QA Manager
Apply NowCompany: Altasciences
Location: Sacramento, CA 95823
Description:
Your New Company!
At 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 will be responsible for managing QA staff and resources to ensure efficiency across functions and sites. 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 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.
What You'll Do Here
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 identify from risk assessment strategies, and various quality input information.
Participate into the coordination and logistics of sponsors and/or regulatory 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 the QA Systems Manager, and QA Compliance Manager 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/project identified through QMS, 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, or equivalent combination of education and experience, in the pharmaceutical industry.
Knowledge and understanding of the applicable Canadian, US, European, and ICH pharmaceutical
regulations 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 in French and English
Software: Microsoft Office.
What We Offer
The pay range estimated for this position is $84,571 to $118,000 per year. Please note that hourly rates/salaries 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
Altasciences' Incentive Programs Include
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!
At 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 will be responsible for managing QA staff and resources to ensure efficiency across functions and sites. 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 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.
What You'll Do Here
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 identify from risk assessment strategies, and various quality input information.
Participate into the coordination and logistics of sponsors and/or regulatory 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 the QA Systems Manager, and QA Compliance Manager 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/project identified through QMS, 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, or equivalent combination of education and experience, in the pharmaceutical industry.
Knowledge and understanding of the applicable Canadian, US, European, and ICH pharmaceutical
regulations 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 in French and English
Software: Microsoft Office.
What We Offer
The pay range estimated for this position is $84,571 to $118,000 per year. Please note that hourly rates/salaries 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
- Employee Assistance & Telehealth Programs
Altasciences' Incentive Programs Include
- Training & Development Programs
- Employee Referral Bonus Program
- #LI-BK1
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!