Senior Director, Quality Assurance & Regulatory Compliance

Senior Director, Quality Assurance & Regulatory Compliance – Memphis, Tennessee, United States Job Description

The Senior Director, 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. The role manages and directs the activities of the Quality & Regulatory Departments to meet regulatory requirements and quality standards.

• 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 the development of a company‑wide culture of quality awareness and understanding of key elements of 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, communicate changes through corporate policies and Supplier Agreements.
• Support and own audit processes for Supplier Qualification and Maintenance, facilitating the Supplier Selection process.
• Consult on the selection and qualification of GxP suppliers, transfer of GxP responsibilities, and prepare, review, and approve corresponding quality agreements.
• Work with SMEs and consultants to ensure expert technical review of controlled documents, 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, process verifications and validations, biocompatibility, sterilization, shelf life, stability, and risk management.
• Develop the Quality Assurance Unit by recruiting, selecting, orienting, and training QA staff.
• Ensure quality by planning, monitoring, and appraising job results.

• Drive implementation and continued compliance with global regulatory requirements, interpreting applicable laws and regulations.
• 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 commercial partners to plan, track, and align regulatory licensure submissions across all facilities.
• Serve as main channel manager with regulatory authorities or work with consultants to ensure compliance.
• Understand related fields (e.g., controlled substances and cold chain products) and solve complex problems in collaboration with other functions.
• Monitor the regulatory environment regionally and globally, assess impacts of new and changing regulations, and communicate changes through policies, procedures, and training.
• Represent the Regulatory function on project teams to align regulatory strategy with project objectives.

• Key member of the Senior Leadership Team, communicating important QA & Regulatory information to management and other departments.
• Establish Quality and Regulatory Compliance strategies and plans aligned with Business Unit objectives.
• Interview, select, supervise, and evaluate department staff; ensure company policies and procedures are followed.
• Determine job objectives, work methods, and performance standards; review performance and administer personnel actions.
• Promote a culture of quality awareness and understanding of key elements of the quality system and regulatory compliance.
• Oversee regulated activities to meet federal, state, and local regulations.
• Enhance key elements of the quality system through continuous improvement of the QMS and documentation.
• Drive regulatory strategy and collaborate with consultants; lead regulatory inspections and respond to regulatory letters and observations.
• Ensure all channel‑managed contracted services comply with applicable regulations to avoid service…