Role Overview for VP, Quality Assurance with a Pharmaceutical OEM – Kalamazoo, MI
JRG Partners is proud to represent a premier Pharmaceutical Original Equipment Manufacturer (OEM) in their search for a visionary and strategic Vice President of Quality Assurance. Based at their state-of-the-art facility in Kalamazoo, MI, this executive leadership role is critical to the continued success and growth of the organization.
The VP of Quality Assurance will serve as the ultimate authority on product quality, regulatory compliance, and the overall health of the Quality Management System (QMS). This individual will be responsible for crafting and executing a forward-thinking quality strategy that not only meets but exceeds global regulatory standards and client expectations.
As a key member of the executive leadership team, you will be instrumental in shaping a robust culture of quality that permeates every facet of the organization. You will provide strategic direction and operational oversight for all quality assurance and quality control functions, ensuring that all products manufactured on behalf of clients are safe, effective, and fully compliant with all applicable regulations.
Your leadership will directly impact the company’s reputation for excellence, its ability to secure and retain top-tier clients, and its long-term commercial success. This is a unique opportunity for a seasoned quality leader to make a significant impact within a dynamic, technology-driven pharmaceutical manufacturing environment, driving continuous improvement and setting new benchmarks for quality in the OEM space.
Key Responsibilities of VP, Quality Assurance with a Pharmaceutical OEM – Kalamazoo, MI
Strategic Leadership & Vision
- Develop, implement, and maintain a comprehensive, company-wide quality strategy that aligns with the organization’s strategic objectives and long-term growth plans.
- Serve as a key strategic partner to the CEO and executive team, providing expert counsel on all matters related to quality, compliance, and risk management.
- Champion a proactive, deeply embedded culture of quality excellence, accountability, and continuous improvement across all departments, from the shop floor to the C-suite.
- Establish and monitor key performance indicators (KPIs) and quality metrics to drive performance, report progress to the executive board, and identify areas for strategic enhancement.
- Oversee departmental budgeting, resource allocation, and long-range financial planning to ensure the Quality unit is equipped for success.
Regulatory Compliance & Inspection Management
- Ensure unwavering compliance with all relevant global regulatory requirements, including those from the FDA, EMA, Health Canada, and other international health authorities.
- Maintain expert-level knowledge of current and emerging regulations, including Current Good Manufacturing Practice (cGMP) regulations, ICH guidelines, and other industry standards.
- Act as the primary point of contact and lead host for all regulatory agency inspections (e.g., FDA PAI, general inspections) and major client audits, ensuring successful outcomes.
- Develop and execute robust strategies for inspection readiness, including mock audits, staff training, and facility preparation.
- Oversee the timely and effective response to any regulatory observations (e.g., FDA 483s, warning letters), ensuring comprehensive corrective actions are implemented and verified.
Quality Management System (QMS) Oversight
- Provide executive oversight for the entire Quality Management System, ensuring its effectiveness, efficiency, and compliance.
- Direct the management of all core QMS elements, including but not limited to: Deviation Management, CAPA (Corrective and Preventive Action), Change Control, and Out-of-Specification (OOS) investigations.
- Ensure the integrity and control of all GxP documentation, including Batch Records, SOPs, and validation protocols.
- Oversee the company-wide GxP training program, ensuring all employees are adequately trained for their roles and responsibilities.
- Drive the digital transformation of quality systems where appropriate, leveraging technology to improve efficiency, data integrity, and compliance.
Operational Quality & Product Lifecycle Management
- Lead the Quality Assurance and Quality Control departments to ensure timely and compliant review and disposition of raw materials, components, and finished products.
- Provide quality oversight for the entire product lifecycle, from technology transfer and process validation to commercial manufacturing and stability programs.
- Collaborate closely with Manufacturing, Engineering, and Supply Chain leaders to resolve complex quality issues, improve process capability, and reduce operational risk.
- Oversee the supplier quality management program, including the qualification, auditing, and ongoing monitoring of critical material suppliers and service providers.
- Direct the management of the annual product review (APR) process and the site’s stability testing program.
Team Leadership & Development
- Build, lead, and mentor a world-class team of quality professionals, fostering an environment of collaboration, innovation, and professional growth.
- Establish clear goals and objectives for the Quality organization, providing regular feedback, coaching, and performance management to direct reports and the broader team.
- Develop a succession plan for key roles within the Quality unit, identifying and cultivating high-potential talent.
- Promote a culture of empowerment and accountability, enabling the team to effectively manage their responsibilities and drive quality initiatives forward.
Requirements for the VP, Quality Assurance with a Pharmaceutical OEM – Kalamazoo, MI
Educational Background
- A minimum of a Bachelor of Science (B.S.) in a relevant scientific field such as Chemistry, Biology, Microbiology, Pharmacy, or a related Engineering discipline is required.
- An advanced degree (M.S., Ph.D., or Pharm.D.) is strongly preferred.
Professional Experience
- A minimum of 15 years of progressive, hands-on experience within the pharmaceutical or biotechnology industry in Quality Assurance and/or Quality Control roles.
- At least 7-10 years of experience in a senior leadership capacity (Director, Senior Director, or VP level) with a proven track record of managing large, multi-functional quality organizations.
- Direct experience within a contract manufacturing (CMO), contract development and manufacturing (CDMO), or OEM environment is highly desirable.
- Extensive experience successfully hosting inspections from major global regulatory bodies, particularly the FDA, is mandatory.
- Demonstrated experience in a sterile/aseptic manufacturing environment is a significant asset.
Skills and Competencies
- In-depth, expert knowledge of global cGMP regulations, ICH guidelines, and quality systems principles.
- Exceptional leadership and interpersonal skills, with the ability to influence and build consensus across all levels and functions of the organization.
- Strong strategic thinking and business acumen, with the ability to translate quality and compliance requirements into effective business strategies.
- Proven ability to lead and develop high-performing teams in a fast-paced, demanding environment.
- Excellent written and verbal communication skills, capable of presenting complex information clearly and concisely to executive leadership, regulatory agencies, and clients.
- Superior problem-solving, analytical, and risk-assessment skills.
- A continuous improvement mindset, with experience in methodologies such as Lean Manufacturing or Six Sigma being a plus.
Benefits & Perks Offered
Our client offers a highly competitive and comprehensive executive compensation and benefits package, designed to attract and retain top-tier talent. This includes:
- Highly Competitive Base Salary
- Substantial Annual Performance-Based Bonus
- Long-Term Incentive Program (e.g., Stock Options, Equity Grants)
- Comprehensive Health, Dental, and Vision Insurance Plans
- Generous 401(k) Retirement Plan with Company Match
- Significant Paid Time Off (PTO), including Vacation, Sick Days, and Paid Holidays
- Full Relocation Assistance Package for qualified candidates
- Life and Disability Insurance
- Professional Development and Continuing Education Support
- An opportunity to join a dynamic executive team and shape the future of a growing company
How to Apply
This is a retained search conducted exclusively by JRG Partners. If you are a transformative quality leader with the experience and passion to drive excellence in a pharmaceutical OEM setting, 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.
JRG Partners is a leader in executive recruitment for the life sciences industry. To learn more about our expertise and explore other opportunities, we invite you to visit our pharmaceutical and biotechnology executive search practice page. We look forward to connecting with you.
