Altasciences · 3 hours ago
Lab Sciences QA Manager- FR
Everett, WA
Full-time
Onsite
Senior Level
$90K/yr - $115K/yr
5+ years expAltasciences is focused on the discovery, development, and manufacturing of new drug therapies. The QA Manager - Lab Sciences will manage QA staff and resources to ensure efficiency across functions and sites, and will be responsible for staff development and aligning with strategic plan needs.
BiotechnologyHealth CareMedical
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
Benefits
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Telework when applicable.
Training & Development Programs
Employee Referral Bonus Program
Company
Altasciences
Outsourcing made easy with a one-stop solution to early-phase drug development.
1001-5000 employees
H1B Sponsorship
Altasciences 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
2024 (1)
2023 (1)
2022 (2)
Funding
Current Stage
Late StageLeadership Team
Beatrice S.
Chief Scientific Officer
Bryce Linna
HR Business Partner
Company data provided by crunchbase