Role Overview for Chief Quality Officer – Philadelphia, PA
JRG Partners is proud to partner with a pioneering, growth-oriented medical device company in their search for a visionary Chief Quality Officer (CQO). Based in the vibrant life sciences hub of Philadelphia, PA, this executive leadership role is a career-defining opportunity to shape the future of quality and regulatory excellence within a dynamic and innovative organization. The CQO will serve as the ultimate authority and strategic leader for all aspects of the global Quality Management System (QMS) and regulatory compliance.
This is not merely an oversight role; it is a transformative position responsible for embedding a world-class culture of quality that permeates every facet of the organization, from initial concept to post-market surveillance. The ideal candidate will be a strategic thinker with a hands-on approach, capable of navigating the complex global regulatory landscape while inspiring a large, multi-disciplinary team towards a unified vision of unparalleled product safety, efficacy, and compliance.
You will be a key member of the executive team, reporting directly to the CEO, and your contributions will directly impact patient outcomes and the company’s long-term success and market leadership. This role demands a leader who can balance rigorous adherence to standards with the agility required to support rapid innovation in the fast-paced medical device sector.
As the Chief Quality Officer, you will be the conscience of the company, ensuring that every product released meets the highest standards of safety and quality. Your leadership will be critical in maintaining the company’s reputation and trust with patients, healthcare providers, and regulatory bodies worldwide. You will architect and implement a forward-thinking quality strategy that not only ensures compliance with current regulations but also anticipates future trends and challenges. This involves championing continuous improvement initiatives, leveraging data analytics to drive quality decisions, and fostering a proactive, rather than reactive, approach to quality management.
You will be the principal advocate for quality at the executive table, ensuring that it is a key consideration in all strategic business decisions, including new product development, market expansion, and mergers and acquisitions. Your ability to build strong, collaborative relationships with cross-functional leaders in R&D, Operations, and Commercial will be paramount to your success in this pivotal role.
Key Responsibilities of Chief Quality Officer – Philadelphia, PA
The Chief Quality Officer will have a broad and impactful scope of responsibilities, encompassing strategic direction, operational execution, and team leadership. Success in this role requires a blend of deep technical expertise, exceptional leadership skills, and strong business acumen. Key responsibilities include:
Strategic Quality and Regulatory Leadership
Develop, articulate, and execute a comprehensive global quality and regulatory affairs strategy that aligns with the company’s overall business objectives. Establish long-range goals, policies, and procedures to ensure robust and sustainable compliance across all global operations.
QMS Development and Oversight
Assume ultimate ownership of the corporate Quality Management System (QMS). Ensure the QMS is effective, efficient, and fully compliant with all applicable standards, including ISO 13485, MDSAP, EU MDR/IVDR, and FDA regulations. Drive continuous improvement of all QMS subsystems, including document control, training, internal audits, and management review.
Global Regulatory Compliance
Serve as the primary point of contact and lead strategist for all interactions with global regulatory agencies, including the FDA, Notified Bodies, and other international health authorities. Oversee the preparation, submission, and maintenance of all regulatory filings, such as 510(k)s, PMAs, and Technical Files. Expertly manage all regulatory inspections and audits, ensuring successful outcomes.
Product Lifecycle Quality Assurance
Integrate quality principles and practices throughout the entire product lifecycle. Provide quality and regulatory leadership for new product development, ensuring compliance with design controls, risk management, and validation requirements. Oversee quality for manufacturing, supply chain, and post-market activities, including complaint handling and vigilance reporting.
Risk Management Leadership
Champion a robust, proactive risk management program in accordance with ISO 14971. Ensure that risk is managed effectively from product concept through obsolescence, and that risk management principles are integrated into all key QMS processes and business decisions.
Corrective and Preventive Action (CAPA) Program
Oversee the global CAPA system to ensure that systemic issues are identified, investigated, and resolved in a timely and effective manner. Promote a culture of transparency and root cause analysis to prevent recurrence and drive systemic improvements.
Executive Team Collaboration
Serve as a vital member of the executive leadership team, providing critical insights and guidance on quality and regulatory matters. Collaborate effectively with R&D, Operations, Clinical, and Commercial leaders to achieve business goals while maintaining the highest standards of compliance.
Team Development and Mentorship
Lead, mentor, and develop a high-performing, global Quality and Regulatory organization. Foster a culture of excellence, accountability, and continuous learning. Attract and retain top talent to build organizational capability for the future.
Supplier Quality Management
Establish and maintain a robust supplier quality program, including supplier qualification, auditing, and performance monitoring, to ensure the integrity and quality of the entire supply chain.
Requirements for the Chief Quality Officer – Philadelphia, PA
This executive position requires a seasoned leader with a proven track record of success in the medical device industry. The successful candidate will possess a unique combination of technical expertise, strategic vision, and inspirational leadership qualities. Specific qualifications include:
Educational Background
A minimum of a Bachelor of Science (B.S.) degree in Engineering, Life Sciences, or a related technical field is required. An advanced degree (M.S., M.B.A., or Ph.D.) is strongly preferred.
Executive Experience
A minimum of 15 years of progressive experience in quality assurance and regulatory affairs within the medical device industry. At least 7 years of this experience must be in a senior leadership capacity (e.g., Vice President, Senior Director) with responsibility for managing large, global teams and setting strategic direction.
Regulatory Expertise
Demonstrated mastery of global medical device regulations. This includes in-depth, practical knowledge of FDA’s Quality System Regulation (QSR) (21 CFR Part 820), ISO 13485, the Medical Device Single Audit Program (MDSAP), the European Medical Device Regulation (EU MDR), and other key international standards. Experience with both Class II and Class III devices is essential.
Leadership and Communication
Proven ability to lead and inspire a global organization. Exceptional communication, presentation, and interpersonal skills, with the ability to effectively influence and negotiate with internal and external stakeholders, including executive leadership and regulatory authorities.
Strategic and Analytical Skills
Strong strategic thinking capabilities with the ability to translate business goals into actionable quality and regulatory strategies. Data-driven mindset with strong analytical and problem-solving skills.
Proven Track Record
A history of successfully leading companies through FDA inspections, Notified Body audits, and other regulatory assessments. Experience in remediation activities, M&A due diligence, and integration is highly desirable.
Certifications
Professional certifications such as ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or RAPS RAC (Regulatory Affairs Certification) are highly valued.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent. They offer a highly competitive and comprehensive compensation and benefits package designed to reward your contributions and support your well-being. This includes:
Executive Compensation
A highly competitive base salary complemented by a significant annual performance-based bonus and a substantial long-term equity incentive package.
Comprehensive Health and Wellness
Premier medical, dental, and vision insurance plans for you and your eligible dependents. Includes access to wellness programs, mental health resources, and an employee assistance program.
Retirement Savings
A generous 401(k) retirement plan with a significant company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick days, and company holidays, to support a healthy work-life integration.
Relocation Support
A comprehensive relocation package is available for the successful candidate and their family to assist with the move to the greater Philadelphia area.
Professional Development
A strong commitment to your professional growth with support for continuing education, executive coaching, and participation in industry conferences and events.
Impactful Work
The opportunity to join a mission-driven company where your work directly contributes to improving and saving lives.
How to Apply
This is an exclusive search being conducted by JRG Partners. If you are a transformative quality leader with the experience and passion to drive excellence in a cutting-edge medical device company, we encourage you to apply. To be considered for this confidential opportunity, please submit your resume and a cover letter outlining your qualifications and interest in the role.
JRG Partners specializes in connecting elite talent with leading companies in the life sciences sector. To learn more about our expertise and explore other opportunities, we invite you to visit the JRG Partners’ Medical Device recruitment practice page. All inquiries and applications will be handled with the utmost discretion and confidentiality. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
