About the Job

The VP, Regulatory Affairs and Quality Assurance will be a key strategic member of the senior leadership team, responsible for overall management of Regulatory and Quality activities in support of Foundation Medicine’s growth objectives. In addition to their externally-facing activities, they will play an important role collaborating cross-functionally with Global Laboratory Operations, Product Development, Marketing, Manufacturing, Legal and certain strategic outside partners.  The head of RA/QA will be a key leader in enhancing and developing the organizations RA/QA capabilities and qualifications to enable strategic initiatives. 

Key Responsibilities

• Development, implementation, maintenance and overall success of the company’s regulatory affairs and quality assurance strategy & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing supplier relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality. 
• Building and managing relationships with FDA and global regulatory agencies and standards groups. 
• Defining and implementing regulatory strategies and submissions in support of new and existing products as relevant. 
• Developing and maintaining current regulatory knowledge and staying abreast of regulatory procedures and changes, interpreting regulations, providing regulatory insight, advice and support to other functions. 
• Leads internal and external quality audits and preparation of audit reports, corrective action plans and follow up updates. 
• Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective. 
• Oversee global regulatory strategy and submissions in compliance with all applicable global regulatory requirements and in alignment with corporate goals. 
• Serve as the company representative for the FDA and other relevant external stakeholders, including Twist Biopharmaceutical partnerships. 
• Ensure supplier quality objectives are met.
• Provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the product pipelines. 
• Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of Quality. 
• Implement, monitor, and promote best practices of Quality Management Systems to ensure compliance with relevant FDA, EU, and global regulations/directives/requirements.
• Identify, resolve, or escalate any and all product, process or customer Quality-related issues that pose risk with respect to the patient, customers or compliance. 
• Develop and manage department and study-specific budgets. 
• Will be part of a Global Leadership Team and will need to collaborate effectively on broader initiatives. 

Qualifications:

Basic Qualifications:

• Bachelor’s degree in relevant area of engineering or scientific discipline. Advanced degree (MS or PhD) is strongly preferred. 
• Demonstrated and proven experience within their area of work and 15+ years of equivalent combined regulatory and quality professional experience. 
• 10+ years of leadership experience of cross functional teams. 

Preferred Qualifications:

• Advanced Degree in Law, Health Policy, Regulatory Affairs or Science 
• Experience with in vitro diagnostics, laboratory-developed tests, diagnostics medical device products, and/or therapeutics development including hands-on experience in developing and implementing policies and procedures for Regulatory Affairs and Quality 
• The VP RA/QA will be analytical, results and process oriented by nature, detail driven, possesses strong interpersonal skills, and have a desire and passion for quality and regulatory compliance. 
• Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities with direct experience handling submissions [e.g., PMA, 510(k), CE Marking]. 
• Direct experience with FDA Quality System Regulations and ISO 13485 regulatory requirements and implementation. 
• 5+ years’ experience in Regulatory and Quality strategy development 
• 5+ years’ experience in companion diagnostic work 
• Extensive experience in preparing and leading engagements directly with regulatory agencies. Ability to coach others to do the same. 
• A commercial focus in the application of regulatory requirements. 
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving. 
• Strong conceptual, analytical, and problem-solving abilities. 
• Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines. 
• Understanding of HIPPA and importance of patient data privacy 
• Ability to travel based on business needs, typically 10-20%, but flexing higher when needed. 
• Commitment to reflect FMI’s values: passion, patients, innovation, and collaboration. 

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