Manager Computer System Validation and Data Integrity

INTERNET POSTING



Job Title: Manager Computer System Validation and Data Integrity City: Somerset

State : NJ

JOB DESCRIPTION :

Coordinate with project teams, suppliers, site quality and IT teams acting as an expert on quality, regulatory, and compliance resource, bringing forth opportunities for the implementation of new world-class systems and leverage existing systems for the assurance of GMP Manufacturing to help support the growth of the business; Provide quality and regulatory oversight of the design, development, validation, implementation and ongoing maintenance and use of computerized GxP systems and IT infrastructure; Oversee quality and regulatory assessments, change controls, periodic reviews, investigations, deviations and CAPAs relating to computerized GxP systems; Assure quality and regulatory compliance of global teams and sites; Provide quality and regulatory data integrity program management, oversight and training for global teams, systems and sites; Identify compliance and process improvements based upon internal and external audit observations and regulatory surveillance; Collaborate on the development and maintenance of Global Quality and CSV Polices, Standards and Procedures as well as participating in associated roll out and training; and Participate in internal and supplier audits as a compliance, IT and CSV subject matter expert and supporting regulatory and client audits of global systems and sites.

EDUCATION AND EXPERIENCE : Requires a Bachelor's degree in Drug Regulatory Affairs and 3 years of experience in job offered or 3 years of experience in the Related Occupation.

RELATED OCCUPATION:

Validation Analyst or any other job title performing all listed job duties.

JOB TIME : Full Time

SALARY RANGE: $118,200 to $206,900/year

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