VP, Quality Assurance & Regulatory Compliance

Job Description

TheVP, Quality Assurance & Regulatory Compliance is responsible for establishing strategies, planning and development of quality and regulatory compliance processes and procedures, insuring that EVERSANA is compliant to all applicable federal, state, and local regulations and standards, with a focus of Quality & Regulatory. Responsible for managing and directing the activities of the Quality & Regulatory Departments to ensure that the Company's processes and services comply and meet the regulatory requirements, with a focus on quality standards.

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by :

• Oversees Quality Assurance, setting quality goals and objectives consistent with established business unit and management goals, as well as FDA / DEA, State Boards Pharmacy, Accredited Bodies, GDP and ISO Quality Standards, as applicable.
• Promotes the development of a company-wide culture of quality awareness and understanding of the key elements related to quality system and regulatory compliance requirements.
• Serves as the Quality management representative for regulators, notified bodies and customer audits.
• Maintains knowledge of existing and emerging quality standards, regulations and guidance documents, as they pertain to Ripple products. Interprets changes to rules and standards and ensures that they are communicated through corporate policies as well as in Supplier Agreements.
• Supports and has ownership of audit processes for Supplier Qualification and Maintenance. Works cross functionally, in-house, and externally, to facilitate the Supplier Selection process.
• Has extensive experience in the selection and qualification of GxP suppliers and the transferring ot GxP responsibilities as well as preparing, reviewing, and approving the corresponding quality agreements.
• Works with SMEs in specific disciplines, both in-house as well as consultants, as needed to ensure expert technical review of controlled documents... Reviews and approves controlled documentation related to GxP activities outsourced to Qualified Suppliers, including deviations, OOS investigations, CAPAs, risk assessments, etc.
• Creates a quality documentation system by writing and updating quality assurance procedures.
• Supports Qualified Suppliers in the development of protocols for test method validations, design and process verifications and validations, biocompatibility, sterilization, shelf life, stability, and risk management to ensure compliance.
• Develops the Quality Assurance Unit by recruiting, selecting, orienting, and training QA staff.
• Ensures quality by planning, monitoring, and appraising job results.

• Responsible for driving implementation of and continued compliance with global regulatory requirements, interpreting and applying pertinent laws and regulations governing company services to meet business objectives.
• Leads development, implementation, and maintenance of regulatory processes at the business level.
• Supports the development of regulatory compliance strategies.
• Actively works with Business Unit Implementation Teams and / or commercial partners to ensure appropriate planning, tracking, and alignment of regulatory licensure submissions across all facilities.
• Serves as main Channel Management with Regulatory Authorities or, where appropriate, works in conjunction with regulatory consultants or clients to ensure compliance.
• Demonstrates sound understanding of related fields (e.g., controlled substance and cold chain products quality assurance) and ability to solve complex problems in collaboration with colleagues in other functions.
• Monitors the regulatory environment regionally / globally and provides assessments for the impact of new and changing regulations on the business unit’s areas of interest. Ensures new regulations or changes to existing regulations are communicated throughout the organization through policies, procedures, and training (where applicable).
• Represents the Regulatory function on project teams to ensure…