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.

Working knowledge of Project Management and Software Development Life Cycles. Familiarity with computer infrastructure, servers, workstations, Operating Systems and database
management systems.

Familiarity with computerized pharmaceutical GMP systems such as LIMS, CDS, BMS, JDE, SAP,
Analytical Instrumentation, Manufacturing and Packaging systems, Quality Management Systems, and their associated vendors.

Why You Should Join Catalent

Tuition Reimbursement – Let us help you finish your degree or earn a new one!

WellHub program to promote overall physical wellness.

152 hours of PTO + 8 paid holidays.

Medical, dental and vision benefits effective day one of employment. 

Defined career path and annual performance review and feedback process. 

Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

Dynamic, fast-paced work environment.

Positive working environment focusing on continually improving processes to remain innovative.

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. 

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

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. 

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 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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.