Catalent Pharma Solutions Senior Manager, Quality in Bathgate, United Kingdom

Job Description

Senior Quality Manager

The role of the Senior Quality Manager is to be the face of Catalent Bathgate balancing our clients needs with strict regulatory compliance as well as hosting audits and regulatory inspections. As a Senior Quality Manager, you will be involved in every aspect of the quality function within the Bathgate site and part of a wider Quality function. The role of Senior Quality Manager will also offer the opportunity for international travel to other Catalent sites.

The Role

  • To develop, maintain and ensure compliance of the Quality Management system

  • Ensure professional fully trained Quality support is provided to all appropriate departments to allow timelines and deliverables to be met.

  • To identify quality improvements and enable improvements to be implemented in a compliant and controlled manner.

  • To guarantee the safety of product and people by working in compliance with the site rules and all Enviromental Health and Safety procedures.

  • Communication with all personnel at the site with regard to Good Manufacturing Practice (GMP), quality and regulatory issues.

  • Communication with clients manufacturing and testing sites regarding all aspects of batch release.

  • Communication with other Catalent sites regarding all aspects of quality and compliance and also quality improvement.

  • Disseminating information to the other Quality Personnel on ongoing issues.

  • Co-ordinate/organise Regulatory Inspections and client audits and follow up on recommendations to ensure requirements are all met.

  • Review and release Standard Operating Procedures, Pre and Post Packaging Batch Records, Material Specifications Randomisations Pre and Post Qualification documents for packaging equipment and observation and deviation reports

The Candidate

  • 5 years of relevant experience within a Quality or Senior Quality Manager role Demonstrable experience and sound knowledge of GMP regulations

  • Demonstrable leadership and organisational skills

  • Background in a production setting is preferable

  • Ability to interact with personnel at all levels from a variety of disciplines

  • Strong follow-up skills and attention to detail

  • Ability to be decisive regarding material/quality issues and work independently

Position Benefits

  • Competitive Salary

  • Bupa healthcare

  • Pension

  • Life Assurance

  • Free parking

  • Subsidised canteen

  • Range of corporate discounts

About Catalent

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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.