BS in life sciences, engineering, pharmacy, or related field; advanced degree preferred
15+ years of progressive Quality experience in regulated life sciences
7+ years leading senior quality teams
Experience in Biologics preferred; familiarity with Cell/Gene Therapy and Med Devices is a plus
Expert knowledge of FDA regulations and quality standards, including 21 CFR and ISO 13485
Proven experience with BLA submissions and post-approval compliance
Track record of transforming quality departments and engaging with C-level executives
Responsibilities
Partner with cross-functional leaders to integrate quality into key business decisions
Lead risk-based oversight for critical suppliers and service providers
Build and retain a high-performing Quality organization with clear accountabilities
Manage the quality function's budget, resource planning, and executive reporting
Continuously improve an integrated, risk-based Quality Management System
Ensure disciplined execution across various quality processes and controls
Serve as the senior Quality representative with regulatory authorities and business partners
Lead inspection readiness and agency interactions
Provide quality leadership throughout product development and commercialization
Shape quality strategy to align with company mission and growth priorities
Benefits
Direct hire opportunity
Onsite work model
Open to relocation
Opportunity to shape quality strategy and impact company growth
Engagement with regulatory authorities and industry leaders
Full Job Description
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
