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Quality Assurance Cdmo Jobs (NOW HIRING)

Actalent

Quality Assurance Associate

San Diego, CA

Help maintain compliance with ISO standards and support quality system activities within a regulated IVD/CDMO environment. * Apply knowledge of 21 CFR 820 regulations to daily quality assurance ...

New

Tri-Pac Inc

Quality Assurance Auditor

South Bend, IN · On-site

Quality Assurance Auditor Hubot - Tri Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is ...

SpectronRx

QA Specialist

Bunker Hill, 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 ...

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 ...

PHARMALOGIC HOLDINGS

PR · On-site

... CDMO) with radiopharmacies across North America. We are passionate about expanding the power of ... As the Quality Assurance Specialist, you will play a vital role in the PharmaLogic quality program ...

INCOG

Senior QA Validation Specialist

Fishers, IN

$77K - $106K/yr

The Senior Quality Validation Specialist provides Quality Assurance oversight of validation ... Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with ...

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Quality Assurance Cdmo information

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How much do quality assurance cdmo jobs pay per hour?

As of Jul 26, 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 are the key skills and qualifications needed to thrive as a Quality Assurance CDMO, and why are they important?

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 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 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.

More about Quality Assurance Cdmo jobs
What cities are hiring for Quality Assurance Cdmo jobs? Cities with the most Quality Assurance Cdmo job openings:
What states have the most Quality Assurance Cdmo jobs? States with the most job openings for Quality Assurance Cdmo jobs include:
What job categories do people searching Quality Assurance Cdmo jobs look for? The top searched job categories for Quality Assurance Cdmo jobs are:
Quality Assurance Cdmo jobs near you
Infographic showing various Quality Assurance Cdmo job openings in the United States as of July 2026, with employment types broken down into 95% Full Time, and 5% Contract. Highlights an 95% In-person, and 5% Remote job distribution, with an average salary of $93,338 per year, or $44.9 per hour.
Manager, Quality Assurance

Manager, Quality Assurance

Rhythm Pharmaceuticals

Boston, MA • On-site

Full-time

Posted 8 days ago

Job description

­­Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions, and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. 
Opportunity Overview
Rhythm is looking for a Manager Quality Assurance (QA) to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution of Rhythm clinical products. This is an individual contributor management-level role within a CDMO dependent Quality organization. It requires solid technical expertise in sterile pharmaceutical manufacturing, strong CDMO relationship management skills, and fluency in the regulatory expectations for clinical-stage parenteral products. The successful candidate will operate with a high degree of autonomy and will partner closely with CMC development, Regulatory Affairs, Clinical Supply Chain, and CDMO Quality and manufacturing teams. The Manager QA will report to the Director, CMC QA, based in The United States, while supporting and liaising with global functions at Rhythm.
Responsibilities and Duties
  • Serve as the quality contact for external manufacturing partners producing sterile drug products, establishing and maintaining quality oversight of clinical manufacturing activities.
  • Manages clinical lot disposition for sterile drug product, including review of batch records, analytical results, and compliance with Regulatory Dossiers.
  • Responsible for the review and approval of process validation documents, protocols and reports, Master Batch Records and Executed Batch Records at the Contract Development and Manufacturing Organization (CDMO).
  • Provides QA oversight during technology transfer activities for new clinical products moving into CDMO sites.
  • Monitors contract manufacturer performance through routine reviews, meetings, and quality metrics.
  • Utilizes GMP-regulated quality management systems, including document control, change control, deviations/complaints, and corrective and preventative actions (CAPAs).
  • Facilitates the creation, review, and approval of relevant SOPs and work instructions relevant to CMC activities.
  • Provides QA support during CDMO audits, including participating in audit execution.
  • Supports regulatory filings (e.g., Investigational New Drugs (INDs), Annual Reports, Stability Reports) by reviewing data, ensuring compliance with regulatory procedures.

Qualifications and Skills
Required
  • Bachelor’s degree in a scientific discipline (Chemistry, Biology, Engineering, or related field)
  • A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in supporting manufacturing of sterile products.
  • Demonstrated experience providing sponsor-side quality oversight of CDMOs for sterile drug products, including batch record review, batch disposition, deviation management, and quality governance.
  • Working knowledge of aseptic processing, media fills, environmental monitoring, and sterility as applied in a CDMO model.
  • Strong understanding of cGMP regulations including FDA CFR Parts 210/211, EU Annex 1, ICH Q7, Q8, Q9, and Q10.
  • Detail oriented with strong organizational skills and the ability to manage multiple clinical programs and CDMO relationships simultaneously.
  • Self-directed and comfortable with a high degree of autonomy in a small-time, high-accountability environment.

Preferred 
  • Experience with technology transfer of sterile Drug Products into new CDMO sites.
  • Experience with lyophilized products, pre-filled syringes, or other complex sterile dosage forms; experience in peptides is a plus.
  • ASQ Certified Quality Auditor (CQA) or similar.

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $110,000 - $165,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.  Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
  • We are committed to advancing scientific understanding to improve patients’ lives
  • We are inspired to tackle tough challenges and have the courage to ask bold questions
  • We are eager to learn and adapt
  • We believe collaboration and ownership are foundational for our success
  • We value the unique contribution each individual brings to furthering our mission

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