Catalent Pharma Solutions Quality Assurance Manager in Woodstock, Illinois

Job Description

Position Summary

Catalent is looking to recruit a QA Manager to join a growing Quality team in Woodstock, IL.

The QA Manager will be instrumental in leading and managing two or more of the following functions within the Quality Organization including: Training, Document Review and Batch Release, QA Product Management, Customer Complaint, Internal Audit Activity, Supplier Audit, CAPA, Document Change Control, Management Review/KPI & Compliance Initiatives.

The Role

  • Define and manage the training, education, and development of the employees at the site, both directly and through staff members

  • Complete comprehensive review and assessment of Quality documents associated with the production and packaging of Blow/Fill/Seal (BFS) products for adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

  • Coordinate overall operations of the Catalent Quality Assurance function as related to individual products and customers – serve as analytical and technical QA resident expert

  • Complete comprehensive review and assessment of any complaints received regarding product quality allegation of or concerning a Catalent manufactured product that has been released to the market

  • Manage the overall development, implementation, and adherence to the Quality Systems including: CAPA, Change Control, Document Control, Document Issuance, and QMR

  • Manage the overall development, implementation, and maintenance of the Internal Audit program, Supplier Audit Program, and the Audit Hosting Program

The Candidate

  • Bachelor’s Degree in Science or Engineering preferred

  • Minimum of 4-6 years of relevant work experience in an FDA regulated environment, GMP pharma preferred; food or medical device industry experience may be considered

  • Experience hosting customer audits and regulatory inspections is highly preferred; must be able to field questions quickly and clearly from auditors and outside parties

  • Experience reviewing change controls and CAPAs required

  • Previous managerial experience required

  • Must possess impeccable writing skills and the ability & desire to be a hands-on manager

  • ASQ certification preferred

Position Benefits

  • Potential for career growth within an expanding Quality team

  • Defined career path and annual performance review & feedback process

  • Cross functional exposure to other areas of Quality and Production

  • Medical, Dental, Vision, and 401K are all offered from day one of employment

  • 19 days of paid time off annually + 7 paid holidays

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

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.