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Quality Assurance Cdmo Jobs (NOW HIRING)

GenScript/ProBio

Head of US Quality Assurance

Pennington, NJ · On-site

$190K - $250K/yr

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to ... The Head of Quality Assurance (QA) is responsible for leading the US Quality Assurance organization ...

GenScript/ProBio

Head of US Quality Assurance

Pennington, NJ · On-site

$190K - $250K/yr

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to ... The Head of Quality Assurance (QA) is responsible for leading the US Quality Assurance organization ...

Pyramid Laboratories Inc

QA Specialist

Costa Mesa, CA · On-site

$65K - $75K/yr

The QA Specialist is responsible for independently conducting thorough review of batch production ... CDMO environment. PRINCIPAL DUTIES: Batch Record Review * Independently review executed batch ...

Pyramid Laboratories Inc

QA Specialist

Costa Mesa, CA · On-site

$65K - $75K/yr

The QA Specialist is responsible for independently conducting thorough review of batch production ... CDMO environment. PRINCIPAL DUTIES: Batch Record Review * Independently review executed batch ...

adareps

Quality Assurance Specialist

Vandalia, OH

... CDMO) with locations across North America and Italy. We offer a wide range of manufacturing ... Position Quality Assurance Specialist Location Vandalia, OH Summary The Quality Assurance ...

SpectronRx

QA Specialist

Indianapolis, IN · On-site

$27 - $30/hr

Quality Assurance Specialist COMPANY OVERVIEW SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana, and production locations in South Bend ...

Abzena Inc.

QA Operations Supervisor

San Diego, CA · On-site

$100K - $120K/yr

More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Quality Assurance Operations Supervisor is responsible for leading Quality ...

Actalent

Senior Quality Assurance Consultant

Greenville, NC · On-site

$79K - $108K/yr

Senior Quality Assurance Consultant The Senior Quality Assurance Consultant provides on-site ... Experience working with CMO/CDMO environments and external manufacturing partners. * Ability to ...

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Quality Assurance Cdmo information

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How much do quality assurance cdmo jobs pay per hour?

As of Sep 5, 2026, the average hourly pay for quality assurance cdmo in the United States is $44.87, according to ZipRecruiter salary data. Most workers in this role earn between $36.54 and $54.57 per hour, depending on experience, location, and employer.

What is a quality assurance CDMO?

A Quality Assurance CDMO refers to the quality assurance function within a Contract Development and Manufacturing Organization (CDMO). CDMOs are companies that provide services to pharmaceutical and biotechnology firms to develop and manufacture drugs. The Quality Assurance (QA) team ensures that all products and processes meet regulatory standards and client requirements. Their role includes overseeing compliance, conducting audits, reviewing documentation, and ensuring that manufacturing practices align with Good Manufacturing Practice (GMP) guidelines. This helps ensure the safety, efficacy, and quality of the pharmaceutical products produced.

What are the key skills and qualifications needed to thrive as a quality assurance CDMO?

To thrive as a Quality Assurance CDMO (Contract Development and Manufacturing Organization), you need a solid background in quality management systems, regulatory compliance (such as cGMP and ISO), and a degree in life sciences or a related field. Familiarity with tools like LIMS, CAPA systems, and experience with FDA or EMA audit processes is typically required. Strong attention to detail, problem-solving abilities, and effective communication are essential soft skills for this role. These competencies ensure that products meet stringent quality standards and regulatory requirements, safeguarding patient safety and organizational reputation.

What are some common challenges faced by quality assurance professionals in a CDMO environment, and how can they be addressed?

Quality Assurance professionals in a Contract Development and Manufacturing Organization (CDMO) often encounter challenges such as adapting to diverse client requirements, ensuring compliance with varying regulatory standards, and managing multiple projects simultaneously. To address these challenges, professionals must be adept at communicating with cross-functional teams, stay updated on evolving regulations, and develop strong project management skills. Emphasizing collaboration, continuous training, and proactive risk management can help QA professionals excel in this dynamic and fast-paced environment.

What is the difference between Quality Assurance Cdmo vs Quality Control Specialist?

AspectQuality Assurance CdmoQuality Control Specialist
CertificationsGMP, ISO, QA certificationsGMP, ISO, QC certifications
Work EnvironmentRegulatory compliance, process validation, documentationProduct testing, inspection, sample analysis
Industry UsagePharmaceutical, biotech, CDMO companiesManufacturing, production facilities

Quality Assurance Cdmo professionals focus on establishing and maintaining quality systems, ensuring compliance, and validating processes within CDMO settings. In contrast, Quality Control Specialists primarily perform product testing and inspection to verify quality. Both roles are essential in the pharmaceutical industry but differ in scope and responsibilities.

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Quality Assurance Cdmo jobs near you
Infographic showing various Quality Assurance Cdmo job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 14% Part Time, 3% Contract, and 1% Nights. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $93,338 per year, or $44.9 per hour.

Senior Director / Director, Quality Assurance

Attovia Therapeutics

San Carlos, CA • Remote

$210K - $280K/yr

Full-time

Re-posted 19 days ago

Job description

Attovia Therapeutics, Inc., is seeking a Sr. Director/Director of Quality Assurance to lead our quality function and oversee the performance of our external CDMO/CRO partners, who execute the majority of our GMP manufacturing, testing, and clinical activities. Reporting directly to the Quality Officer, this role is responsible for vendor quality management: qualifying and auditing CDMOs/CROs, negotiating and maintaining Quality Agreements, performing final quality review for batch release and lot disposition, and ensuring the company's internal Quality Management System (QMS) ties together all outsourced activity into a single, inspection-ready compliance picture. This role partners closely with CMC, Clinical Operations, Nonclinical/Preclinical Development, and Regulatory Affairs teams to ensure that our outsourced partners consistently deliver compliant, high-quality work that meets regulatory expectations and protects patient safety.
Key Responsibilities

Quality Strategy & Leadership

  • Working closely with the Quality Officer, CMC and clinical leadership, help set strategic direction and priorities for the quality function.
  • Represent Quality in regulatory strategy discussions, partnership/licensing diligence, and CDMO/CRO selection decisions.

CDMO Quality Oversight

  • Own quality oversight of CDMO activities, ensuring external partners operate in compliance with FDA, EMA, ICH, other applicable global regulations, and quality agreements.
  • In partnership with the CMC team, review and approve CDMO executed batch records, protocols, and quality documentation, confirming that all GMP requirements are met and that the quality record supporting each batch release decision is complete and traceable.
  • Drive proactive, risk-based oversight of CDMO quality systems, including deviations, investigations, CAPAs, change controls.
  • Support technology transfer and process validation activities performed at CDMO sites, including protocol/report review and approval to ensure manufacturing readiness for commercialization.

Clinical & Nonclinical CRO Oversight

  • Provide GCP/GLP quality oversight of CROs supporting clinical trials and nonclinical/toxicology studies to ensure all activities are conducted in strict compliance with FDA, EMA, ICH, other applicable global regulations, and quality agreements.
  • Working with Clinical QA consultant, review clinical quality documentation, monitor CRO audit findings, and track resolution of quality issues affecting trial data integrity.
  • Partner with Clinical Operations and Clinical QA consultants to ensure vendor oversight plans and risk-based monitoring approaches remain aligned with GCP requirements.
  • Provide support for clinical deviations and CAPA management. Identify and assess compliance risk and develop and implement risk mitigation measures.

Vendor Qualification, Audits & Quality Agreements

  • Drive vendor audits and qualification to ensure external partners maintain compliant, inspection-ready systems
  • Draft, negotiate, and maintain Quality Agreements defining roles, responsibilities, and quality standards between the company and each vendor.
  • Maintain the approved vendor list and associated risk assessments.

Quality Management System (QMS)

  • Working across internal functions and with external clinical/nonclinical QA consultants, drive the development of the internal QMS, including SOPs governing vendor oversight, deviations, CAPA, change control, document control, clinical operations, data management, pharmacovigilance, biostatistics, and training, and continuously improve it to support scaling clinical pipelines.
  • Maintain document control systems for controlled documents, quality agreements, and vendor quality records.
  • Training & Quality Culture
  • Develop and deliver GxP yearly training for internal staff, and champion a strong, risk-based quality culture across a small, cross-functional organization.
Basic Qualifications
  • Bachelor's or Master's degree in Life Sciences, Chemistry, Engineering, or a related technical discipline.
  • Experience in biologics, cell & gene therapy, or sterile injectable products.
  • 12+ years of Quality Assurance experience in the biotech/pharmaceutical industry, with direct experience managing outsourced GMP manufacturing and/or testing relationships (CDMO experience required).
  • Strong working knowledge of global GMP requirements including FDA, EMA, ICH guidelines, and applicable GCP/GLP regulations.
  • Demonstrated experience auditing contract manufacturers, testing labs, depot, or CROs, and negotiating Quality Agreements.
  • Experience reviewing batch records, CoAs, deviations, and change controls generated by external parties.
Preferred Qualifications
  • Strong technical writing, investigative, and risk-assessment skills.
  • Ability to work independently and manage multiple vendor relationships with minimal direct supervision
  • Prior experience as the sole or lead quality function at a small or virtual biotech company.
  • Familiarity with electronic QMS platforms (e.g., Veeva QMS, MasterControl, TrackWise).
  • Experience supporting a pre-approval inspection (PAI) or BLA/NDA filing.
About Attovia

Attovia™ is a clinical-stage biopharmaceutical company developing next-generation biotherapeutics for immune-mediated diseases with high unmet need.  Our product candidates are internally discovered using our proprietary ATTOBODY™ platform, an evolution-driven, high-throughput biologics platform that enables the rapid discovery and creation of diverse biparatopic complex biologics.  Our pipeline spans chronic pruritic diseases, inflammatory skin diseases, inflammatory bowel disease, and other immune-mediated conditions.

Our culture is centered around five core pillars: 
  •    Integrity 
  •    Learning & Growth 
  •    Drive for Excellence 
  •    Innovation 
  •    Teamwork & Collaboration 
 
We take pride in fostering a strong team and dynamic work environment, and we are seeking individuals who align with our values and contribute to a positive and impactful workplace.   
 
Attovia is located in San Carlos, CA.
 
Attovia is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, or veteran or disability status.  
 
Learn more about Attovia: www.attovia.com

Leveling and salary is commensurate with experience.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.