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Director, Quality Assurance - Biologics

Director, Quality Assurance - Biologics
Company:

Catalent


Place:

Rizal


Job Function:

Human Resources

Details of the offer

Job Description

Position Overview:
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Yourtalents,ideasandpassionare essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent?Start here

Position Summary:
Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facilities in Bloomington, IN and Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.
The Role:
Catalent Bloomington has just commissioned a brand-new, state-of-theart facility with which includes a high-speed vial and syringe fill lines as well as line as well as a vial line, and we already have clients lined up to be the first customers, automated inspection and packaging lines. We are targeting the end of July to have this fully operational! Reporting into the Head of Quality for the Bloomington, Indiana site, the Director of QA, BLDG C will:

Manage asceptic Biologics manufacturing from a Quality perspective
Oversee a total organization of ~70
Provide leadership and direction through managers

Hold accountability for the performance and results of related disciplines
Execute functional business plans and contribute to the development of functional strategy for up to 6-18+ months in advance
Guide decisions by functional strategy and priorities
Interact with Clients and act as point of escalation for issues
Provide support for investigations
Oversee the Deviation leveling process
Manage and Develops the Quality Assurance Team
Serves as the Quality Assurance Subject Matter Expert for Prospective Clients

The Candidate:
Bachelor’s degree
Master’s degree preferred
10+ years GMP experience or other regulated industry
Must have significant exposure to Biologics products (minimum 3 years)
6 years providing quality assurance support to cGMP pharmaceutical production
8+ years of leadership experience

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 of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.
Visitwww.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, and confirming your request for an accommodation and include the job number, title and location toDisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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.


Source: Myworkdayjobs

Requirements

Director, Quality Assurance - Biologics
Company:

Catalent


Place:

Rizal


Job Function:

Human Resources

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