SVP Quality Systems

Job Title: SVP Quality Systems Location: Canton, Massachusetts Type: Direct Hire Work Model: Onsite Salary: $350-$400k + 30% managerial bonus Open to relocation

Responsibilities

• Partner with Operations, Manufacturing, Research & Development, Regulatory Affairs, Clinical, Medical Affairs, Supply Chain, Commercial, and other leaders to integrate quality into portfolio, capacity, supply, partnership, and operating decisions
• Lead risk-based qualification and performance oversight for critical suppliers, contract laboratories, contract manufacturers, tissue recovery and processing partners, distributors, and other service providers
• Build, develop, and retain a high-performing Quality organization with clear accountabilities, strong succession plans, and capabilities that scale with the business
• Lead the function’s budget, resource plan, performance objectives, and executive-level reporting on quality strategy, risk, inspection readiness, and remediation
• Own and continuously improve an integrated, risk-based QMS for company product and regulatory landscape
• Ensure disciplined execution across document control, training, deviations and nonconformances, investigations, CAPA, change control, validation, audits, supplier qualification, risk management, management review, data integrity, complaints, and recalls.
• Serve as the senior Quality representative with the FDA and other regulatory authorities, notified bodies, tissue-bank regulators and accreditors, customers, and business partners
• Lead inspection readiness, agency interactions, formal responses, commitments, and sustainable remediation
• Provide quality leadership from development through commercialization and lifecycle management, including design controls, technology transfer, validation, release, stability, post-market surveillance, complaints, field actions, and product changes
• Set and execute a clear, enterprise-wide quality vision aligned with company mission, growth priorities, product portfolio, development pipeline, and commitments to patients and healthcare providers
• Will shape quality strategy, strengthen our company-wide Quality Management System, and ensure that quality and compliance enable reliable supply, innovation, and sustainable growth

Requirements

• Education: BS degree in life sciences, engineering, pharmacy, or a related discipline; an advanced scientific, technical, or business degree is preferred
• Experience: Minimum of 15+ yrs. of progressive Quality exp. in regulated life sciences, including substantial leadership responsibility in commercial manufacturing
• Minimum of 7+ yrs. leading senior quality teams
• Exp. from the Biologics industry is preferred. Followed by Cell/Gene Therapy, human tissue products, combination products, or Med Device.
• Exp. from a mixture of small/startup to large size companies is a plus
• “MUST HAVES”: Expert exp./knowledge of working with the FDA and applicable FDA requirements and quality standards, including 21 CFR Parts 210, 211, 600, 820/QMSR, and 1271, as relevant; ISO 13485; and recognized tissue-banking standards
• BLA experience
• Proven exp. and accomplishments in engaging with FDA CBER for BLA submissions and post-approval Biologics compliance
• Exp. bringing a product to market (start to finish)
• Exp. “rebuilding”/transforming an entire quality dept. (knowing what needs to be done for a BLA vs. what could be done long term)
• Proven track record of developing relationships with other departments within a company to get the job done
• Exp. managing high level team members (i.e. Sr. Directors, Directors etc.)
• Proven track record of speaking with C Level executives and presenting in front of them and the Board of Directors
• Proven exp. overseeing an entire Quality Systems department
• Location: Westwood, MA area
• Start Date: ASAP!

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #LI- Ref: #558-Scientific