience conducting external supplier audits.
* Experience in a similar role in the pharmaceutical industry with up to date credentials relevant to both investigational (clinical trial) and marketed (commercial products).
* Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups.
* Proven ability and desire to continuously improve, by seeking new approaches and generating ideas.
* Proven ability to plan work effectively, by taking a long‑term view and developing structured action plans to meet business objectives.
* Must be able to effectively manage multiple tasks simultaneously.
* Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail
Desirable
* Experience in a Quality Assurance function
* Risk Management Experience
* PQR completion experience
* External Supplier audit experience
* Previous experience in a Vendor Management role
Benefits
At PCI, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well‑being and enhance your overall quality of life. Here's what we offer:
* Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
* Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
* Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
* Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
* Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!
* Staff Engagement: We value your dedication with recognition schemes and long‑service awards.
* Health and Well‑being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
* On‑Site Subsidized Canteen.
* Cycle to Work Scheme.
* Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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