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Director, Medical Device Quality

Company: Catalent
Location: Bloomington
Posted on: May 7, 2020

Job Description:

Job DescriptionPosition 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.-- Your talents, ideas and passion are 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 hereJob Title:-- Director, Medical Device Quality Location: Bloomington, INPosition Summary: A Director, Med Device Quality's primary duty is to maintain appropriate oversight of cGMP processes to ensure the quality of produced pharmaceutical and medical device products.-- Responsibilities include managing and monitoring quality assurance personnel systems, providing oversight for processes and facilities to ensure regulatory compliance in the manufacture of pharmaceutical products and medical devices, ensuring comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and cGMP test laboratories relating to raw material, in-process and product release, managing and monitoring final batch disposition of manufactured products and participating in investigations and corrective action identification and implementation process for OOS, OOT and Exceptions.--The Role: Provides leadership and direction through managers.Is accountable for the performance and results of related disciplines.--Executes functional business plans and contributes to the development of functional strategy for up to 6-18+ months in advance.--Decisions are guided by functional strategy and priorities.--Education and/or Experience: Bachelor's degreeMaster's degree preferred10+ years GMP experience or other regulated industry----6 years providing quality assurance support to cGMP pharmaceutical production or other regulated industry--8+ years of leadership experienceCatalent's standard leadership competencies that are used to interview and for Performance & Development:Leads with Integrity and RespectDelivers ResultsDemonstrates Business AcumenFosters Collaboration and TeamworkChampions ChangeEngages and InspiresCoaches and DevelopsCatalent 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.-- ---- --personal initiative. dynamic pace. meaningful work.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, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@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.

Keywords: Catalent, Bloomington , Director, Medical Device Quality, Healthcare , Bloomington, Indiana

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