Quality Specialist, DI & GxP Systems Compliance

Quality Specialist, Data Integrity & GxP Systems Compliance

Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates.  Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.

The Quality Specialist, Data Integrity & GxP Systems Compliance will support the CSV and Data Governance/Integrity programs as prescribed in corporate policies and site procedures across product lifecycles for assurance with regulatory and compliance requirements with GMP, Electronic Records and Electronic Signatures (ERES), and Data Integrity. The Quality Specialist, DI & GxP Systems Compliance will provide oversight for the governance; management and coordination of activities related to the Data Integrity Governance Program include directing, developing, and maintaining Data Integrity compliance across the site and internal functions in alignment with global GMP and ERES (FDA 21 CFR Part 11 and EMA Annex 11). Additionally, this position will ensure up to date application of modern CSV and compliance requirements applicable to computerized systems supporting Catalent GMP operations.

Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

• Enforce Computerized System Validation (CSV) guidelines, policies, and procedures for control systems, automation, analytical equipment, and IT applications. Ensuring that GxP systems comply with all applicable GxP, legal, and fiduciary policies, practices, and requirements.

• Collaborate with manufacturing, engineering, validation, information systems, QA, QC, and training to provide training and coaching on CSV projects and data integrity initiatives. Develop and execute plans, procedures, and requirements to address data integrity gaps for GxP systems and assuring compliance for the site.

• Identify data integrity risks and propose improvement plans.  This includes identifying data and systems issues, defining requirements, and recommending enhancements for system features and related processes.

• Assist in the development of site related data integrity training materials to provide guidance, training, and support to site personnel.

• Participate as DI SME in deviation management investigations, CAPA, and effectiveness check processes for continuous improvement and inspection readiness.  Assess changes to GxP systems and data integrity regulatory requirements and communicate requirements to site leadership.

• Review and approve change controls related to local GxP systems.

• Review and approve periodic reviews of local GxP systems.

• Collaborate on the maintenance of local policies and procedures.

• Perform other duties as assigned.  

The Candidate

• Bachelor’s degree is required, preferred in Computer Science, other STEM related field.

• 7+ years total relevant experience with 5+ years of Quality or IT role supporting GxP systems required.

• Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.

• Demonstrated experience and excellent knowledge of applicable CSV and IT regulations including the US FDA CFR’s, EU, ICH, as well as the GAMP guidance.