Quality Assurance Manager - Government Operations

Emmes Group•Rockville, MD
•Remote

About The Position

The Manager Quality Assurance oversees aspects of Emmes’ Quality Management System and manages staff within the QA Department. The role works with QA, company, and project leadership to ensure adherence to applicable regulations, industry standards, and project requirements. The position is remote in the United States, with the posting specifying Northern Virginia, Maryland, and DC.

Requirements

  • Bachelor’s degree in Life Sciences or a related scientific field.
  • 7–9 years of experience working in a regulated environment, such as GXP or ISO.
  • Management experience.
  • Ability to prioritize critical tasks, provide responsive and timely service day to day, and balance unexpected company needs.
  • Experience interacting with people at all organizational levels using negotiation and influence skills.
  • Demonstrated organizational skills, high attention to detail, and ability to multitask.
  • Strong written and verbal communication and problem-solving skills.
  • Microsoft Office proficiency.

Nice To Haves

  • Quality certifications, such as CQA, RAC, RQAP, or Six Sigma.

Responsibilities

  • Manage a component of Emmes’ Quality Management System, such as the internal auditing program, document control, or CAPA program.
  • May supervise QA Department staff.
  • Review and approve audit reports.
  • Create the internal audit schedule.
  • Lead client audits and regulatory inspections.
  • Conduct audits, including internal and vendor audits, as needed.
  • Draft QA policies and procedures.
  • Contribute to organizational process improvement.
  • Prepare Quality Management reports for QA management and internal leaders.
  • Review and approve corporate SOPs as needed.
  • Provide corporate training as needed.
  • Communicate quality or compliance issues to QA and organization management.
  • Perform other duties as assigned.
  • Comply with all policies and standards.

Benefits

  • Flexible Approved Time Off
  • Tuition Reimbursement
  • 401k Retirement Plan
  • Work From Home Anywhere in the US
  • Maternal/Paternal Leave
  • Casual Dress Code & Work Environment
  • Opportunities for volunteerism through the Emmes Cares community engagement program
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