Compliance Manager

1 month ago

Saint Petersburg, United States Catalent Pharma Solutions, Inc. Full time

Compliance Manager

Position Summary

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.

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.

Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects including but not limited to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations, Document Control, Equipment/Facilities, Change Control, 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 Role

* Enforce Computerized System Validation (CSV) guidelines, policies, and procedures for control systems, automation, analytical equipment, and IT applications.
* Ensure 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 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.
* Other duties as assigned

The Candidate

* Bachelor's degree in computer science, other STEM related field is required.
* In lieu of bachelor's degree, a minimum of 5 years of Quality or IT role supporting GxP systems and 7+ years total relevant experience will be considered.
* Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.
* Strong interpersonal, communication and problem-solving skills.
* Creative and innovative ability.
* Ability to work effectively under pressure and comply with timelines.
* Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
* Professional with strong interpersonal skills.
* Strong verbal and written communication skills; good presentation skills.
* Regularly applies theories and principles for one's technical discipline
* Works independently to solve problems of moderate scope
* Actively participates and suggests solutions to problems

Why You Should Catalent

* Competitive medical benefits and 401K
* 152 hours of PTO + 8 Paid Holidays
* Dynamic, fast-paced work environment
* Opportunity to work on Continuous Improvement Processes

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 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.

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