Supplier Quality Specialist

6 months ago

Bathgate, United Kingdom Catalent Full time

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

Catalent is a global, high growth, public company and leading partner for the pharmaceutical industry in the development and manufacturing of the new treatments for patients worldwide. Your talents, ideas, and passion is essential to our mission: to help people live better, healthier lives.

With nearly 25 years of experience, our Bathgate location in Scotland, UK is an integral part of Catalent’s European clinical supply services network. This 141,000 sq. ft. facility has a comprehensive range of capabilities to support sponsors’ studies throughout the UK, Europe and beyond, including clinical supply management, FastChain® demand-led supply, clinical-scale commercial packaging, and QP release services.

**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.
- Manage supplier complaints and liaise with suppliers to resolve supplier quality issues.
- Liaise with suppliers to ensure compliance to regulatory changes or updates (globally) and maintenance of valid licenses.
- Monitor supplier license renewal for applicable services.
- Perform expansion of service and new supplier requests
- 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.
- Participate and/or lead continuous improvement activities related to Global programs across the Catalent Global CSS network
- Negotiate supplier quality agreements
- Support Regulatory DSCSA process for US sites on the receipt of marketed drug Product
- Manage and conduct direct from manufacturer approvals for the Global Supplier Quality Management

**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 are preferred.
- 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
- Remote role with travel

**Why you should join Catalent**
- Competitive Salary
- Pension
- Holidays

**Catalent offers rewarding opportunities to further your career** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many

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