Senior Supplier Quality Specialist

Catalent Pharma Solutions are looking to recruit a **Senior** **Supplier Quality Specialist** to join our team. The role will see you as an integral member of the Quality Network.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

**The Role**
- Manage the approved supplier list for Global Comparator, Depot and network site programs.
- Plan, conduct, review and report supplier site and questionnaire audits including third-party and outsourced audits for new and existing domestic and international suppliers in line with Network procedures.
- Ensure corrective action activities associated with all audit observations are agreed and completed in a timely manner.
- Complete and assist in completion of Supplier Quality Agreements, Supplier Audits, (questionnaire and site), Risk Assessments, Risk Control Plans, License Review, Change Controls, Actions and Follow-up’s.
- Ensure supplier records are current for all supplier approval documentation including audits, assessments, and quality agreements.
- Evaluate and manage new supplier requests through to completion
- Monitor supplier license renewal for applicable services.
- Perform impact assessments and execute action plans for supplier change notifications (i.e. facility change, supplier change controls)
- Evaluate supplier notifications for potential impact to internal processes and client commitments.
- Present concise and accurate information for queries on external audits as required
- Participate and/or lead continuous improvement activities related to Global programs across the Catalent Global CSS network

**The Person**
- A Bachelor’s Degree in a scientific or engineering discipline with some experience in pharmaceutical quality, or an equivalent combination of education and experience.
- Prior Supplier Auditing experience and experience in writing supplier audit reports, certified auditor or lead auditor credentials is essential.
- Ability to work independently and lead others with strong goal orientation and sense of responsibility.
- Experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution preferred.
- Prior experience in JDE and Trackwise systems preferred
- Ability to work independently with strong goal orientation and sense of responsibility.
- Strong process improvement mindset, strategic business perspective and critical thinking capability.
- Demonstrate project management skills with an ability to prioritize, plan, evaluate & execute deliverables for established tactical goals.
- Strong follow-up skills and attention to detail.
- Ability to lead cross-functional teams.
- Competence in both written and verbal communication.
- Excellent verbal and written communication and presentation skills with the ability to comprehensively read, write, and speak English.
- Influence and make recommendations at multiple levels of the company, be decisive when required on product quality issues to ensure compliance.
- Located within a commutable distance to International Airport.
- Ability to travel both domestic and abroad to Catalent sites or Catalent supplier locations as required ~25% travel
- This is a site based position in either Bathgate, Scotland or Shorndorf, Germany

**Why You Should Join Catalent**:

- ** Competitive Salary** - Reflecting your experience and skills.
- ** Bonus & Benefits** - Includes a site performance bonus, a pension scheme matching up to 7.5% and life assurance. Enjoy BUPA private medical insurance, a generous holiday entitlement that increases with tenure, and the option to trade leave.
- ** Career Development** - Access high-quality training, mentoring, and cross-functional opportunities within Catalent’s global network. Benefit from a subscription to LinkedIn Learning, providing access to 10,000+ online courses.
- ** Health & Wellbeing** - Includes an employee assistance programme, on-site canteen facilities, and an active safety and “Patient First” culture. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus, participate in charitable activities.
- ** Excellent Location** - Just a few minutes’ drive from J3A of the M8