COMPANY OVERVIEW:
Agios Pharmaceuticals is focused on discovering and developing novel drugs to treat cancer and rare genetic metabolic diseases, through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutics areas, Agios has multiple first-in-class lead product candidates in cancer metabolism and rare genetic metabolic diseases in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics.
POSITION OVERVIEW:
We are currently seeking a Sr. Manager or Associate Director, Quality Systems. This position will support the organization by establishing and continuously improving Quality Management Systems (QMS) aligned with industry standards and in accordance with the relevant product’s lifecycle.
RESPONSIBILITIES:
- Develop the QMS to support early-stage clinical, late-stage clinical and future commercial operations.
- Supporting internal quality systems, vendor management, audits and inspections, change control, deviations, investigations, corrective/preventative actions, risk assessments, computer systems validation and other GXP systems
- Provide oversight for the GXP document control and training functions
- Facilitate quality system improvement activities
- Working with appropriate functional areas to ensure that the quality systems are effectively implemented and maintained in compliance with relevant standards and regulations.
- Understanding global regulatory agency policies and guidance as they pertain to Quality issues including 21 CFR Part 11 compliance
- Evaluate and implementing electronic systems to support management of quality systems
- Conduct/support internal and external audits as appropriate
- Business owner of enterprise electronic document management systems (eDMS)
REQUIREMENTS:
- BA or BS degree (preferably a scientific discipline) plus at least 7+ years of pharmaceutical experience in Quality Management Systems
- Demonstrated expertise and hands-on experience with quality systems regulations and guidelines including working in a cGMP environment. GLP and GCP experience a plus
- Experience providing leadership and oversight of implementation of 21 CFR Part 11 compliant Quality Management Systems
- Experience in the implementation and management of 21 CFR Part 11 compliant applications as business owner and super user
- Exercises judgment within broadly defined practices and policies in determining solutions and actions
- Ability to develop clear, concise, and timely oral and written reports
- Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information
Demonstrated project management