Vice President of Quality Assurance & Compliance – Medical Device

Retained Search

Our client is seeking an experienced and strategic leader to join their team as the Vice President of Quality Assurance & Compliance. In this critical role, you will be instrumental in ensuring the highest standards of quality and regulatory compliance across the organization. Reporting directly to the executive leadership team, you will lead the Quality and Regulatory Assurance and Compliance efforts, driving the implementation and adherence to the Quality Management System (QMS) and driving product quality performance to meet or exceed industry standards.

Responsibilities:

• Lead a team of the following disciplines: Product QA, Software QA, Quality Systems, and Post Market Surveillance.
• Responsible for maintaining compliance and the continuous improvement in the Quality & Regulatory Management System regarding ISO 9001, ISO 13485, ISO 14001, IEC 62304, EMS, CMDR SOR/98-282, MDD 93/42EEC and MDR 2017/745, and 21 CFR Part 820 and further regulatory requirements which apply to the product portfolio.
• Serve as the point of contact with the Notified Bodies.
• Serve as the primary contact for FDA, TÜV, regulatory, and third-party audits and inspections and/or preparation as necessary.
• Ensures that the cross-functional organization is aligned and prepared for audits and inspections.
• Defines Quality & Regulatory Management goals and ensures alignment with other relevant business goals.
• Analyzes and reviews quality management goals and breaks down corresponding goals for the relevant product quality targets.
• Drives the achievement of the agreed-upon targets to achieve business targets in both Quality and Process Performance.
• Refines and fosters a set of necessary quality statistics and methodologies. Responsible for CAPA, PQB, and QMS Boards.
• Serves as the Management Representative for ISO 9001, ISO 13485, FDA, ISO 14001 and as Person Responsible for Regulatory Compliance.
• Also responsible for providing periodic reporting on a local and global level.
• Provide leadership and guidance to and oversight of internal and external resources to ensure the company remains in compliance with applicable and phase-appropriate quality-related standards, regulations, and cGMP practices.
• Establish and maintain the quality & regulatory systems, including cGMP compliance, document control, training, CAPA, quality metrics, internal audits, management controls, software quality, and post-market surveillance.
• Serves as a member of the Management Team, provides information to management that could impact QA compliance, and promotes awareness of customer requirements and feedback to the management team.
• Manage Department budget and resources to address strategic needs within the Quality & Regulatory department, including hiring decisions, talent management, and mentoring development.
• Responsible for the implementation of an Integrated Management System.
• Ensure effective Quality System implementation within the CFTs and Product Steering Boards. Educates responsible organizations in all commercial and quality/process-relevant topics.
• Drives Software Quality Assurance (SWQA) and Compliance for new developments and legacy products. Promotes awareness of customer requirements, monitors quality performance, and communicates customer quality issues and resolution thereof.
• Assures product quality by involvement in the development process.

Requirements:

• Bachelor’s Degree in a scientific discipline, life sciences, biomedical or other engineering science – Master’s or a PhD (desired).
• Quality and Environmental (knowledge of current ISO 9001, ISO 13485, IEC 62304, ISO 14001).
• CMDR SOR/98-282, MDD 93/42/EEC and MDR 2017/745, 21 CFR Part 820, where applicable.
• A formal Six Sigma qualification is preferred.
• Minimum of 15 year’s experience in either a quality or regulatory role in the medical or safety device industry with at least 7 years in a management role.
• Ability to develop, implement, and manage an integrated QMS; to lead multi-level and multi-discipline work teams to develop, implement, and manage processes/business systems.
• Prefered experience in managing both quality and regulatory.
• Strong influencing skills at all levels to lead the decision-making process with executive management, peers, and subordinates.
• Sound people management and change management experience.
• Strong interpersonal and communication skills and the ability to persuade and influence others at all levels within the company.
• Capacity for analytical thought
• Proven track record in applicable disciplines of ISO 9001, ISO 13485, IEC 62304, US FDA and MDD compliant Quality Management and ISO 14001 Environmental Management systems and demonstrated success in developing a proactive organization in a compliant environment.

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