Product Quality Manager Jobs

Product Quality Manager

Position Summary

The Product Quality Manager is responsible for ensuring effective and timely coordination of overall operations of the Catalent Quality Assurance functions as related to specific assigned products and customers. Serves as analytical and technical QA resident expert. Develops and supports departmental strategic goals for Catalent to assure the highest quality standards and regulatory compliance. The Product Quality Manager provides world class customer service, with the highest levels of integrity, focused on quality and compliance in partnership with Catalent-WIN customers and internal organizations. This position serves as a representative for their client(s) within the Catalent-WIN site.

The Role

• Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems.
• Responsible for maintaining systems and procedures to monitor the health of the quality system and show an awareness of their clients manufacturing floor areas audit readiness.
• Other duties as assigned.
• Interfaces with all other departments to ensure coordination and compliance with SOPs and cGMPs via observation of existing processes and implementation of continuous improvement initiatives.
• Interfaces with the Catalent Operations Groups and Customer Service departments as needed to communicate and maintain a partnership necessary for third-party manufacturing operations and ensure highest quality standards and regulatory compliance.
• Responsible for the maintenance, development and nurturing of the client partnership to ensure alignment and consensus.
• Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks. Specifically: reviewing and closure of investigations (major and minor deviations), reviewing and closure of non-critical customer complaints, reviewing executed batch records and support data, performing trending of product specific data, final disposition of batches, review and approval of Master Batch Records, review of site utility readings, review and approval of manufacturing calibration records, review and approve qualification reports, review of Quality Agreements, and author Annual Product Review/Annual Quality Review.
• Serves as NPI support member for products/processes as needed.
• Management of batch disposition team members.
• Responsible for supporting internal, client, and regulatory audits through coordination and/or leadership of the audit backroom.
• Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements.

The Candidate

• Experience working with third-party contract manufacturing in the Pharmaceutical industry preferred.
• Bachelor of Science in pharmaceutical applicable field; examples may include Science, Biology, Chemistry, or Engineering.
• Seven (7) years of experience in quality and/or regulatory in the Pharmaceutical industry.
• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Individual may be required to site for extended periods.
• Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 35 pounds.
• Occasional bending, grasping, carrying, stooping, kneeling, crouching
• Experience with managing people.
• Ability to enter manufacturing areas requiring full gowning (e.g., ability to bend, kneel, and stand on feet for long periods of time in a clean room or warehouse area).
• Demonstrated experience in successfully influencing others outside the incumbent’s department.

Why You Should Join 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 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.

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Catalent is an Equal Opportunity Employer, including disability and veterans.

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 [email protected]. 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.

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