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Associate Director/Director, Quality Assurance at Crinetics Pharmaceuticals
San Diego, CA, US

Crinetics Pharmaceuticals is seeking a highly motivated professional to provide oversight of all GCP, GLP and GLP (GXP) QA functions. This individual will be responsible for creations, maintenance, and continuous improvement of the corporate Quality System Management, in compliance with FDA, European, and other country-specific regulations. The individual will be responsible for developing collaborative and productive partnerships internally, as well as externally with contract research/manufacturing organizations. This individual will be an integral part of the company’s effort to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related tumors. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

Responsibilities

These may include but are not limited to:

  • Create and develop GXP Quality Systems, as needed, to ensure compliance withrelevant regulations, in a development phase-appropriate manner from preclinical toclinical development and commercialization
  • Support investigational new drug applications (IND), ex-US clinical trial applications(CTA), and related correspondence with FDA and other global regulatory authorities
  • Key point person for ensuring a well-defined and structured control of GXPdocumentation (e.g., Development History File)
  • Manage Document Control functions including SOPs and Change Control
  • Participate in cross-functional teams, providing feedback and support
  • Partner with external vendors in support of Quality document generation thatincorporates company-specific needs within the vendor’s established processes
  • Oversee and manage GXP QA auditing and vendor management, including all internaland external audits of GXP service providers
  • Manage investigations, regulatory agency inspection preparation activities, and otherQA activities (i.e. training)
  • Verify that appropriate corrective actions are taken as a result of audit observationsand investigations, when necessary, and ensure timely closure of GXP audit activities
  • Maintain up-to-date knowledge of the GXP quality landscape, regulations, andguidelines
  • Responsibility for identifying GXP risks and mitigation plans
  • Identify and oversee consultants that perform specific GXP QA work for the company
  • Other tasks as assigned

Minimum Qualifications

  • Bachelor’s degree required. Advanced scientific degree strongly preferred. (Anequivalent combination of experience and education may be considered.)
  • Minimum of 8-10 of relevant GXP experience in a biotech/pharmaceutical setting
  • Detailed understanding of US and international regulations and guidance documents
  • Strong experience in IND and CTA filings; NDA/BLA/MAA experience stronglypreferred
  • Experience in auditing CMO and CRO vendors; ability to travel domestically andinternationally as required
  • Experience in hosting and managing Health Authority GXP inspections
  • Experience managing other full-time employees and/or contractors
  • Ability to remain objective/autonomous in overseeing the Quality Program, while atthe same time taking ownership and proactively working with functionaldepartments to achieve the desired quality objectives
  • Strong project management skills with ability to manage multiple projects andexecute in adherence to timelines
  • Desire to work in a collaborative team setting
  • Excellent interpersonal, verbal, and written communication skills
  • Ability to write clearly at a level appropriate to the audience and the project withcareful attention to detail and accuracy
  • Ability to work and prioritize several projects at once while balancing multiple andoverlapping timelines
  • Ability to assess workload and suggest prioritization to senior staff

Travel

Travel may be required up to 20% of your time