QA Manager (GCP)

Metric Bio; Town of Texas (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing sector is seeking a Quality Assurance Manager to enhance their Quality Management System. This role involves ensuring compliance with regulatory standards and collaborating across departments to maintain quality throughout clinical trials. Ideal candidates will have a strong background in Quality Assurance within clinical settings and a Bachelor's degree in life sciences or related fields.

Qualifications

• Minimum 3 years of experience in Quality Assurance within a clinical research setting.
• Strong working knowledge of Good Clinical Practice and global regulatory requirements.

Responsibilities

• Lead and support the development of the Quality Management System.
• Oversee QA activities related to clinical trials, including audits and inspection readiness.
• Drive continuous improvement initiatives within clinical QA processes.

Skills

Quality Assurance

Good Clinical Practice

Regulatory Compliance

Education

Bachelor's degree in life sciences

Advanced degree

Job description

5 days ago Be among the first 25 applicants

Direct message the job poster from Metric Bio

BD Executive | Technical/Lab Operations (CLIA/CAP) | Metric Bio

We partnered up with a fast-growing clinical site in seeking a Quality Assurance (QA) Manager to join their team. This role offers the opportunity to be part of a highly innovative environment focused on advancing therapies in oncology and rare diseases through cutting-edge science and technology.

Responsibilities:

• Lead and support the development, implementation, and maintenance of the Quality Management System (QMS) in alignment with regulatory requirements and internal standards.
• Oversee QA activities related to clinical trials, including audits, CAPAs, and inspection readiness.
• Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulations.
• Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and Data Management to ensure quality is embedded across all trial phases (Phase I-IV).
• Participate in vendor qualification and monitoring to ensure adherence to quality standards.
• Conduct internal audits and support external audits/inspections.
• Drive continuous improvement initiatives within clinical QA processes.

Requirements:

• Bachelor's degree in life sciences or related field; advanced degree a plus.
• Minimum 3 years of experience in Quality Assurance within a clinical research setting.
• Strong working knowledge of Good Clinical Practice (GCP) and global regulatory requirements.
• Understanding of drug development phases I-IV and associated quality considerations.
• Experience with clinical trial auditing and vendor oversight.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Pharmaceutical Manufacturing

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