Role Overview for VP Sterile Operations with a Contract Injectables Manufacturer– Raleigh, NC
JRG Partners is proud to represent a premier, rapidly expanding contract injectables manufacturer in their exclusive search for a transformative Vice President of Sterile Operations. Located in the heart of the vibrant Research Triangle Park (RTP) in Raleigh, North Carolina, our client is a leader in providing critical sterile manufacturing services to pharmaceutical and biotechnology companies worldwide. This is a pivotal executive leadership position for a strategic and operationally-driven individual poised to make a significant impact on the company’s trajectory and, ultimately, on patient lives.
As the Vice President of Sterile Operations, you will be the strategic architect and hands-on leader for the entire sterile manufacturing value stream. You will hold ultimate accountability for the safety, quality, compliance, and performance of all aseptic production activities. This role requires a visionary leader who can not only manage complex day-to-day operations but also drive a culture of continuous improvement, innovation, and unwavering regulatory adherence. You will be responsible for scaling operations to meet increasing client demand, integrating new technologies, and developing a world-class team. This is a unique opportunity to join a dynamic executive team and steer the operational core of a company at the forefront of injectable drug manufacturing.
Key Responsibilities of VP Sterile Operations with a Contract Injectables Manufacturer– Raleigh, NC
The VP of Sterile Operations will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Leadership and Operational Vision
Develop and execute a multi-year strategic plan for sterile operations that aligns with the company’s overall growth objectives. Establish and meticulously track key performance indicators (KPIs) across safety, quality, delivery, and cost to drive performance and report progress to the executive leadership team.
Aseptic Manufacturing Oversight
Provide comprehensive leadership and direction for all sterile production departments, including formulation, component preparation, aseptic filling, lyophilization, and inspection. Ensure production schedules are met on time and within budget while maintaining the highest standards of quality and compliance.
Regulatory Compliance and Inspection Readiness
Act as the primary operational leader during regulatory inspections by agencies such as the FDA, EMA, and others. Guarantee that all facilities, equipment, processes, and documentation (e.g., batch records, SOPs) are maintained in a constant state of inspection readiness and adhere to current Good Manufacturing Practices (cGMP).
Operational Excellence and Continuous Improvement
Champion and instill a robust culture of operational excellence and continuous improvement throughout the organization. Utilize methodologies such as Lean Manufacturing, Six Sigma, and Right-First-Time (RFT) principles to enhance efficiency, reduce waste, minimize deviations, and optimize production workflows.
Team Leadership, Mentorship, and Development
Lead, mentor, and develop a high-performing operations organization. This includes attracting and retaining top-tier talent, setting clear performance expectations, and fostering a collaborative, accountable, and inclusive culture. You will be responsible for the professional growth of your direct reports and the broader operations team.
Financial and Budgetary Management
Assume full P&L responsibility for the sterile operations division. Lead the development of annual operating and capital budgets, meticulously manage expenditures, and drive initiatives to improve cost-effectiveness without compromising quality or safety. Present financial performance and forecasts to the executive team.
Client Project Management and Relations
Serve as a senior operational point of contact for key clients, fostering strong, transparent, and trust-based partnerships. Participate in client governance meetings, provide strategic operational insights, and ensure that client projects are executed flawlessly from a manufacturing perspective.
Technology Transfer and New Product Introduction (NPI)
Oversee the seamless technical transfer of new client products into the manufacturing facility. Collaborate closely with Process Development, Manufacturing Science & Technology (MS&T), Quality, and Project Management teams to ensure that new processes are robust, scalable, validated, and successfully implemented.
Environmental, Health, and Safety (EHS) Leadership
Promote and enforce a ‘safety-first’ culture across all operations. Ensure full compliance with all local, state, and federal EHS regulations, and champion programs that proactively identify and mitigate risks to employee health and the environment.
Requirements for the VP Sterile Operations with a Contract Injectables Manufacturer– Raleigh, NC
The ideal candidate will be a seasoned executive with a proven track record of leadership in a sterile manufacturing environment.
Educational Background
A Bachelor of Science (B.S.) degree in Engineering (Chemical, Mechanical, or Biomedical), Chemistry, Biology, Pharmacy, or a related life sciences field is required. An advanced degree (M.S., M.B.A., or Ph.D.) is highly preferred.
Professional Experience
- A minimum of 15 years of progressive experience within the pharmaceutical or biopharmaceutical industry.
- At least 10 years in a significant leadership role (e.g., Director, Senior Director, VP) with direct oversight of sterile/aseptic manufacturing operations.
- Must-have experience working within a Contract Development and Manufacturing Organization (CDMO) or Contract Manufacturing Organization (CMO), demonstrating a deep understanding of the client-service model.
- A demonstrable track record of successfully leading manufacturing operations through multiple regulatory inspections (e.g., FDA Pre-Approval Inspections, general cGMP inspections).
Technical Expertise
- Expert-level knowledge of aseptic processing, sterile fill-finish operations, isolator technology, restricted access barrier systems (RABS), terminal sterilization, and lyophilization.
- In-depth, current knowledge of global regulatory requirements, including FDA 21 CFR Parts 210/211, EU GMP Annex 1, and ICH guidelines.
- Substantial experience with technology transfer, process validation (PV), cleaning validation, and equipment qualification.
Leadership and Business Acumen
- Exceptional leadership presence with the ability to inspire, influence, and motivate large, cross-functional teams.
- Proven financial acumen with experience managing a P&L, developing multi-million dollar budgets, and overseeing large-scale capital projects.
- A strategic and analytical mindset, capable of translating high-level corporate goals into tangible, actionable operational plans.
- Strong project management skills and a demonstrated ability to drive operational excellence initiatives using Lean/Six Sigma principles. A certification (e.g., Green Belt, Black Belt) is a significant plus.
- Outstanding communication and interpersonal skills, with the ability to effectively present complex information to clients, regulatory bodies, and executive leadership.
Benefits & Perks Offered
Our client is committed to attracting and retaining top executive talent by offering a highly competitive and comprehensive compensation and benefits package, including:
Executive Compensation Package
A highly competitive base salary, a significant annual performance-based bonus, and a meaningful long-term incentive plan (equity/stock options).
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance plans for you and your eligible dependents; Health Savings Account (HSA) and Flexible Spending Account (FSA) options; and a robust Employee Assistance Program (EAP).
Retirement and Financial Planning
A 401(k) retirement savings plan with a generous company match to help you prepare for your future.
Work-Life Balance
A generous paid time off (PTO) policy, numerous company-paid holidays, and a commitment to supporting a healthy work-life integration.
Relocation Support
A comprehensive, executive-level relocation package is available for the successful candidate and their family to move to the dynamic and desirable Raleigh, NC area.
Career Growth and Development
Ample opportunities for professional development, including support for attending industry conferences, executive coaching, and continuous learning.
How to Apply
This is a retained, exclusive search conducted by JRG Partners. If you are a visionary operations leader with the experience and passion to drive excellence in sterile manufacturing, we encourage you to apply. This is a rare opportunity to shape the future of a leading CDMO and make a lasting impact on the pharmaceutical industry.
To express your interest, please submit your resume and a cover letter for confidential consideration. You can learn more about our dedicated search capabilities by visiting the website for the JRG Partners’ Aseptic Manufacturing, Injectable Production & Sterile Operations practice.
Our client is an Equal Opportunity Employer (EOE) and is committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
