Overview
Catalent Bathgate, Scotland, United Kingdom is seeking a Senior Supplier Quality Specialist to join the Quality Network. This is a site-based role located in Bathgate, Scotland or Shorndorf, Germany.
Catalent Pharma Solutions 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 supports development programs and the launch of new products across pharma, biotech, and consumer health sectors, with a global network of sites.
Responsibilities
* 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-ups.
* 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 (e.g., 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 / Qualifications
* 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 essential.
* Ability to work independently and lead others with strong goal orientation and sense of responsibility.
* Experience and 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.
* Strong process improvement mindset, strategic business perspective and critical thinking capability.
* Demonstrate project management skills with the ability to prioritize, plan, evaluate and execute deliverables for established tactical goals.
* Strong follow-up skills and attention to detail.
* Ability to lead cross-functional teams.
* Competence in written and verbal communication; excellent English reading, writing and speaking skills.
* Influence and make recommendations at multiple levels of the company, and be decisive when required on product quality issues to ensure compliance.
* Located within a commutable distance to an international airport.
* Ability to travel domestically and internationally to Catalent sites or supplier locations as required (approximately 25% travel).
* This is a site-based position in Bathgate, Scotland or Shorndorf, Germany.
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Biotechnology Research and Pharmaceutical Manufacturing
Why 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. Access to private medical insurance, 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 LinkedIn Learning with 10,000+ online courses.
* Health & Wellbeing – Employee assistance programme, on-site canteen facilities, and an active safety culture. Join Employee Resource Groups that foster a diverse and inclusive workplace.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by email to DisabilityAccommodations@catalent.com and include the job number, title and location.
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