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QA Director, GLP Preclinical

New Jersey, USA ● Pennsylvania, USA ● Scranton, PA, USA Req #3622
Friday, March 17, 2023

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 Director is responsible for managing the overall QA functions of a GLP Preclinical site. They will represent and assist the Vice President GLP Quality Assurance in corporate-wide projects and establish priorities and timelines at the site management level for requests pertaining to the site QA team. They are responsible for site and functions to ensure internal procedures, ongoing work and released study reports meet all acceptable regulatory obligations. They are responsible for the development of the site QA staff. They provide corporate quality intelligence by monitoring major regulatory updates / industry trends and identifies and leads opportunities or change management needs.

What You'll Do Here

  • Provides oversight and performance management of the QA staff;
  • Work with managers, site QA staff to maintain and improve all elements of quality systems and compliance
  • Collect & monitor quality metrics and provide regular quality status updates, ongoing signals and actions taken.
  • Provide QA educational leadership and coach, develop, and serve as a resource to direct reports for their career path.
  • Monitor the performance of direct reports towards their annual goals.
  • Work with QA staff to ensure there is adequate & effective QA coverage of trial activities;
  • Assist TFM and/or conduct investigations to support root cause analysis of critical and major deviations/incidents, and coordinate with QMS management and site operational leadership to ensure appropriate corrective and preventative actions are taken;
  • Ensure Altasciences Preclinical site Operations are in compliance with company SOPs and applicable regulations.
  • Facilitate quality and compliance review meetings, track and trend the state of quality, Assist TFM in CAPAs and other continued improvement opportunities for the sites.
  • Lead quality initiatives identified through the QMS, sponsor and/or regulatory inspection audits;
  • Other duties as assigned.

What You'll Need to Succeed

  • Bachelor's Degree or higher
  • Previous experience in a similar role
  • Previous experience in Quality Assurance
  • Strong analytical and problem solving skills
  • Thorough knowledge of applicable regulatory requirements
  • Detailed oriented and organized
  • Ability to meet tight timelines
  • Excellent communication and interpersonal skills
  • Good computer skills and ability to learn new technology as needed
  • Expertise knowledge of GLP is required
  • Exceptional leadership skills, quality assurance knowledge and managing personally abilities

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' BenefitsPackage 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 
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!

Other details

  • Pay Type Salary
Location on Google Maps
  • New Jersey, USA
  • Pennsylvania, USA
  • Scranton, PA, USA