VP Quality Control Biologics – New Jersey, NJ

Are you a quality-driven leader with deep expertise in biologics manufacturing and regulatory compliance? We are seeking a Vice President of Quality Control to join a leading biopharmaceutical company in New Jersey, NJ. This executive role offers a unique opportunity to shape and lead quality strategies, drive best-in-class laboratory operations, and ensure consistent product excellence in a fast-paced, innovation-driven environment. If you’re passionate about biologics, quality systems, and team leadership, this role is for you.

Lead Quality Excellence in a Leading Biologics Facility in New Jersey

A cutting-edge biopharmaceutical organization based in New Jersey is looking for a Vice President of Quality Control (Biologics) to oversee and elevate its QC operations. The ideal candidate will bring deep knowledge of biologics manufacturing, analytical method validation, and cGMP compliance. With a strong background in managing QC labs and cross-functional collaboration, you’ll be instrumental in ensuring regulatory readiness, data integrity, and product quality across the pipeline. This is your opportunity to lead a high-performing team and help deliver transformative therapies to patients worldwide.

Key Responsibilities of the Vice President – Quality Control (Biologics)

Strategic Quality Leadership:
Develop and execute the overall quality control strategy for biologics operations, ensuring alignment with regulatory standards, company goals, and global quality expectations. Drive continuous improvement across QC systems to support high-quality biologic product development and commercialization.

Laboratory Oversight & Operations:
Lead and oversee all Quality Control laboratory operations, including raw material testing, in-process testing, release testing, and stability programs. Ensure laboratories are operating in full compliance with cGMP and regulatory requirements (FDA, EMA, etc.).

Regulatory Compliance & Inspection Readiness:
Maintain a state of constant audit and inspection readiness. Serve as a key liaison during regulatory inspections and external audits. Ensure timely resolution of observations and proactive mitigation of compliance risks.

Method Development & Validation:
Oversee analytical method transfer, development, validation, and troubleshooting for biologics testing. Collaborate with internal and external teams to ensure robust and phase-appropriate analytical methods.

Data Integrity & Documentation:
Ensure strict adherence to data integrity principles and cGMP documentation practices. Lead initiatives to improve data governance, electronic systems utilization, and transparent reporting.

Team Leadership & Talent Development:
Build, mentor, and retain a high-performing QC team. Promote a culture of accountability, technical excellence, and compliance. Provide clear goals, career development opportunities, and ongoing training for staff.

Cross-Functional Collaboration:
Work closely with Manufacturing, QA, Regulatory Affairs, R&D, and Supply Chain to support production timelines, batch release, and new product launches. Act as the QC representative in cross-functional initiatives and project teams.

Risk Management & Quality Systems Improvement:
Lead proactive risk assessments and implement corrective and preventive actions (CAPA) to prevent quality issues. Evaluate and enhance QC-related quality systems, including deviation management, OOS investigations, and change control.

Environmental Monitoring & Microbiology:
Oversee microbiological testing and environmental monitoring programs to ensure aseptic operations and sterility assurance for biologics manufacturing.

Budget Management & Resource Planning:
Develop and manage the QC department’s operational and capital budgets. Ensure appropriate resource allocation, lab capacity planning, and cost-effective operations while maintaining compliance and quality standards.

What the Client is Looking for in You

As the Vice President – Quality Control (Biologics), our client is seeking a results-driven, quality-focused executive with deep scientific expertise and a passion for operational excellence in biologics manufacturing. The ideal candidate is a seasoned leader who can elevate quality systems, ensure regulatory compliance, and contribute strategically to product development and commercialization.

Extensive Experience in Biologics Quality Control
You should have a strong background in biologics, with hands-on experience managing complex QC operations including analytical testing, microbiology, method development, and stability programs. Familiarity with cGMP regulations and global health authority expectations (FDA, EMA, etc.) is essential.

Proven Leadership in Regulated Environments
The client values executives who have successfully led high-performing QC teams in FDA-regulated environments. Experience preparing for and managing regulatory inspections, addressing audit findings, and maintaining inspection readiness is critical.

Technical Expertise & Analytical Problem-Solving
A deep understanding of biologics analytical methods, assay development, and product characterization is a must. You should bring a strong ability to troubleshoot analytical challenges, guide method transfers and validations, and ensure data integrity across labs.

Strategic and Operational Mindset
While strong technical skills are vital, the client also seeks someone who thinks strategically and leads with a broader business vision. You should be capable of optimizing QC operations, aligning quality goals with business objectives, and driving continuous improvement across the organization.

Cross-Functional Collaboration
The ideal candidate is a strong communicator and collaborator, capable of building trust and alignment with stakeholders across Manufacturing, QA, Regulatory Affairs, R&D, and Supply Chain. Your ability to represent QC perspectives in cross-functional forums is key to success.

Strong Leadership & Team Development Skills
You should be an inspiring leader with a demonstrated ability to build, mentor, and retain diverse QC teams. Experience developing talent, fostering accountability, and cultivating a culture of compliance and excellence is highly valued.

Regulatory and Inspection Savvy
You must be well-versed in managing pre-approval inspections (PAIs), routine regulatory inspections, and internal audits. The ability to proactively identify and mitigate compliance risks while fostering a culture of readiness is essential.

Commitment to Quality, Compliance & Innovation
The client seeks a VP who not only ensures rigorous quality standards but also drives innovation in analytical approaches, automation, and digital transformation in QC labs.

FAQs About the Role – Vice President – Quality Control (Biologics)

1. What are the key responsibilities of the VP of Quality Control?
As Vice President – Quality Control (Biologics), you will lead the QC function across analytical testing, microbiology, method development, and stability programs. You’ll oversee laboratory operations, ensure compliance with global regulatory requirements, lead inspection readiness initiatives, and drive continuous improvement in quality systems and lab performance. This role also plays a strategic part in product development and commercialization efforts.

2. What qualifications and experience are required for this position?
The ideal candidate should have a Ph.D., MS, or BS in a relevant scientific discipline (e.g., Biochemistry, Molecular Biology, Analytical Chemistry), along with 15+ years of experience in Quality Control within biologics or biopharma environments. Proven leadership in cGMP-regulated settings, regulatory inspection experience (FDA, EMA), and deep technical expertise in analytical method development and validation are essential.

3. What leadership qualities are important for this role?
The client is seeking a strategic leader with strong decision-making skills, a hands-on approach to quality management, and the ability to build and lead high-performing teams. Excellent communication, collaboration across cross-functional teams, and a culture of accountability and compliance are critical. You should also be capable of influencing at executive levels and mentoring scientific and operational staff.

4. What challenges can I expect in this role?
You may encounter challenges related to regulatory scrutiny, evolving analytical technologies, global compliance standards, and the integration of digital and automated QC systems. Scaling QC operations to support product launches and ensuring data integrity across teams are also key responsibilities that require strong oversight and adaptability.

5. How does this role impact the company’s success?
This position plays a critical role in ensuring product quality, regulatory compliance, and successful product approvals. Your contributions will support patient safety, regulatory milestones, and business continuity. Strong QC leadership is vital to building stakeholder confidence and enabling scalable, compliant manufacturing operations.

6. What is the work environment and company culture like?
The company offers a collaborative, innovative, and compliance-focused environment. You’ll work closely with leaders across QA, Manufacturing, R&D, and Regulatory Affairs. The organization values scientific rigor, continuous improvement, and a proactive approach to risk management. Leaders are empowered to shape culture, drive operational excellence, and influence corporate success.

What Remuneration Can You Expect from This Job?

As the Vice President of Quality Control – Biologics in New Jersey, NJ, you can expect a highly competitive executive compensation package designed to attract top-tier leadership talent in the biopharmaceutical industry. The remuneration typically includes the following components:

1. Base Salary

The base salary for a VP of Quality Control in the biologics sector varies based on company size, product pipeline, and organizational complexity. In a mid-to-large-scale biopharmaceutical company, the annual base salary generally ranges from $220,000 to $350,000, with some organizations offering higher pay for exceptional expertise and leadership.

2. Annual Performance Bonuses

Most VP-level roles include annual performance-based bonuses tied to strategic goals such as regulatory compliance, product quality, team performance, and operational efficiency. These bonuses typically range from 20% to 50% of the base salary and are based on both individual and company performance.

3. Equity or Stock Options

To align long-term interests, many biopharma companies offer equity-based incentives, such as restricted stock units (RSUs) or stock options, especially at the executive level. These incentives can significantly enhance total compensation and reflect the company’s growth and valuation over time.

4. Long-Term Incentive Plans (LTIPs)

Some organizations offer long-term incentive plans that reward consistent performance, leadership stability, and strategic contributions over a multi-year period. These plans may include cash bonuses, additional equity, or deferred compensation.

5. Executive Benefits and Perks

As a VP, you’ll typically be entitled to a comprehensive executive benefits package, which may include:

Premium health, dental, and vision insurance
401(k) or pension plan with company match
Executive wellness programs
Paid time off and sabbatical options
Company-provided vehicle or car allowance
Continuing education and leadership training stipends

6. Signing Bonuses & Relocation Support

To secure top talent, companies may offer signing bonuses ranging from $25,000 to $100,000, and relocation assistance for candidates moving to New Jersey. These incentives help offset the transition and signal the organization’s commitment to your onboarding.

Total Compensation Potential

When you combine the base salary, bonus opportunities, equity, and incentive programs, total annual compensation for a VP of Quality Control in Biologics can range from $300,000 to $600,000+, depending on company size and success metrics. In high-growth or publicly traded companies, this number may be significantly higher.

How to Apply

If you are an experienced and quality-focused leader with a proven track record in biologics and pharmaceutical manufacturing, we encourage you to apply for the Vice President of Quality Control – Biologics role in New Jersey, NJ. This is a pivotal opportunity to shape quality systems, ensure regulatory excellence, and drive product integrity within a dynamic and mission-driven biopharma organization.

To apply, please submit your resume and a cover letter highlighting your experience in:

Leading Quality Control in biologics or sterile manufacturing
Managing GMP-compliant laboratories and regulatory inspections (FDA, EMA, etc.)
Developing and implementing robust quality systems
Building and mentoring high-performing QC teams
Driving data integrity, analytical method validation, and cross-functional collaboration

This executive role offers the chance to directly influence product quality and patient outcomes, playing a critical leadership role in the development and delivery of life-saving biologic therapies. Take the next step in your career and help set the gold standard in biologics quality.

Apply today to join a leading biopharmaceutical company as Vice President of Quality Control in New Jersey!

For more information or to explore related executive opportunities, visit our Biologics Recruiting Experts Page.

Job Category: Biologics

Job Type: Full Time

Job Location: New Jersey

VP Quality Control Biologics – New Jersey, NJ