Manager/Senior Manager, Quality Assurance, GCP

Qualification

Bachelor’s degree in a scientific or health field with at least 4 years (Manager level) or 7 years (Senior Manager level) of GxP QA experience, 4+ years GCP QA, supporting both development and commercial programs in the pharmaceutical or biotechnology industry. A minimum of 3 years in a quality lead role in a pharma or biotech environment. Job level commensurate with years of experience. Extensive knowledge of GCP regulations, guidelines, current industry trends, standards, and methodologies. Sound knowledge of GLP regulations, guidelines, current industry trends, standards, and methodologies. Experience interacting with regulatory inspectorates (e.g., FDA, Health Canada, EMA, MHRA) is desirable. Strong understanding of all phases of the drug development process and the interdependencies with other functional areas, but experience in early phase (pre-phase 3) is required. Experience in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks. Ability to effectively prioritize and manage multiple complex projects in parallel and successfully achieve critical milestones and expected deliverables within established timelines and budgets. Must be