Associate Director, Quality Assurance
Position Summary
The Quality Assurance department plays a necessary role in the daily operations of the facility. The primary function of the department is to ensure compliance with FDA, EU and other regulatory agency requirements, as well as internal quality systems requirements for the Morrisville, NC facility. The quality group is responsible for project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material and finished-product release.
Requirements:
The Role
The Associate Director of Quality is responsible for site metrics, management review, and customer requested quality trending. He/she is responsible for review and evaluation of site compliance with RTP SOPs, as well as the overall direction, coordination, and evaluation of the quality unit.
•Develop and implement departmental plan, objectives and related procedures.
•Interface with all other departments to ensure compliance with cGLP/cGMP.
•Monitor site compliance to FDA, EU and all other applicable requirements.
•Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records.
•Ensure that all necessary QC testing is performed on manufactured products.
•Approve specifications, sampling instructions, test methods and other Quality Control procedures; to approve and monitor any contract analysts.
•Ensure that all required validation activities are completed.
•Ensure the required initial and continuing training is carried out and adapted according to need.
•Responsible for ensuring the environmental monitoring and control of the manufacturing environment and plant hygiene.
•Require approval and monitoring of suppliers of materials.
•Ensure the proper designation and monitoring of storage conditions for materials and products.
•Serve as site's secondary contact with both customers and regulatory agencies regarding quality/compliance issues.
•Analyze, resolve, or assist in solving compliance and customer issues.
•Ensure customer audits are managed for success and timely audit response letters.
•Manage a portion of the QA departmental budget.
•Recruit/hire QA management and staff.
•Manage staff who each supervise diverse groups of audit/document control staff.
•Ensure that GLP/GMP documentation is backed up by secondary media and archived appropriately.
•Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required.
•Stay informed regarding industry trends, interpretation of regulations and application to the RTP site.
The Candidate
•A minimum of a Bachelors degree in chemistry or closely related field combined with 10-12 years directly related experience
•Knowledge of cGMP, GLP, ICH, and USP regulations or guidelines
•Good understanding of the pharmaceutical industry and regulations applicable for a contract
•testing laboratory
•Knowledge of a production/technical field such as pharmaceutical analysis at various stages of
•product development
•Lead a group of 20-30 employees effectively
About Catalent (STANDARD " DO NOT EDIT!)
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.
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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.
