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QA Manager - Cypress, United States - Altasciences
Description
Your New CompanyAt Altasciences we all
move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.
No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe.
By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.
We are better together and together We Are Altasciences.About The Role
The QA manager is responsible for managing QA staff and resources in support of clinical trial-related activities and ensure efficiency across functions and sites, staff development, and aligning with strategic plan needs.
Additional responsibilities include integrating internal and external quality information inputs to quickly adapt and modulate QA activities as well as the application of risk assessment approaches within QA operations.
This position will ensure QA operations consistently meet internal and external timelines and provides a second level of quality issue escalation.
What You'll Do HereMaintain and monitor Key Performance Index related to QA
pertinence and timelines.
Manage the internal inspection program, and ensure itscompletion on an annual basis.
Identify and coordinate training within the group.
Approval of audit plans, to ensure they're adequate andreflective of the needs identify from risk assessment strategies,and various quality input information.
Participate into the coordination and logistics of sponsors and/orregulatory authorities inspections.Prepare annual staff development plans, and provide resources
towards their completion, and perform adequate follow-ups
through regular 1:1 staff meetings.
Integrate quality inputs from QA leadership to modulate QA activities, strategies an 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'sdeficiency letter to ensure they're adequate, complete, compliant,and with the required courtesy and tact.
Lead identified quality initiatives/project identified throughQMS, sponsor audits, and/or regulatory inspection audits.What You'll Need To Succeed
Bachelor degree or higher, in Chemistry, Biochemistry, Biology,or equivalent field with a minimum of five years experience, orequivalent combination of education and experience, in thepharmaceutical industry.
Knowledge and understanding of the applicable Canadian, US,European, and ICH pharmaceuticalregulations and guidelines, for phase I research studies (i.e., GCP,GLP, and GMP).
Detail oriented, project management and coordination skills.
Ability to meet tight deadlines, tactful, reliable, persuasive, dependable, consistent, flexible.
Good written and oral communication skills inEnglish
What We Offer
The pay range estimated for this position is $78,000 - $120,000.
Please note that salary rates vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data .
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences' Benefits Package Includes:
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Training & Development Programs
Employee Referral Bonus Program
Annual Performance Reviews
#LI-AN1
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
Altasciences is an equal opportunity employer committed to diversity and inclusion.
Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.
Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences#J-18808-Ljbffr
