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Vp Cmc Jobs (NOW HIRING)

SAB

Vice President Quality Assurance

Sioux Falls, SD · On-site

$275K - $310K/yr

The VP of QA is a key executive leader responsible for building, scaling, and overseeing SAB ... This leader will partner closely with QC, CMC, Manufacturing, Clinical Development, Regulatory ...

Critical Innovations

Director of CMC

Lawndale, CA · Hybrid

Reports to: VP of Research Duties and Responsibilities: The responsibilities of the Director of CMC typically include: Analytical Development Oversight * Oversee development, optimization ...

EPM Scientific

VP/SVP Global Regulatory Affairs

Boston, MA · On-site +1

$163K - $215.10K/yr

The SVP, Global Regulatory Affairs will serve as the senior-most regulatory leader, responsible for ... Collaborate deeply with Clinical, CMC, Biomarker, Program Management, and Commercial Planning.

Loyal

Vice President, Regulatory Affairs

$153.50K - $202.70K/yr

About the role Loyal is seeking a Vice President, Regulatory Affairs to lead all aspects of the ... A strong CMC regulatory background is essential. The ideal candidate brings deep expertise in small ...

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Vp Cmc information

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$43.5K

$157.5K

$277.5K

How much do vp cmc jobs pay per year?

As of May 29, 2026, the average yearly pay for vp cmc in the United States is $157,532.00, according to ZipRecruiter salary data. Most workers in this role earn between $115,000.00 and $190,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a VP CMC (Vice President, Chemistry, Manufacturing, and Controls), and why are they important?

To thrive as a VP CMC, you need deep expertise in pharmaceutical development, regulatory compliance, and process optimization, typically supported by an advanced degree in chemistry, chemical engineering, or a related field. Familiarity with regulatory submission systems, quality management platforms, and CMC documentation tools is essential. Leadership, strategic thinking, and excellent communication are critical soft skills for guiding cross-functional teams and aligning stakeholders. These skills ensure efficient drug development, regulatory approval, and successful product launches in a highly regulated industry.

What are the typical challenges a VP of CMC faces when scaling up manufacturing for clinical trials and commercial launch?

A VP of CMC (Chemistry, Manufacturing, and Controls) often encounters challenges in scaling up manufacturing processes, including ensuring consistent product quality, meeting strict regulatory requirements, and managing timelines across multiple stakeholders. Coordinating between R&D, manufacturing, and quality teams is crucial to address technical hurdles and maintain compliance. Additionally, adapting to evolving regulations and managing supply chain complexities are key responsibilities, especially when progressing from clinical trials to commercial production.

What is a VP CMC?

A VP CMC (Vice President of Chemistry, Manufacturing, and Controls) is a senior executive responsible for overseeing all aspects of drug development related to chemistry, manufacturing processes, and quality controls. This role typically exists in pharmaceutical or biotechnology companies and ensures that products are developed, manufactured, and controlled according to regulatory standards. The VP CMC collaborates with research, regulatory, and commercial teams to ensure efficient and compliant product development from early research through commercialization. They are also responsible for managing teams, budgets, and timelines to meet critical milestones.

What is the difference between Vp Cmc vs Regulatory Affairs Manager?

AspectVp CmcRegulatory Affairs Manager
CredentialsAdvanced degrees in life sciences, experience in CMC developmentBachelor's or Master's in life sciences, regulatory certifications
Work EnvironmentStrategic leadership in R&D and manufacturingRegulatory compliance, documentation, and submissions
Industry UsagePharmaceutical and biotech companies, overseeing CMC activitiesRegulatory agencies, pharmaceutical companies, ensuring compliance

The Vp Cmc focuses on overseeing chemistry, manufacturing, and controls (CMC) processes at a strategic level, ensuring product quality and compliance. Regulatory Affairs Managers handle regulatory submissions and compliance activities. While both roles require industry knowledge, Vp Cmc roles are more senior and strategic, whereas Regulatory Affairs Managers focus on regulatory documentation and compliance tasks.

What cities are hiring for Vp Cmc jobs? Cities with the most Vp Cmc job openings:
What are the most commonly searched types of Cmc jobs? The most popular types of Cmc jobs are:
What states have the most Vp Cmc jobs? States with the most job openings for Vp Cmc jobs include:
What job categories do people searching Vp Cmc jobs look for? The top searched job categories for Vp Cmc jobs are:
Vp Cmc jobs near you
Infographic showing various Vp Cmc job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 62% Full Time, 31% Part Time, and 6% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $157,532 per year, or $75.7 per hour.
Vice President Quality Assurance

Vice President Quality Assurance

SAb Biotherapeutics, Inc

Sioux Falls, SD • On-site

$275K - $310K/yr

Full-time

Posted 22 days ago

Job description

The VP of QA is a key executive leader responsible for building, scaling, and overseeing SAB's global Quality Assurance organization as the company advances from late-stage clinical development toward commercialization. Reporting to the Senior Vice President of Regulatory Affairs & Quality Assurance, this role provides strategic leadership across GxP functions, ensures compliance with FDA, EMA, MHRA, and ICH requirements, and drives a culture of quality across the company.
The VP of QA will lead all aspects of Quality Assurance Systems, GxP compliance, clinical and CMC quality oversight, supplier and manufacturing quality, and inspection readiness. This leader will partner closely with QC, CMC, Manufacturing, Clinical Development, Regulatory Affairs, and executive leadership to ensure SAB's programs meet global regulatory expectations and support successful Phase 3 execution and global regulatory filings.
NOTE This is an onsite role in Sioux Falls, SD. Relocation is available for this role.
Key Responsibilities (include but are not limited to):
  • Quality Leadership & Strategy
    • Define and drive the company's QA vision, strategy, and culture in alignment with SAB's clinical and commercial objectives. This position will be responsible for ensuring scalability of the QA structure to support transition from pre-commercial to a commercial-ready organization.
    • Establish QA objectives, metrics, and governance to ensure cross-functional accountability and operational excellence.
    • Serve as SAB's senior authority on GxP compliance and global regulatory expectations.
  • Quality Systems & Compliance
    • Oversee development, implementation, and continuous improvement of Quality Systems aligned with US and international regulatory requirements.
    • Identify gaps and lead building systems and processes critical to resolve identified gaps to assure "approved on first filing" from the QA perspective
    • Ensure robust training programs are in place to support GxP activities across the organization.
    • Maintain and evolve the Quality Manual, deviation/CAPA management, change control, documentation standards, and data integrity programs.
  • GxP Oversight & Product Quality
    • Provide leadership across GxP domains including Quality Assurance, Quality Operations, Clinical Quality, Supplier Quality, and Quality Control.
    • Ensure compliant and timely release of clinical materials, including oversight of manufacturing and testing of biologics.
    • Evaluate and approve Quality sections of regulatory submissions (INDs, CTAs, BLAs, MAAs) and associated compliance documentation.
  • Inspection Readiness & Audit Management
    • Lead global inspection readiness activities and serve as executive lead during regulatory inspections and audits.
    • Oversee internal and external audit programs, including CMOs, CROs, and critical suppliers.
    • Ensure timely, compliant responses to regulatory observations (e.g., FDA 483s, deficiency letters) and drive effective remediation.
  • Cross-Functional Partnership
    • Partner with QC, CMC, Manufacturing, Clinical Development, and Regulatory Affairs to ensure Quality considerations are integrated early into program strategy.
    • Define Quality Assurance staffing needs and build a high-performing team capable of supporting late-stage development and commercialization.
    • Drive continuous improvement initiatives to enhance efficiency, compliance, and operational maturity.
  • Other Responsibilities
    • Ensure global GxP compliance across all functions.
    • Support lifecycle management and readiness for Phase 3 and commercial scale.
    • Perform additional duties as assigned.

Supervisory Responsibilities:
This position has supervisory responsibilities.
Education/Experience/Skills:
  • Bachelor's degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) strongly preferred.
  • 15+ years of progressive Quality leadership experience in the pharmaceutical/biotech industry.
  • Demonstrated success leading Quality organizations through late-stage development (Phase 2b/3) and global regulatory submissions.
  • Deep knowledge of global GxP requirements, Quality Systems, and biologics development.
  • Must have experience with INDs, CTAs, BLAs, and/or MAAs filings
  • Must have experience with interactions and audits conducted by FDA, EMA, MHRA, and other global authorities in the QA capacity.
  • Must have led at least one BLA/MAA submission and at least one audit in the QA capacity.
  • Proven ability to lead cross-functional teams and influence at the executive level.
  • Experience managing CMOs, CROs, and external partners.
  • Strong communication skills, attention to detail, and ability to drive change across functions.
  • Commitment to operational excellence and continuous improvement.
Working Environment and Travel:
  • Ability to travel up to 20%, including international travel as needed.
  • Normal office working conditions.
ADA
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

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