G1 Therapeutics
  • Durham, NC, USA
  • Full Time

Primary Job Responsibilities:

  • Author, establish and review quality policies, procedures and systems to ensure compliance with applicable GMP global health authority regulations, guidance, and corporate policies.
  • Keep abreast of all pertinent GMP regulations and guidance.
  • Provide guidance, interpretation and information pertaining to GMP regulations and guidance to internal staff and contract manufacturing service providers.
  • Contribute to the overall GxP audit program by planning and overseeing the GMP audit function. Ensure all internal and external GMP-related audit findings are addressed with appropriate corrective actions and closed.
  • Approve specifications, sampling instructions, test methods, etc. and other procedures related to CMC/manufacturing operations and other GMP activities.
  • Assist staff to identify root cause of non-compliance/non-conformities and assist staff in developing corrective actions.
  • Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs).
  • Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product.
  • Implement deviation management, CAPA management, and change management processes and systems as pertaining to CMC/manufacturing activities.
  • Ensure readiness of the company for GMP-related inspections by health authorities.
  • Provide quality/compliance review and comment on external service provider quality agreements and contracts.
  • Provide QA review and approval for GMP release.
  • Assist the business in reviewing, selecting, and qualifying external GMP service providers.
  • Additional duties as assigned.

Job and Level Requirements:

  • Bachelor's degree in a life science or relevant discipline required. Graduate degree preferred.
  • 10+ years of experience in Quality / Compliance management or equivalent role in the pharmaceutical industry.
  • Experience with quality/compliance oversight of pre-clinical through product commercialization.
  • Possess in-depth knowledge of FDA and international GMP regulations, guidance, principles, concepts, and industry best practices.
  • Knowledge of 21 CFR Part 11, Annex 11, and PIC/S.
  • Prior experience preparing for, and managing, regulatory agency GMP inspections.
  • Excellent interpersonal and communications skills, including verbal, written, and presentation.
  • Proven planning/organization skills, ability to manage multiple projects simultaneously and the ability to meet tight timescales/deadlines.
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
  • Experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product-related investigations and deviations.
  • Experience working with CMOs and contract testing organizations.
  • Experience conducting internal GMP audits and GMP audits of external service providers.
  • 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.

Full Job Description
G1 Therapeutics
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