VP, Quality Assurance & Regulatory Compliance

VP, Quality Assurance & Regulatory Compliance

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At EVERSANA, we are proud to be certified as a Great Place to Work across the world. We’re fueled by our vision to create a healthier world. Our global team of more than 7,000 employees is committed to delivering next‑generation commercialization services to the life sciences industry. We serve more than 650 clients ranging from innovative biotech start‑ups to established pharmaceutical companies.

Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them.

The VP, Quality Assurance & Regulatory Compliance is responsible for establishing strategies, planning and development of quality and regulatory compliance processes and procedures, ensuring that EVERSANA is compliant with all applicable federal, state, and local regulations and standards, with a focus on Quality & Regulatory.

• Oversee Quality Assurance, setting quality goals and objectives consistent with business unit and management goals, FDA/DEA, State Boards Pharmacy, Accredited Bodies, GDP and ISO Quality Standards.
• Promote a company‑wide culture of quality awareness and understanding of the key elements related to the quality system and regulatory compliance requirements.
• Serve as the Quality Management Representative for regulators, notified bodies and customer audits.
• Maintain knowledge of existing and emerging quality standards, regulations and guidance documents; interpret changes and ensure they are communicated through corporate policies and Supplier Agreements.
• Support ownership of audit processes for Supplier Qualification and Maintenance; work cross‑functionally to facilitate Supplier Selection.
• Have extensive experience in the selection and qualification of GxP suppliers and the transfer of GxP responsibilities, and preparing, reviewing, and approving the corresponding quality agreements.
• Work with SMEs in specific disciplines to ensure expert technical review of controlled documents; review and approve controlled documentation related to GxP activities outsourced to Qualified Suppliers, including deviations, OOS investigations, CAPAs, risk assessments, etc.
• Create a quality documentation system by writing and updating quality assurance procedures.
• Support Qualified Suppliers in developing protocols for test method validations, design and process verifications and validations, biocompatibility, sterilization, shelf life, stability, and risk management to ensure compliance.
• Develop the Quality Assurance Unit by recruiting, selecting, orienting, and training QA staff.
• Ensure quality by planning, monitoring, and appraising job results.

• Drive implementation of and continued compliance with global regulatory requirements; interpret and apply pertinent laws and regulations governing company services to meet business objectives.
• Lead development, implementation, and maintenance of regulatory processes at the business level.
• Support the development of regulatory compliance strategies.
• Work with Business Unit Implementation Teams and/or commercial partners to plan, track, and align regulatory licensure submissions across all facilities.
• Serve as main Channel Management with Regulatory Authorities or, where appropriate, work with regulatory consultants or clients to ensure compliance.
• Demonstrate sound understanding of related fields (e.g., controlled substance and cold chain products quality assurance) and solve complex problems in collaboration with colleagues in other functions.
• Monitor the regulatory environment regionally and globally; provide assessments for the impact of new and changing regulations on the business unit.
• Communicate new regulations or changes to existing regulations throughout the organization through policies, procedures, and training.
• Represent the Regulatory function on project teams to ensure alignment of regulatory strategy and plans with team objectives.

• Key member of the Senior Leadership Team; communicate Quality Assurance and Compliance…