Deputy Director, Quality Risk and Performance - Vaccine
Swiftwater, Pennsylvania, Pearl River, New York
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Responsible for leading cross functional teams (including DDs/Managers/Shop floor) to perform proactive and reactive quality risk assessments in an efficient, cGMP compliant and safe manner.
Major responsibilities include effectively managing his/her team members to meet site Risk Management Program deliverables by providing framework for VIA-US Risk Champion program for proactive risk identification and technical guidance on test/production/facility issues as it relates to risk assessments and risk reporting category.
Deliver training on risk program and tools to ensure consistency in methodology on site and maintain training program to ensure it remains current with regulatory expectations.
Through risk assessment process, generate living risk assessments and approve associated reports for their assigned areas, track remediation of risks and elevate risks to local and senior management according to site procedures.
As needed, represent Director of Quality Risk Management at various Quality Forums (SQC, BPDR Review, GRRB, QRRB etc.).
Compliance: Provide leadership and guidance for creation of living Risk Assessments and associated Reports. Manage proactive and reactive risk assessment program for assigned areas. Execute Risk Champion program and training of team members in risk methodology and update program as needed. Actively participate and support internal and external inspections and observation responses. Review and Approve Area Risk Assessment/Reports.
Organizational and Operations Management: Provide leadership and guidance to VIA US operations (Swiftwater and Protein Sciences) as it relates to identified risks using site risk methodology. Responsible for maintain risk profile and routine updates to Management Committees. Provide strategic vision for responsible areas in alignment with site and global risk program. Ensure risk assessments/reviews in his/her area are scheduled efficiently to not impact production/testing scheduling while achieving the annual program requirements. Mentor and develop team members to achieve independent performance of site risk assessments, reports and annual reviews.
Technical Aptitude/Be SME for Risk Methodology: Conduct thorough risk assessments to identify key proactive and reactive risks for supply continuity assessments utilizing focused GEMBAs, prioritize and collaborate to develop remediation plans where required, and track status of risks to ensure global KPIs are met. Ensure Risk Reports meet all internal, global and regulatory requirements.
Leadership: Represent Director of Quality Risk Management at various Quality Forums (SQC, BPDR Review, GRRB, QRRB, etc.).
CONTEXT OF THE MAJOR CHALLENGES:
In this role, the incumbent will interact and collaborate with QRM counterparts across the Sanofi/Sanofi Pasteur Network predominantly through zoom conferences to support global initiatives and KPI tracking, as assigned.
Travel (approximately 10%) will be required to support Protein Sciences Pearl River, NY and Swiftwater, PA sites.
DIMENSIONS / SCOPE:
Breadth of responsibility (global/regional/country/site): Regional position supporting: VIA US (Protein Sciences, Meriden, CT, Pearl River, NY and Swiftwater, PA sites)
Key dimensions: headcount (direct and indirect) budget, doses, Capex…
Freedom to act, level of autonomy: The job holder is expected to work independently with a level of autonomy and authority for decisions related to risk assessments & RQNs.
This position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements and work environments.
It also requires to foster relationships with internal partners/customer (site functions) as well as external forums (CQC, GQA, QRM CoE) to achieve objectives.
Bachelor's Degree in a Scientific discipline.
A minimum 5 years’ experience in a cGMP controlled/pharmaceutical industry, including at least 5 years’ experience a regulated Quality environment
Excellent working knowledge of cGMPs (US, Canada, Japan, Europe), QRM, risk analysis tools and regulatory requirements
Minimum 2 years’ experience with Implementation of ICHQ9 standards and methodology.
Minimum 2 years’ experience in the site quality systems
Minimum 5 years' experience interacting with regulatory agencies and health authority inspections
Excellent organizational, interpersonal and leadership/teamwork abilities
A strong customer focus and ability to prioritize and adapt to business needs
Ability to coach other in QRM process.
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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