Senior Director, Quality Assurance GMP

Categories: Quality
POSITION SUMMARY:
Crinetics Pharmaceuticals is seeking a highly motivated professional to perform QA GMP functions to support our clinical development programs (Phase 1, 2, 3) and planned future commercial launch, joining its growing and dynamic team.  This job will report to the Head of Quality Assurance.  Crinetics has a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). This individual will be an integral part of the company’s effort to discover, develop and commercialize 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. (Position will be filled at level commensurate with experience).
 
 
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
  • Perform lot release for batches of Drug Substance, Drug Product, Packaging and labeling runs at Contract Research Organizations
  • Compile and maintain lot release database
  • Review and approve testing methodology and specifications for raw materials, intermediates, excipients, APIs and DPs
  • Oversee work at external contract labs/vendors analytical labs, including method development, qualification, transfer, and validation for API and DP
  • Review and approve stability protocols; data and reports for API, DP, intermediates and reference standards
  • Collaborate with CMC and RA in the implementation of product specifications at vendors and for regulatory filings
  • Evaluate, audit, and develop relationships with external parties (CROs, CMOs, RM suppliers)
  • Author, review and implement Standard Operating Procedures,
  • Participate in risk assessment, vendor qualification, inspection activities, and maintain the inspection process for GMP at Crinetics
  • Review and approve documents intended for regulatory filings
  • Review and approve deviations, investigations corrective/preventative actions, change controls, out of specifications and out of trend data to ensure compliance with cGMPs and company standards
  • Review and approve analytical methods, Method Validations, Method Transfers, Material Specifications, Stability Data, Expiry Date Extensions, and Cleaning Validations.,
  • Review and Approve Label Proofs for clinical trial materials in conjunction with the clinical supply manager
  • Review, Implement, and execute CMO Quality Agreements
  • Perform internal audits, as needed
  • Stay current of cGMPs, industry trends, practices, and regulatory guidelines
  • Other duties as assigned
 
 
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
  • BA/BS in Biology or related Science preferred, or equivalent experience
  • A minimum of 15 years of experience in Pharmaceutical and/or Biotech related fields, knowledge of cGMP; Candidate must have strong background in Drug Substance and/or Drug Product Manufacturing (an equivalent combination of experience and education may be considered)
  • 10 years of supervisory/management experience
  • Experience with small molecules and solid oral dose development is a plus
  • Experience with large stakeholder management, QMR, and reporting out to senior management teams
  • You have excellent presentation skills and are familiar with presenting to authorities and to stakeholders at all levels and functions of the company
  • Strong organizational and interpersonal skills, with a keen attention to detail.
  • Must be able to communicate efficiently with Contract Manufacturing Organizations and with internal cross-functional teams
  • Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment
  • Ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner
  • Must possess excellent communication skills, both verbal and written. and ability to write concise SOP’s
  • Strong self-motivation as well as the ability to work independently, and in a team environment with minimum supervision
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  • Ability to identify situations that will require management intervention for resolution
 
 
TECHNICAL KNOWLEDGE REQUIRED:
Equipment:   PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
 
Software Knowledge:  Must possess proficient knowledge of Microsoft Word, Excel, Access and other systems such as Smartsheet, SharePoint, etc.
 
 
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities:  On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking may be required.  The noise level in the work environment is usually low to moderate.  The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable:  Biology and chemical laboratory environments experience needed.  Environmental health and safety requirements also apply.
 
 
TRAVEL:
Travel may be required up to 25% of your time
 
 
The Anticipated Base Salary Range: $180,000.00 – $239,000.00
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown in December.
 
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
 
 
ABOUT CRINETICS:
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and endocrine-related cancer therapeutics company.  Crinetics’ benefit package includes health insurance, stock options, 401k, ESPP, paid time off, and the company provides a dog-friendly work environment.