Catalent Pharma Solutions Hiring for Quality Manager, GMP System Compliance at Morrisville, North Carolina Full Time

Quality Manager, GMP System Compliance

The Position

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. The Quality Manager, GMP System Compliance will support the laboratory systems compliance 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. You 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).

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 laboratory data integrity gaps for GxP systems and assuring compliance for the laboratories.

• Identifylaboratorydataintegrityrisksandproposeimprovementplans.Thisincludesidentifyingdataandsystems 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 SME in applicable deviation management investigations, CAPA, and effectiveness check processes for continuous improvement and inspection readiness.

• AssesschangestoGxPsystemsanddataintegrityregulatoryrequirementsandcommunicaterequirementstosite leadership.

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

• All other duties as assigned.

The Candidate

• Bachelor’s degree in Computer Science, Business Administration, other Science related field

• 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.

• 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.

• FamiliaritywithcomputerizedpharmaceuticalGMPsystemssuchasLIMS,CDS,BMS,JDE,SAP,Analytical Instrumentation, Manufacturing and Packaging systems, Quality Management Systems, and their associated vendors

• Appropriate leadership skills and behaviors aligned with Catalent competencies and values.

• Excellent written and verbal communication skills as well as good presentation skills.

• Ability to coordinate and work within cross-functional teams.

• Must demonstrate organizational skills and be able to interact with personnel at all levels within the organization from a variety of cultural backgrounds.

• Must be a self-starter, able to work independently and have ability to multi-task under strict deadlines.

• Detail orientated with ability to accomplish objectives through clear thinking and strong personal organizational 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.

Why You Should Work At Catalent

• Spearhead exciting and innovative projects

• Fast-paced, dynamic environment

• High visibility to members at all levels of the organization

• 152 hours of PTO + 8 paid holidays

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 (https://careers.catalent.com/us/en) 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 [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.

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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .