Manager Computer System Validation and Data Integrity Position Available In Somerset, New Jersey

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. Requires a Bachelor’s degree in Drug Regulatory Affairs and 3 years of experience in job offered or 3 years of experience as a Validation Analyst or any other job title performing all listed job duties.

Salary Range:

$118,200 to $206,900/year.

Apply online at https:

//www.catalent.com under Posting Number 0089310.