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  Leads customer audits and coordinates site responses. Works with site area owners on implementation of audit related CAPAs

Responsible to report monthly site quality KPIs. Leads quality review board meetings and aides in creating action plans to maintain/improve quality KPIs

Responsible and accountable for the GxP electronic systems at the US JM Health locations, this includes but is not limited to coordination/execution of maintenance, back-up, restoration, optimization of existing systems and application of new modules and system updates. Serve as System Administrator for multiple GxP electronic systems and coordinate the activities of other System Administrators.

• Support creation and maintenance of the JM Data Integrity Program with special focus on the electronic data.
• Manages the creation and maintenance of JM Health global standards and SOPs for GxP electronic systems partnering with the various stakeholders, and supports their local deployment.
• Supports the implementation and maintenance of a harmonized approach to GxP data management, both paper and electronic, within JM Health sites.
• Develops changes or provides quality evaluation of change controls affecting validated GxP computerized systems for the US JM Health locations.
• Supports implementation of the changes or implementation of GxP electronic systems. This may include preparation or reviews/approval of user requirements, functional specifications, IQ/OQ/PQ protocols and reports for validation of computerized systems for GxP purposes, as required.
• Conducts sector audits for electronic and paper-based data management systems and data integrity and follow-up, supporting site remediation.
• May be required to support qualification, monitoring and external auditing program of suppliers and service providers.
• Actively participate to the preparation and execution of the inspection readiness and data integrity programs, as required. This may include execution of sector quality audits.
• Assists the Quality/Compliance functions at the US JM Health locations during inspections and customer audits in the area of GxP electronic systems and data integrity. This also includes preparation of responses, plan execution, monitoring progresses and following-up.
• Provide back-up support to Quality Operations and Compliance as needed.

BS in Chemistry or related science

7 to 10 years’ experience in the pharmaceutical manufacturing industry

1-2 years’ experience as Administrator of electronic platforms and associated requirements

Skills/Experience Valued but not required:

• Experience in a cGMP environment
• Experience or familiarity with Labware LIMS and the Instrument Manager module
• Experience or familiarity with Master Control and Trackwise
• Recent relevant experience in bulk pharmaceutical/API manufacturing or specialty chemicals
• This role has influence across multiple sites which may require travel within US and international travel (5-10%).

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.

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