Lab Sciences QA Manager; Relo

Job Summary

The QA Manager – Lab Sciences will be responsible for managing QA staff and resources to ensure efficiency across functions and sites in support of Lab Sciences operations. They will also be responsible for staff development and align with strategic plan needs. The goal is to integrate internal and external quality information to quickly adapt and modulate QA activities. The role utilizes risk assessment approaches within QA operations to ensure consistent timeliness and acts as the second level of quality issue escalation and conflict resolution.

Location:
Everett, WA (relocation assistance available)

• Maintain and monitor Key Performance Index related to QA pertinence and timelines.
• Manage the internal inspection program and ensure its completion on an annual basis.
• Identify and coordinate training within the group.
• Approval of audit plans to ensure they’re adequate and reflective of the needs identified from risk assessment strategies and various quality input information.
• Participate in the coordination and logistics of sponsors and/or regulatory authorities inspections.
• Prepare annual staff development plans, provide resources towards their completion, and perform adequate follow-ups through regular 1:1 staff meetings.
• Integrate quality inputs to modulate QA activities strategies and focus.
• Provide quarterly quality reports to the director on initiatives, risk assessment approaches, and results.
• Participate in the review of regulatory agency and/or sponsor’s deficiency letter to ensure they’re adequate, complete, compliant, and with the required courtesy and tact.
• Lead identified quality initiatives/projects identified through QMS, sponsor audits, and/or regulatory inspection audits.

• Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field with a minimum of five years experience, or equivalent combination of education and experience, in the pharmaceutical industry.
• Extensive knowledge of GLP and clinical sample analysis experience.
• Knowledge and understanding of the applicable US, Canadian, European, and ICH pharmaceutical regulations and guidelines.
• Detail oriented and ability to meet tight deadlines.
• Project management and coordination skills.
• Excellent written and oral communication skills.
• Software:
  Microsoft Office.

Mid‑Senior level

Full‑time

Science

Research Services

• Vision insurance
• Medical insurance