Senior Director/Head of Quality Assurance

Job Description

Senior Director/Head of Quality Assurance is responsible for the strategic development and operational management of Reviva’s quality assurance program and is accountable for the execution and administration of the GXP Quality Systems to support Good Manufacturing Processes (GMP), Good Laboratory Practices (GLP), Good Clinical Processes (GCP), and Pharmacovigilance (PV) Quality compliance in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. The scope of this leadership role includes ensuring GMP, GLP, GCP, and PV compliance and quality systems at Reviva and its vendors. This position requires expertise in current GMP, Good Clinical Practices GCP, PV Quality and GLP and relevant regulations. This role is accountable for ensuring that sites and vendors are compliant with global regulations, prepared for potential Sponsor Audits and Regulatory Inspections and that the appropriate processes, systems, and activities are in place and performed to protect patient safety, product quality, and data integrity. The Head of Quality Assurance will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters.

Essential Duties and Responsibilities:

• Lead the Quality Assurance department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training) as Reviva programs transition from early phase through clinical & commercial development/manufacturing to release readiness
• Lead the development, implementation, and management of GXP quality and compliance systems and policies, including the development of QA and QC processes and procedures
• Assess current, and where needed, develop corporate and/or other organizational polices related to GXP compliance and oversee their implementation, including quality standards and SOPs
• Implement governance plan to ensure good communication and decision making at the appropriate levels for quality related topics
• Ensure company is regulatory inspection ready at all times
• Oversee the planning and conduct internal and external audits to ensure compliance with GCP regulatory requirements for clinical trials, GLP regulatory requirements for IND/NDA enabling non-clinical studies, and GMP regulatory requirements for investigational and commercial drug manufacturing, and ensure corrective actions are implemented to resolve audit findings
• Manage, as the primary point of contact, internal and regulatory agency inspections
• Develop proactive approaches and provide strategic direction to implement quality standards and procedures for GXP regulatory compliance to meet company needs
• Led by functional representatives, ensure development, implementation, and maintenance of Quality Systems and SOPs related to GMP/GCP/PV activities.
• Lead Quality investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with deviations and investigations.
• Ensure Technical Operations and GCP/GLP/PV vendor activities are compliant with cGMP, FDA, ICH, EMA regulations and guidelines and industry standards.
• Stay abreast of industry developments – forthcoming regulations, guidance, best practices, etc., training, and mentoring staff on global GMP/GLP/GCP/PV regulations and guidance.
• Identify quality improvement needs and opportunities and assure that appropriate personnel address the issues. Assure corrective actions are implemented
• Advise Company's Executive Team on the implications and risks related to key Quality issues and important strategic decisions; keeping all posted, on a timely basis

Job Requirements

• Advanced degree, ideally in chemistry, biochemistry, microbiology or life sciences, related field with at least 15 years of experience in positions of substantial management responsibility within Quality Assurance
• Strong working knowledge of global GxP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct.
• Strong working knowledge of Quality Management Systems (QMS)
• Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
• Proven track record in establishing a quality organization and managing GMP/GCP Quality staff.
• Demonstrated success leading and motivating cross-functional teams and managing direct reports.
• Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical and operations staff
• Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections
• Experience with documentation systems, document review and auditing responsibilities
• Ability to effectively present information to top management, and/or boards of directors
• Demonstrated ability in setting successful quality strategies and building and leading the function
• Knowledge of relevant regulations, including FDA, EMEA, ICH.
• Ability to think strategically and translate into action
• Available to travel if/when needed.