Quality Assurance Manager

Metric Bio; California (MO); On-site; USD 110,000 - 145,000; Full time

Job summary

An innovative company in the biopharmaceutical sector is seeking a Quality Assurance Manager/Senior QA Specialist to ensure compliance and operational excellence in a GMP-regulated environment. This role involves overseeing quality systems, conducting audits, and fostering a culture of quality across departments. The ideal candidate will have a strong background in GMP regulations, excellent analytical skills, and the ability to manage multiple priorities. Join a forward-thinking team dedicated to maintaining the highest standards in pharmaceutical manufacturing and make a significant impact on quality assurance practices.

Benefits

401(k)

Medical insurance

Qualifications

• 5-10 years in a GMP-regulated biopharmaceutical environment.
• Experience with biologics, especially antibodies, is a plus.

Responsibilities

• Support site quality and compliance initiatives in a GMP environment.
• Author and review SOPs, protocols, and regulated documentation.

Skills

GMP regulations knowledge

Analytical thinking

Problem-solving

Effective communication

Attention to detail

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Office Suite

Job description

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This range is provided by Metric Bio. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$110,000.00/yr - $145,000.00/yr

Direct message the job poster from Metric Bio

Global CDMO recruitment specialist – APAC expert

Metric Bio are partnered with a world leading CDMO in the large molecule space, searching for a Quality Assurance Manager/Senior QA Specialist.

As a part of the QA team, you will support site quality and compliance initiatives in a GMP-regulated environment. This role plays a key part in ensuring operational excellence and regulatory compliance by contributing to quality system oversight, audit readiness, and fostering a culture of quality across all departments.

• Author, review, and approve SOPs, protocols, reports, and regulated documentation to ensure compliance with applicable regulations and international standards.
• Evaluate and support continuous improvement of Quality Systems and procedures.
• Support the execution and maintenance of internal and external audit programs.
• Assist in managing client, internal, and regulatory inspections.
• Lead backroom activities and logistics during audits and inspections.
• Act as scribe and liaison for auditors and inspectors.
• Coordinate, perform, and monitor site risk assessments and Quality metrics.
• Support discrepancy reports, including deviations, CAPAs, and complaints.
• Assist in the administration of electronic Quality Management Systems (eQMS).
• Foster strong cross-functional communication and collaboration.
• Travel as needed to support audits, training, and conferences.
• Promote and demonstrate professionalism and ethical conduct consistent with industry and organizational standards

The Ideal Candidate

• Bachelor’s degree in Life Sciences or a related field.
• 5–10 years of experience in a GMP-regulated biopharmaceutical environment.
• Experience with biologics - antibody experience being a huge plus.
• In-depth knowledge of GMP regulations (US, EU, ROW), documentation practices, and industry standards (21 CFR, USP, etc.).
• Strong attention to detail and proficiency in analytical thinking and problem-solving.
• Effective written and verbal communication skills.
• Proficiency in Microsoft Office Suite.
• Ability to manage multiple priorities and work independently in a fast-paced setting.

Must have experience:

• CDMO exposure, QA experience in large molecule GMP setting, B.Sc. or above.

Compensation: $110,00 - $150,000

Looking for your next steps in a world leading CDMO? We look forward to your application.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

401(k)

Medical insurance

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