Job Description

• Need to sit onsite in Everett, WA (relocation assistance available)

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. Their goal will be to integrate internal and external quality info inputs to quickly adapt and modulate QA activities. The QA Manager - Lab Sciences will also utilize the application of risk assessment approaches within QA operations. Their goal will be to insure QA operations consistently meet internal and external timelines. They will be expected to be the second level of quality issue escalation / conflict resolution.

Duties:

• 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.

Qualifications:

• 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.
• Tactful, reliable, persuasive, dependable, consistent, flexible.
• Excellent written and oral communication skills.
• Software: Microsoft Office.

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