US-NJ, Director/Sr Compliance Professional Inspection Mgmt & Platform Support 225420BR-MZ
Director/Sr Compliance Professional Inspection Mgmt & Platform Support
Novartis Technical Operations
Provide governance, GMP compliance oversight and Quality Assurance compliance support to NTO/Platform/site health authority inspection readiness programs. Working within a matrix of the NTO platform structure, provide guidance and support for the platform sites using risk based system assessments of the operations, audits, compliance upgrade projects and inspection management. Assures remediation activities are undertaken and implemented at all affected sites and platforms, and verifies effectiveness. Support the NTO-Quality CIMA audit program, to the extent availability permits, by performing GMP audits.
Plan, perform and document, as lead or contributing auditor, routine and non-routine audits including compliance assessments, verifications audits, pre-approval/pre-submission project reviews, mock inspections of the various Novartis sites, organizations across all platforms and business units in accordance with the standards defined in the Novartis Quality Manual, the Novartis Audit Manual, NTO GOPs, and national/international GxP requirements.
Perform design review of audited / assessed processes to confirm capability to achieve the desired purpose and compliance with pertaining regulations and Novartis Quality Standards.
Assess the adequacy and approve, in collaboration with the responsible quality units, proposed corrective/preventative action plans. Verify implementation and effectiveness of CAPAs.
Provide training on audit, compliance and inspection techniques across Novartis. Contribute to and participate in the auditor certification program by training, mentoring, assessing and guiding NTO Platform auditors across the company.
Interact with regulatory authorities, such as the US FDA during compliance discussions, key inspections, and as part of the inspection management process.
For product filings with health authorities, provide guidance for timely remediation and recommendations regarding acceptability of the facilities, processes, and contents of the proposed filing.
Ensure appropriate escalation to responsible management in case of critical observations and support immediate follow-up measures according to Novartis Quality Manual.
Partner with sites/platforms as a NTO Quality - CIMA Liaison to ensure development of compliance strategy, including involvement with product escalation discussions associated with critical deviations, complaints, etc. and in the compliance information flow at the site level. Review all proposed regulatory correspondence.
Prepare organization and provide on-site support for key health authority inspections, input to responses and corrective action plans to ensure consistency and appropriateness of commitments.
Determine cross-platform impact and co-ordinate cross-platform corrective action plans.
**Travel: 50% minimum, international**
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelors degree in Chemistry, Pharmacy, Microbiology
English fluent in speaking and writing, 2nd language desirable
10 years broad experience in Pharmaceutical Industry or a related regulated industry. Valid operational experience includes quality management, QA operations, production, development or QC operations, or other relevant experience working at a regulatory health authority. Broad business awareness. Expertise in one or more of the following areas: Manufacturing of pharmaceutical API, drug products and medical devices, Facilities, Engineering, CSV, Laboratories, or Microbiology. Proven FDA experience in a quality audit, compliance role, or a former investigator to lead assessments in accordance with FDA QS standards. Proven experience in compliance related remediation, working knowledge of the GxPs quality management concepts, risk management techniques. Prior experience as a regulator beneficial. Experience in Microbiology, sterile products, aseptic techniques or solids products would be a preferred but not required. Excellent written and oral communication skills.
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