G1 Therapeutics
  • Durham, NC, USA
  • Full Time

Primary Job Responsibilities:

  • Quality Control (QC) technical, scientific and compliance review of data and documents generated by Development Operations and Research & Development organizations.
  • Study protocols
  • Investigator's Brochures
  • Clinical/scientific publications
  • Regulatory filings
  • Policies and procedures
  • Issue QC review reports and work closely with staff to ensure compliance with appropriate regulations and guidance.
  • Verify accuracy of data and information contained in internal and external documents
  • Develop, coordinate and conduct QC training within department and for other departments
  • Assist in trending regulatory submission document QC activities
  • Assist in periodic reconciliation of Master Audit Plan against actual audits performed
  • Assist in educating, guiding and influencing staff with regard to best practices in GxP compliance.
  • Additional duties as assigned.

Job and Level Requirements:

  • Bachelor's degree required in a life science or relevant discipline.
  • 3 years of experience in Quality / Compliance or equivalent role in the pharmaceutical industry.
  • 1+ year of direct experience with document QC review.
  • Possess in-depth knowledge of FDA and international GxP regulations, guidance, principles, concepts, and industry best practices.
  • Excellent interpersonal and communications skills, including verbal, written, and presentation.
  • Proven ability to coordinate multiple projects simultaneously and the ability to meet tight timescales/deadlines.
  • Exceptional attention to detail.
  • Ability to work collaboratively in a cross-functional team environment.
  • Experience working with oncology products preferred.

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

G1 Therapeutics
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