Catalent Pharma Solutions Senior Quality Manager in Singapore

Job Description

Senior Quality Manager, Singapore

Position Summary

To provide quality oversight to the Clinical Storage and Distribution facility in Singapore in line with PIC/S Good Manufacturing Practice and Good Distribution Practice. (GMP and GDP)

The Role

  • Provide oversight and surveillance of overall site QMS to be align with Global or CSS network quality policies, standards and procedures

  • Provide support, guidance and advice on Quality matters to Project Management / Operations in clinical packaging, storage and distribution.

  • Host client audits, regulatory inspections and Corporate audits

  • Review and approval of Site Complaint, Deviation and Change Control reports.

  • Host Quarterly Site QMR (Quality Management Review) and escalate potential quality risks to global quality management.

  • Management of Site SOP system (including review, update and approval of local SOPs).

  • Review and approval Qualification/Validation Protocols and Reports.

  • Maintain and ensure the effective Site training system is in place

  • Ensure an effective Supplier Management System (including supplier evaluation and approval, periodical assessment and inspections) is maintained at site.

  • Approve or reject for incoming materials, bulk and finished products.

  • Review and approve Packaging Batch Records.

  • Perform duties as an Authorized Person - Pursuant to Annex 13 of PIC/S GMP Guide to Good Manufacturing Practice for Medicinal Product Part 1, assess and ensure that each batch has been manufactured and checked in accordance with standard of good manufacturing practice.

  • Ensure Quality Technical Agreements with Client / Project has been setup and implemented.

The Candidate

  • Degree / Diploma in Engineering / Quality

  • 15+ years’ experience in quality functions with 5+ years in a managerial supervisory position.

  • A robust track record in operational quality management and delivery in an environment of business development and change is essential.

  • An experienced people leader and manager with a track record of Quality Assurance.

Ability to demonstrate the Catalent leadership competencies

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

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, protected veteran status, sexual orientation or gender identity. 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.