Role Overview for VP, Global Quality with a Pharmaceutical OEM – Kalamazoo, MI
JRG Partners is proud to partner with a world-class pharmaceutical Original Equipment Manufacturer (OEM) at the forefront of medical innovation. Our client is a global leader dedicated to developing and manufacturing life-saving therapies that impact patients worldwide. We are conducting an executive search for a transformative leader to join their senior leadership team as the Vice President of Global Quality, based at their key manufacturing and development campus in Kalamazoo, Michigan.
This is a career-defining opportunity to shape the quality culture, strategy, and execution for a dynamic and growing organization. The VP of Global Quality will serve as the ultimate authority on all quality and compliance matters across the company’s global footprint. This executive will be responsible for the strategic direction and operational leadership of the entire Quality organization, ensuring that all products are manufactured, tested, and released in compliance with global regulatory standards and internal quality requirements.
The ideal candidate is a strategic visionary with an unimpeachable record of integrity, a deep and practical understanding of the global pharmaceutical regulatory landscape, and a proven history of building and leading high-performance, multi-site quality organizations. You will be a key member of the executive team, providing critical quality and compliance insights to inform business strategy and drive a proactive, sustainable culture of excellence. This role requires a leader who can operate at a high strategic level while also maintaining a strong connection to operational realities, fostering an environment where quality is a shared responsibility and a competitive advantage.
Key Responsibilities of VP, Global Quality with a Pharmaceutical OEM – Kalamazoo, MI
The Vice President of Global Quality will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Quality Leadership
Develop, articulate, and execute a global quality vision and multi-year strategy that aligns with the company’s overall business objectives. Establish and monitor key quality performance indicators (KPIs) and metrics, reporting progress and strategic recommendations to the CEO and Board of Directors. Champion a culture of continuous improvement and quality-by-design principles throughout the organization.
Global Quality Management System (QMS) Oversight
Provide executive oversight for the architecture, implementation, and continuous enhancement of the global QMS. Ensure the QMS is robust, scalable, and compliant across all sites, covering all GxP areas including document control, change control, deviation management, CAPA, training, and data integrity.
Regulatory Compliance and Inspection Management
Serve as the primary point of contact and company representative for all regulatory agencies (e.g., FDA, EMA, PMDA). Ensure the organization is in a constant state of inspection readiness. Lead the successful management of all regulatory inspections and audits, and oversee the development of comprehensive, timely responses to any observations. Maintain expert-level knowledge of evolving global regulations and Current Good Manufacturing Practices (cGMP).
Operational Quality Excellence
Partner closely with Manufacturing, Supply Chain, R&D, and Commercial leaders to integrate quality principles into all aspects of the product lifecycle. Provide quality oversight for all manufacturing operations, including batch record review, product disposition, and release processes. Oversee the management of the product complaint system, ensuring timely investigation and resolution.
Team Leadership and Talent Development
Lead, mentor, and develop a world-class global quality organization. Attract, retain, and develop top talent, building a strong leadership pipeline within the Quality function. Foster a collaborative, engaging, and inclusive team environment. Manage the global quality budget, resource allocation, and long-range organizational planning.
Supplier and External Partner Quality
Establish and direct the supplier quality management program, ensuring all raw material suppliers, service providers, and contract partners meet stringent quality standards. Oversee the negotiation and maintenance of Quality Agreements with Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), and other critical partners.
Quality Risk Management (QRM)
Champion the integration of QRM principles across the organization in alignment with ICH Q9. Oversee the implementation of risk assessment tools and methodologies to proactively identify and mitigate quality and compliance risks in processes, systems, and products.
Requirements for the VP, Global Quality with a Pharmaceutical OEM – Kalamazoo, MI
We are seeking a distinguished leader with a deep passion for quality and patient safety. The successful candidate will possess the following qualifications:
Educational Background
An advanced degree (M.S., Ph.D., or Pharm.D.) in a relevant scientific or engineering discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) is strongly preferred. A Bachelor’s degree in a scientific field is required.
Professional Experience
A minimum of 15-20 years of progressive experience within the pharmaceutical, biotechnology, or life sciences industry, with at least 10 years in a senior quality leadership role (Director, Senior Director, VP) with multi-site and global responsibilities.
Technical Expertise
Demonstrated expert knowledge of global GxP regulations, including FDA (21 CFR Parts 210, 211, 820), EMA (Eudralex), ICH guidelines (Q7, Q8, Q9, Q10), and other international standards. Extensive experience hosting successful regulatory inspections is mandatory. Experience with a variety of product types, such as sterile injectables, biologics, and/or small molecules, is highly desirable.
Leadership Competencies
Proven ability to lead and inspire a large, geographically dispersed team. Exceptional strategic thinking, problem-solving, and decision-making skills. Must possess executive presence and the ability to effectively communicate and influence at all levels of the organization, from the manufacturing floor to the boardroom.
Business Acumen
Strong financial acumen with experience managing significant departmental budgets. A demonstrated ability to operate as a true business partner, balancing compliance requirements with business objectives and operational realities.
Personal Attributes
Unquestionable ethics and integrity. A proactive, hands-on leadership style. High emotional intelligence and strong interpersonal skills. A resilient and adaptable mindset, capable of thriving in a fast-paced, high-stakes environment.
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:
Competitive Compensation
A highly attractive base salary, annual performance-based bonus, and a significant long-term incentive package (e.g., stock options, restricted stock units).
Comprehensive Health & Wellness
A full suite of benefits including premium medical, dental, and vision insurance for you and your eligible dependents.
Retirement Savings
A robust 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and paid company holidays.
Relocation Assistance
A comprehensive relocation package is available for the successful candidate and their family to move to the beautiful Kalamazoo, Michigan area.
Professional Growth
A strong commitment to professional development, including support for attending industry conferences and executive leadership training.
How to Apply
JRG Partners is the exclusive executive search firm retained for this critical leadership position. If you are a visionary quality leader ready to make a significant impact on global health, we encourage you to apply.
To be considered for this confidential opportunity, please submit your resume and a cover letter detailing your qualifications. All inquiries and applications will be handled with the utmost discretion. For more information about our expertise in this sector, please visit our Pharmaceutical & Biotechnology Recruiting practice area.
Our client is an Equal Opportunity Employer and celebrates diversity and inclusion in the workplace. We are committed to creating a community where all employees can thrive.
