Director, Quality Assurance, Combination Products

• →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 as appropriate quality standards/specification, 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. Ensures audit observations related to 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.

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred.
• 10+ years of experience in quality oversight of drug product device development, with a proven track record of successful product launches.
• Experience in quality oversight of design controls and combination products is required.
• In-depth knowledge of global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971 and EU MDR.
• Familiar with combination product lifecycle management from initial design phase to commercialization.
• Experience with quality oversight of biological drug products and working CMOs in a plus.
• Excellent communication and interpersonal skills in working across the organization and external partners.
• Ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
• Ability to operate in alignment with Vera’s Core Values.

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