Remote Quality Assurance Manager - Life Sciences & Audits

Emmes

Rockville (MD)

Remote

USD 120,000 - 170,000

Full time

7 days ago
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Job summary

Emmes Group is seeking a Quality Assurance Manager to oversee elements of the QA program in a government-focused clinical research environment. The role may supervise QA staff and drive audits, CAPA, and documentation control to ensure compliance with GXP/ISO standards.

The ideal candidate will hold a Life Sciences degree, possess relevant quality certifications, and bring 7–9 years of regulated experience along with strong communication and leadership skills to support internal and external

Qualifications

  • Bachelor's degree in Life Sciences or related field required.
  • Quality Certifications e.g., CQA, RAC, RQAP, Six Sigma preferred.
  • 7-9 years in a regulated environment (GXP/ISO) required.
  • Management experience required.
  • Strong communication and organizational skills supported by attention to detail.

Responsibilities

  • Oversee components of the QA program within Emmes' QA Department.
  • May supervise QA staff and review audit reports.
  • Lead internal and client audits and regulatory inspections.
  • Draft and maintain QA policies and SOPs.
  • Prepare QA management reports for leadership.

Skills

Leadership
Regulated env.
Quality Assurance

Education

Bachelor's Degree Life Sciences

Tools

Microsoft Office

Job description

Emmes Group is seeking a Quality Assurance Manager to oversee elements of the QA program in a government-focused clinical research environment. The role may supervise QA staff and drive audits, CAPA, and documentation control to ensure compliance with GXP/ISO standards.

The ideal candidate will hold a Life Sciences degree, possess relevant quality certifications, and bring 7–9 years of regulated experience along with strong communication and leadership skills to support internal and external

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