Manager, QA

Manager, QA (Product Development)

Position Summary

The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of the Quality Unit and could include all or some aspects of the Quality function.

The Product Development QA Manager provides quality focused customer service, with the highest integrity, in partnership with Catalent St. Petersburg's internal technical departments. This position is expected to serve as a representative for Catalent's strategic clients as well as support the clients with products that have technical opportunities for improvement. The QA Manager will act as an initial escalation decision maker within the quality organization. The QA Manager may oversee a staff from five to ten including Sr QA Technical Reviewers and QA Product Managers.

Responsible for ensuring the site is following cGMP guidelines, adherence to Catalent Corporate Quality Policies and applicable Catalent Pharma Solutions quality standards across the area of focus. Position requires partnership with other functional areas (e.g. Product Development, Operations, Customer Service, Validation, Quality Control, etc.) to ensure continued compliance for the area/site. Will provide directional support and as required, hands on, leadership to drive actions and enhancements to the QMS.

The QA Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated Master documents, including but not limited to Master Batch Records; Master Shipper Labels, Process recipes, various technical protocols (Pre-Commercial Clinical Packaging Protocols, Process assessment, Method Validation, Bulk Mfg Protocol and Reports (non-GMP, Clinical, Registration, Process Validation, Product Transfer, etc.), Risk Assessment, Formulation Reports, Development Reports, Material Evaluation Requests, Material and API Specifications; Product specifications; Test methods; b) RTE, Process improvement projects and Product Development Projects; c) Stability Protocols and cleaning validation documents; d) Deviations, Laboratory Investigations and other ad hoc documentation.

The Role

• Primary quality liaison for strategic clients and internal customers. In addition, the role is expected to take on existing clients/products that have opportunities for improvement. Is expected to become the Subject Matter Expert for the client products, processes and requirements and provide support in driving continuous improvement.
• Responsible for maintaining, developing, and nurturing 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.
• Bulk Mfg Protocols and Reports (non-GMP, Clinical, Registration, Process Validation, Product Transfer)
• Master Batch Records; and Master Shipper Labels.
• Change Control, as it pertains to the above validated/qualified systems and controlled documents
• Author and approval of deviations and laboratory investigations
• Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).
• Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production.
• Provide support to internal, client, and regulatory audits.
• Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times.
• Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.
• Potential to oversee and provide guidance to direct reports by:
• Assisting in performance management

The Candidate

• Bachelor's degree in science (Chemistry preferred) required or equivalent;
• A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience as QA in pharmaceutical industries.
• Prior experience working with quality control, manufacturing, product development preferred (Feasibility Batches, Clinical, Registration, Product Transfer)
• Proven ability to multi-task and demonstrate diplomatic skills.
• Must possess excellent English verbal and written communication skills.
• Proficient skills in Microsoft Office applications
• Working knowledge of cGMPs and/or OSHA regulations required.
• Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Why You Should Join Catalent

• 152 hours of PTO

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.

Visit Catalent Careers ) to explore career opportunities.

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 . 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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