Director, Quality Assurance Combination Products

Position Summary:

The Director, Quality Assurance Combination Products will report to the Vice President of Quality Assurance and oversee the quality oversight of design controls and risk management of the combination product projects from inception through commercialization. The ideal candidate will have a strong background in drug delivery systems, medical devices, and combination product regulations involving biologics. Exceptional organizational, clear communication, strong interpersonal skills, and strategic agility are essential for effectively conveying quality requirements to stakeholders across various functions and external partners. This role will involve collaboration with cross-functional teams and external partners to ensure that combination products meet regulatory standards and are safe and effective for patient use.

Responsibilities:

• Oversee the quality and compliance of combination products, ensuring they meet regulatory standards and company objectives.
• Develop and implement quality strategies and processes for combination products, in alignment with company goals and regulatory requirements.
• Act as the QA contact for all quality-related inquiries and issues concerning device and combination products.
• Collaborate with cross-functional teams, including product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs, to ensure quality and compliance throughout the combination product lifecycle.
• Help define and implement quality standards, specifications, methods, systems, and metrics for clinical and commercial quality operations.
• Stay up-to-date with changes in medical device and combination product regulations and industry best practices.
• Participate in the development, review, and approval of product documentation, including design control, risk management, and validation.
• Identify gaps and improvement opportunities within the Design History File and Risk Management and track to closure.
• Collaborate with external partners and suppliers to ensure quality and compliance with company standards. Perform quality assurance oversight for validation studies conducted by external partners.
• Communicate effectively with senior management to provide updates on the status of quality and compliance for medical device/combination product.
• Participate in preparation for and execution of regulatory audits. Ensure audit observations related to the functional area are addressed appropriately and completed on schedule.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Availability for 5-15% travel, both domestically and internationally.