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Job ID 197711BR Position Title GCA Senior Compliance Officer Division CORPORATE Business Unit GROUP QA Country Switzerland Work Location Basel Company/Legal Entity Novartis International AG Functional Area Quality Job Type Full Time Employment Type Regular Job Description Is the senior-most compliance professional in the quality organization. Is a thought-leader providing expert advice and quality leadership to all Novartis units and functions. Provides governance and compliance leadership and oversight to Novartis across all business units/functions through risk-based system assessments relating to Health Authority Inspections, audits, compliance up-grade projects and ensures remediation activities are undertaken and implemented at all affected sites and functions, and verifies effectiveness. Designs, develops and leads implementation of compliance and inspection strategies and provides oversight governance and direction to the group members involved in inspections accordingly.
Works closely with the GCA Head of Compliance to design, development and globally implement risk-based, quality compliance related policies and oversight controls. Represents Novartis in enhanced interactions with the majority of major health authorities includ-ing the FDA and EMA, to promote corporate-wide GxP compliance. This includes the exchange of knowledge within Novartis in preparation for health authority/compliance inspections to prevent a disconnect relating to the correct interpretation of GxP regulations, agency expectations and regu-latory requirements across the Novartis network. Sets direction for the development of strategies and provides guidance and leadership to ensure that key compliance issues are addressed internally within Novartis by working collaboratively across all functional and geographic boundaries. Leads the Novartis Compliance Alert process across all units at Novartis, to ensure significant compliance issues and events get communicated to all relevant units and are adequately ad-dressed. Reviews GxP regulations and guidance circulated for comments by major health authorities, and assists in aligning functional groups to come together in developing comments focused on provid-ing a single Novartis position especially for hot topic/ high-risk issues. Manages and oversees the company wide Inspection Readiness Program. Provides leadership and oversight for major health authority inspections; reviews and adds global input to inspection responses and corrective action plans to ensure consistency and appropriateness of commitments in collaboration with Functional QA units as assigned. Determines cross-functional impact and co-ordinates cross-functional corrective action plans. Develops the strategy and direction and reviews final company (i.e. site, business unit, functional unit and division) official responses to major Health Authorities which completely address actions being taken to correct inspectional observations. Provides expert advice to ensure consistency with company-wide responses to assure there is no disconnect regarding the approach to commit-ted corrective actions and quality commitments among sites, business units and Divisions. Represents Group Quality on escalations of quality and compliance concerns in cases of critical observations and supports immediate follow-up measures according to the Novartis Quality Manual.
• Successful inspection and project outcomes
• Identification and mitigation of potential risks
• Compliance alerts issued for all significant events and trends Minimum requirements Graduate degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science
Excellent oral and written English communication skills. Second language is preferred.
15 years broad experience in Pharmaceutical Industry or a related regulated industry.
Thought-leader in quality compliance in one or more GxP disciplines.
Broad business awareness.
Proven FDA experience in a quality audit, compliance role, or a former investigator to lead assessments in accordance with FDA QS standards or proven European HA experience in quality audit, compliance role, or a former inspector to lead assessments in accordance with EU pharmacovigilance standards.
Proven experience in compliance related remediations, working knowledge of the GxP quality management concepts, risk management techniques.
Prior experience as a regulator beneficial.
Excellent written and oral communication skills.