Deputy Director, Inspection and Audit Readiness - Vaccine
Pearl River, New York
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Responsible for the establishment and leadership of the Inspection and Audit Readiness program.
Ensure the site is always inspection and audit ready.
Manage regulatory body inspections, GQA, internal Site Self Inspection (SSI) program, and the process of responding to observations, CAPA creation/closure.
Responsible for issuing CAPAs for Post License Commitments (PLC).
Manage and publish site KPIs related to inspections, internal and corporate audits, and PLCs.
Responsible for the establishment and leadership of the Inspection and Audit program (internal and corporate) by ensuring a constant state of readiness.
Responsible for the coordination of regulatory body inspections, responses, CAPA creation, and follow-up.
Responsible to ensure executive management has clear visibility on the progress on regulatory body commitments
Site representative at the global inspection CoE.
Responsible for the PLC process.
Responsible for managing and publishing metrics for the site which are reported out locally, globally, and externally.
Builds and maintains a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments.
CONTEXT OF THE JOB/MAJOR CHALLENGES:
This position requires strong interpersonal skills to manage multiple and often conflicting priorities.
Must have strong leadership and negotiation skills to drive the remediation of identified deficiencies according to the scheduled commitment dates.
Must be able to work in a fast-paced environment.
Must be able to make balanced quality decisions.
Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization.
Must be able to think strategically.
DIMENSIONS / SCOPE:
Breadth of responsibility (global/regional/country/site):
Responsible for PSc Pearl River, NY and Meriden, CT sites with close interaction with Swiftwater, PA.
Will also link with Sanofi’s global forums, such as CoEs.
Financial dimensions: This position does not have budgetary responsibility and purchasing authority
Human Resources dimensions: This position does not have direct reports
This position is responsible for oversight of the preparation and execution of 2-3 Regulatory body inspections, and at least one Global Quality Audit each year.
Management of 15-20 Site Self Inspections per year.
Follow up of up to 50 regulatory and GQA audit commitments each year dependent on activity.
The individual must interact successfully within the highly energized production and regulatory environments.
The individual interacts regularly with regional counterparts on inter-site activities relating to inspection management and metric preparation and reporting.
The individual must be able to communicate clearly inspection risks and mitigation plans, cGMP requirements and site status on inspection preparation.
Freedom to act, autonomy in decision making
Bachelor's Degree in life sciences or a similar discipline.
A minimum 5 years’ experience in a cGMP controlled/pharmaceutical industry, including at least 5 years’ experience a regulated Quality environment.
Thorough knowledge of cGMPs and regulatory requirements.
Experience interacting with regulatory agencies and health authority inspections.
Excellent organizational, interpersonal and leadership/teamwork abilities are required.
A strong customer focus and ability to prioritize and adapt to business needs are required.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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