Role Overview for VP Laboratory Quality & Compliance – Indianapolis, IN
JRG Partners is proud to partner with a pioneering, high-growth clinical diagnostics organization in the search for a visionary Vice President of Laboratory Quality & Compliance. Based in the burgeoning life sciences hub of Indianapolis, IN, this executive leadership role is critical to the company’s mission of delivering accurate, reliable, and innovative diagnostic solutions that impact patient care globally. This is not merely an oversight position; it is a strategic role responsible for architecting, implementing, and leading a world-class quality culture across all laboratory operations.
The successful candidate will be a seasoned and dynamic leader with an unwavering commitment to excellence and an expert-level understanding of the complex regulatory landscape governing clinical laboratories. As the VP, you will serve as the ultimate authority on quality and compliance, providing strategic direction and hands-on leadership to ensure the laboratory not only meets but exceeds the most stringent industry standards. You will join a forward-thinking executive team and be empowered to build and mentor a high-performing quality organization, driving continuous improvement initiatives that enhance operational efficiency, ensure data integrity, and solidify the company’s reputation as a leader in the diagnostics field. This is a unique opportunity to make a significant impact on a rapidly scaling company at the forefront of medical innovation.
Key Responsibilities of VP Laboratory Quality & Compliance – Indianapolis, IN
The VP of Laboratory Quality & Compliance will have a broad and impactful scope of responsibilities, encompassing strategic leadership, tactical execution, and cross-functional collaboration. Your duties will include, but are not limited to:
Strategic Quality Leadership
Develop, champion, and execute a comprehensive, long-term vision and strategy for quality and compliance that aligns with the company’s overall business objectives. Serve as a key member of the executive leadership team, providing critical insights and guidance on all quality-related matters. Establish and manage the departmental budget, ensuring optimal allocation of resources to achieve quality goals.
Quality Management System (QMS) Oversight
Assume ultimate ownership of the Quality Management System. Direct the design, implementation, and continuous improvement of all QMS elements, including document control, change control, training programs, non-conformance and deviation management, and Corrective and Preventive Action (CAPA) systems. Ensure the QMS is robust, scalable, and fully compliant with all applicable regulations and standards.
Regulatory Compliance and Inspections
Serve as the primary point of contact and liaison with all regulatory and accrediting bodies, including the FDA, CLIA (CMS), CAP, New York State Department of Health (NYS DOH), and various international authorities. Proactively monitor the regulatory landscape for changes and ensure timely implementation of new requirements. You will be responsible for ensuring the laboratory maintains a constant state of inspection readiness and will lead the organization through all internal and external audits and regulatory inspections. This includes ensuring full adherence to federal and state regulations, including the FDA’s Good Laboratory Practice (GLP) regulations, CLIA, and CAP standards.
Audit Program Management
Design and oversee a comprehensive internal audit program to proactively identify areas of risk and opportunities for improvement. Manage all aspects of external audits, from preparation and hosting to formulating responses and tracking corrective actions to closure. Develop and maintain strong, collaborative relationships with auditors and inspectors.
Team Development and Mentorship
Recruit, lead, mentor, and develop a world-class team of quality assurance and compliance professionals. Foster a proactive, collaborative, and solution-oriented culture of quality that permeates every level of the organization. Set clear objectives, provide regular feedback, and create development pathways to ensure team growth and success.
Cross-Functional Collaboration and Influence
Partner closely with Laboratory Operations, Research & Development, IT, and Commercial teams to integrate quality principles into all aspects of the product and service lifecycle, from assay development and validation to routine testing and reporting. Provide expert quality and compliance guidance to support new product introductions and process changes.
Data Integrity and Performance Metrics
Establish and monitor Key Quality Indicators (KQIs) and other performance metrics to measure the effectiveness of the QMS. Champion data integrity initiatives across the laboratory. Prepare and present regular, comprehensive reports on quality system performance to the executive team and Board of Directors, highlighting trends, risks, and strategic initiatives.
Risk Management
Implement and maintain a proactive quality risk management program to identify, evaluate, and mitigate potential risks to product quality, patient safety, and regulatory compliance.
Requirements for the VP Laboratory Quality & Compliance – Indianapolis, IN
We are seeking an exceptional leader with a proven track record of success in building and leading quality functions within complex laboratory environments. The ideal candidate will possess the following qualifications:
Required Qualifications:
Education
An advanced degree (M.S. or Ph.D.) in a relevant scientific discipline such as Molecular Biology, Chemistry, Biochemistry, or a related Life Sciences field is required.
Experience
A minimum of 15 years of progressive experience in Quality Assurance and/or Regulatory Affairs within a CLIA/CAP-certified clinical laboratory, in-vitro diagnostics (IVD), medical device, or pharmaceutical environment. A minimum of 7-10 years of experience in a senior leadership capacity (Director level or above) with demonstrated experience managing and developing teams.
Regulatory Expertise
Expert-level, in-depth knowledge and practical application of regulations and standards governing clinical laboratories, including CLIA ’88, CAP, ISO 15189/17025, NYS DOH, and FDA regulations (e.g., 21 CFR Part 820, QSR).
Proven Leadership
Demonstrated success in leading a company through successful regulatory inspections by multiple agencies (e.g., FDA, CAP, NYS DOH). Proven ability to build, scale, and lead a high-performing quality organization.
QMS Mastery
Extensive, hands-on experience in developing, implementing, and managing all aspects of an electronic Quality Management System (eQMS).
Strategic Acumen
Must be a strategic thinker with the ability to translate high-level goals into actionable plans. Possesses exceptional analytical, problem-solving, and decision-making skills.
Communication Skills
Superior written and verbal communication skills, with the ability to effectively communicate complex regulatory and quality concepts to a wide range of audiences, from lab technicians to the Board of Directors.
Preferred Qualifications:
- Professional certifications such as ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or Regulatory Affairs Certification (RAC).
- Experience with advanced laboratory technologies, such as Next-Generation Sequencing (NGS), molecular diagnostics, or mass spectrometry.
- Formal training and certification in continuous improvement methodologies like Lean or Six Sigma (Green or Black Belt).
- Experience with international laboratory regulations and submissions.
- Experience in a fast-paced, high-growth startup or scale-up environment.
Benefits & Perks Offered
Our client offers a highly competitive executive compensation and benefits package designed to attract and retain top-tier talent, including:
- Competitive base salary and an aggressive annual executive bonus program.
- Meaningful equity participation through stock options or RSUs.
- Comprehensive health, dental, and vision insurance plans for you and your dependents.
- A robust 401(k) retirement plan with a generous company match.
- Substantial Paid Time Off (PTO) policy, including vacation, sick leave, and paid company holidays.
- A comprehensive relocation package to assist with your move to the Indianapolis area.
- A generous professional development allowance to support attendance at conferences, workshops, and continuing education.
- A dynamic, collaborative, and mission-driven work environment where your contributions are valued and have a direct impact on patient outcomes.
How to Apply
JRG Partners has been exclusively retained for this critical search. If you are a transformative quality leader ready to take on a new challenge and make a lasting impact in the diagnostics industry, we encourage you to apply.
To express your interest in this executive opportunity or to learn more, please connect with our dedicated recruitment team. For more information or to apply for this executive opportunity, please visit our Molecular Technologist Recruiters practice area to submit your resume and cover letter. All inquiries and applications will be handled with the strictest confidence.
