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Clinical QA Manager / Sr. Clinical QA Manager

Clinical QA Manager / Sr. Clinical QA Manager

ActalentBethesda, MD, US
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Deputy Clinical QA Manager

We are seeking a Deputy Clinical QA Manager to join our team. The successful candidate will manage a team of clinical QA personnel while conducting both internal and external audits within GCP guidelines. This role will serve as the right hand to the VP, ensuring the highest standards of quality and compliance.

Responsibilities

  • Conduct clinical site audits, both domestically and internationally, to verify regulatory and protocol compliance.
  • Ensure clinical compliance with applicable Standard Operating Procedures (SOPs) and regulations.
  • Review clinical audit reports and provide guidance to auditors.
  • Support the inspection readiness program and serve as a subject matter expert for quality.
  • Promote quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System.
  • Host client audits, conduct external audits at clinical and vendor sites, and lead process improvement activities and CAPA investigations.
  • Support regulatory authority inspections.

Essential Skills

  • Minimum of 5 years of solid understanding and working knowledge of GCP, with a possible consideration for 3+ years with strong supporting experience.
  • Experience working with eQMS.
  • Proficiency in MS Office.
  • Experience supervising staff.
  • Additional Skills & Qualifications

  • Certified Quality Auditor (CQA) preferred.
  • Advanced degree preferred.
  • Ability to travel 10-20% both domestically and internationally.
  • Work Environment

    The position offers a flexible work environment with 2 days on-site and 3 days working from home. Alternatively, fully remote work is available for candidates residing in North Carolina, Virginia, Washington D.C., or Maryland. The role involves international travel with 1 domestic trip every other month and 2+ international trips per year.

    Job Type & Location

    This is a Contract to Hire position based out of Bethesda, Maryland.

    Pay and Benefits

    The pay range for this position is $52.88 - $62.50 / hr.

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

    Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off / Leave (PTO, Vacation or Sick Leave)

    Workplace Type

    This is a fully remote position.

    Application Deadline

    This position is anticipated to close on Oct 22, 2025.

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    Qa Manager • Bethesda, MD, US

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