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Quality Assurance Operations Manager Jobs (NOW HIRING)

FullSteam

QA Supervisor (Cheese Department)

Fontana, CA · On-site

$70K/yr

  • Medical

  • Dental

  • Life

... Manager FLSA Status: Exempt Shift: TBD Salary: $70,304 per year Benefits: * Medical * Dental * AD&D Insurance Job Summary The Cheese QA Supervisor oversees daily quality assurance operations within ...

krg technology inc

QA MANAGER

Omaha, NE · On-site

Job Title : QA MANAGER Location: Omaha, NE Duration: FullTime Understand and analyze products ... Achieves quality assurance operational objectives by contributing information and analysis to ...

Retro

Senior Quality Operations Manager

Redwood City, CA

  • Medical

  • Dental

  • Vision

  • Retirement

In this role, you will own core QA operational processes, ensure the Quality Management System functions effectively as activity increases, and support compliant, phase-appropriate execution across ...

Retro

Senior Quality Operations Manager

Redwood City, CA

$175K - $190K/yr

In this role, you will own core QA operational processes, ensure the Quality Management System functions effectively as activity increases, and support compliant, phase-appropriate execution across ...

Perrigo

Manager Quality Assurance

Eau Claire, WI

The Quality Assurance Manager ensures that all infant formula products are produced, tested, stored ... This role leads daily QA operations and partners closely with Manufacturing, Laboratory ...

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Quality Assurance Operations Manager information

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How much do quality assurance operations manager jobs pay per year?

As of Aug 16, 2026, the average yearly pay for quality assurance operations manager in the United States is $118,074.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,000.00 and $144,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a quality assurance operations manager, and why are they important?

A Quality Assurance Operations Manager needs expertise in quality control principles, regulatory compliance, and process improvement, often supported by a degree in a relevant field and experience in quality management systems. Familiarity with tools like ISO standards, Six Sigma, CAPA systems, and audit software is typically required. Strong leadership, attention to detail, and effective communication enable success in managing teams and driving quality initiatives. These skills ensure products consistently meet standards, minimize risk, and enhance organizational efficiency.

What is quality assurance in operations management?

Quality assurance in operations management involves systematic processes to ensure products or services meet specified standards and customer expectations. It includes activities like process audits, defect prevention, and continuous improvement, often supported by tools such as quality management systems (QMS) and certifications like ISO 9001. The role of a Quality Assurance Operations Manager is to oversee these activities to maintain consistent quality across operations.

What does a quality assurance operations manager do?

A Quality Assurance Operations Manager oversees the quality assurance processes within an organization to ensure that products or services meet established standards of quality, reliability, and performance. They develop and implement quality control policies, lead a team of QA specialists, and coordinate with other departments to address quality issues. Their responsibilities also include conducting audits, analyzing quality data, and driving continuous improvement initiatives to enhance product or service quality.

What is the difference between Quality Assurance Operations Manager vs Quality Assurance Specialist?

AspectQuality Assurance Operations ManagerQuality Assurance Specialist
CredentialsTypically requires a bachelor's degree in quality management, engineering, or related field; certifications like ASQ CQE or CQA are commonUsually holds a bachelor's degree in quality assurance, engineering, or related area; certifications like ASQ CQA are beneficial
Work EnvironmentOversees QA teams, manages processes, and ensures compliance across departments in manufacturing or service industriesPerforms testing, inspections, and audits to ensure product or service quality, often working hands-on with products or data
Employer & Industry UsageFound in manufacturing, healthcare, and tech companies, focusing on operational quality managementCommon in manufacturing, software, and healthcare sectors, focusing on quality testing and compliance

The main difference is that the Quality Assurance Operations Manager oversees QA processes and teams, focusing on operational management, while the Quality Assurance Specialist performs hands-on testing and inspections to ensure quality standards are met.

What are some common challenges a quality assurance operations manager faces when implementing new quality protocols across teams?

One of the main challenges Quality Assurance Operations Managers encounter is ensuring consistent adoption of new protocols across multiple departments. Resistance to change, varying levels of quality awareness, and differences in team workflows can make standardization difficult. Effective communication, comprehensive training, and continuous monitoring are essential to address these challenges. Collaborating closely with production, engineering, and regulatory teams helps to preempt potential issues and foster a culture of quality throughout the organization.
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Quality Assurance Operations Manager jobs near you
Infographic showing various Quality Assurance Operations Manager job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $118,074 per year, or $56.8 per hour.

Director/Senior Director, GMP Quality Assurance Operations

Socket.dev

Waltham, MA • On-site

$200 - $260/hr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 4 days ago

Job description

Company overview

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapiesas single agentsand as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be responsible for providing strategic and hands-on GMP Quality leadership for manufacturing activities supporting the lead biologics program and future pipeline growth. Partnering closely with the GMP Quality and cross-functional Technical Operations teams, you will ensure reliable clinical supply while building the Quality infrastructure needed to successfully advance programs into late-stage development and commercialization.

You will provide Quality oversight across master cell bank, working cell bank, drug substance, drug product, and finished goods within a global outsourced manufacturing network. You will bring deep biologics experience spanning clinical through late-stage development, with demonstrated expertise supporting clinical supply, technology transfer, CDMO selection and management, process validation/PPQ, and commercial readiness, including BLA support.

Responsibilities

  • Lead and execute GMP Quality Assurance activities for assigned development programs, including manufacture of master cell bank, working cell bank, drug substance, and drug product/finished goods, in alignment with Crescent’s Quality System, across a growing portfolio of clinical studies within a platform program.
  • Own batch record review, disposition, and release activities for a high volume of clinical resupply batches, in accordance with delegated authority and established procedures; support QP/RP interactions and governance where applicable, ensuring quality operations keep pace with growing supply demand.
  • Lead QA input into CDMO selection, onboarding, and ongoing management for assigned programs, including risk-based qualifications, audits, Quality Agreements, issue management, and performance monitoring, with an eye toward late-stage and commercial fit.
  • Lead and manage QA activities related to tech transfer, scale-up, process validation/qualification (facilities, utilities, equipment, PPQ, cleaning), and analytical method validation and transfer, positioning the program for successful PPQ execution and BLA readiness.
  • Execute and support core GMP quality systems, including deviations, investigations, CAPAs, change control, batch review, CPV, OOS/OOT/OOE management, and stability programs, ensuring timely and compliant closure.
  • Partner closely with CMC, Technical Operations, Analytical Sciences, Quality Control, and Supply Chain, and Regulatory teams to embed quality oversight into program execution and manufacturing timelines.
  • Provide QA input to CMC development and regulatory strategies, including phase -appropriate review and approval of applicable development deliverables and review and contribution to CMC sections of INDs, IMPDs, BLAs, and MAAs, and support responses to health authority inquiries.
  • Support implementation and use of electronic quality systems (eQMS, DMS, LMS), ensuring compliance with Part 11 / Annex 11 and data integrity expectations for GMP records.
  • Contribute to quality risk management activities by identifying, assessing, and escalating GMP-related risks; propose mitigation strategies in partnership with Quality Management.
  • Support quality oversight of dose expansion cohorts, including combination regimens involving standard of care product, ensuring appropriate quality controls and documentation across the combined supply chain.
  • Support GDP-related interfaces for assigned programs, including labeling/packaging operations, temperature excursions, complaints, deviations, returns, managing QP Declaration and Certification activities, QP release coordination, and traceability requirements as applicable.
  • Track and report program-level GMP quality metrics and trends; support continuous improvement initiatives across manufacturing and supply operations.
  • Mentor junior QA staff and external consultants as applicable, contributing to a strong quality culture grounded in collaboration, accountability, and continuous learning.
  • Stay current on evolving GMP regulations, guidance, and industry best practices, and proactively apply learnings to Crescent’s operations.

Education & Experience

  • Bachelor’s degree in life sciences or a related discipline; advanced degree preferred.
  • Director: 8-10 years of progressive experience in GMP Quality Assurance within biotech or pharmaceutical development.
  • Senior Director: 10-12 years of progressive experience with demonstrated leadership in GMP QA Operations.
  • Strong working knowledge of global GMP regulations and guidance (FDA, EMA, ICH) and phase-appropriate application for biologics spanning clinical-stage through late-stage development.
  • Deep, hands-on experience supporting biologics manufacturing, including drug substance and drug product operations, from clinical through late-stage/commercial; experience with ADCs or complex modalities is a plus.
  • Proven experience providing QA oversight of CDMOs, including selection, audits, investigations, change management, and issue resolution; experience leading tech transfers and supporting PPQ and BLA filings strongly preferred.
  • Experience supporting regulatory submissions and inspections, including preparation of CMC-related documentation and responses to health authority questions.
  • Solid understanding of validation principles, batch release processes, and analytical and stability programs.
  • Demonstrated ability to balance a high volume of ongoing clinical resupply and release activities with the strategic work of preparing a program for phase 3/commercial readiness.
  • Demonstrated ability to operate effectively in a highly outsourced, fast-paced development environment with evolving priorities.
  • Strong collaboration, communication, and influencing skills, with the ability to balance compliance rigor and development agility.
  • Hands-on, solutions-oriented mindset with the judgment to escalate issues appropriately and propose pragmatic, risk-based solutions.
  • Right attitude and aptitude for a small company environment—self-starting, comfortable with ambiguity and wearing multiple hats, and driven to get things done with both high quality and speed.
  • Willingness and ability to travel to CDMO and other supplier sites for PIP, PPQ execution, and other on-site quality activities as needed.
  • Commitment to fostering a culture of quality, integrity, inclusion, and continuous improvement.

What We Offer

  • Opportunity to join a mission-driven team where you\'ll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
  • Competitive compensation, including base salary, performance bonus, and equity
  • 100% employer-paid benefits package
  • Flexible PTO; also, two, one-week company-wide shutdowns each year
  • A commitment to your professional development, with access to resources, mentorship, and growth opportunities

Salary Range

The salary range for this position is $200,000 to $260,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
Additional Description for Pay Transparency:
The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

Please note:

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

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