Job 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 Quality Assurance Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality.

What You'll Do Here:

• Manages QA staff and resources to ensure efficiency across functions and sites.
• Responsible for staff development and align with strategic plan needs.
• Integrate internal and external quality information to quickly adapt and modulate QA activities.
• Application of risk assessment approaches within QA operations.
• Lead the coordination and logistics of sponsors and/or regulatory authorities inspections.
• Ensure QA operations consistently meet internal and external timelines.
• Second level of quality issue escalation / conflict resolution.
• Maintain and monitor Key Performance Index related to QA pertinence and timelines.
• Approve the annual internal audit program and ensure they are adequate and reflective of the needs identify from risk.
• Identify and coordinate training within the group.
• Author responses to regulatory agency and/or sponsor’s audit findings to ensure they are adequate, complete, compliant, and appropriate.
• Prepare annual staff development plans, and provide resources towards their completion.
• Integrate quality inputs from the other departmental managers
• Provide quarterly quality reports to senior management, on initiatives, risk assessment approaches and results.

What You'll Need to Succeed:
Education:

• Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field with a minimum of ten years experience, or equivalent combination of education and experience, in the pharmaceutical industry.

Skills:

• Strong knowledge and understanding of US, Canadian and EU GMP Regulations and guidelines.
• Detail oriented.
• Project management and coordination skills.
• Ability to meet tight deadlines.
• Tactful, reliable, persuasive, dependable, consistent, flexible.
• Good written and oral communication skills
• Skills in software applications including Microsoft Office, QMS, and inventory management systems.

What We Offer:
Benefits (regular employees)

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
• Telework when applicable

Altasciences' Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program

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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!

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