Planet Pharma · 1 day ago
Quality Assurance Manager (Relo Available)
Everett, WA
Full-time
Onsite
Senior Level
5+ years expPlanet Pharma is seeking a Quality Assurance Manager for Lab Sciences to oversee QA staff and resources to ensure operational efficiency. The role involves managing QA activities, integrating quality inputs, and ensuring compliance with internal and external standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Qualification
Required
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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase