Crinetics Pharmaceuticals

Crinetics Pharmaceuticals

Director, Quality Systems, Project Management, QRM, RS

US California, USA · Director

Sponsorship not specified$178k-$223kDetected 77 days ago
GCPProject ManagementStakeholder ManagementProcess ImprovementGMPFDA RegulatoryPharmacovigilanceAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingPublic SpeakingHACCPGxP

About the role

  • We are seeking a highly skilled Director of Quality Systems with a focus on Project Management, Quality Risk Management (QRM), and Regulatory Surveillance to join our Quality team.
  • This role will be instrumental in managing QA projects, implementing risk management strategies and tools, and ensuring adherence to cGMP regulations and global pharmaceutical quality standards.
  • Essential Job Functions and Responsibilities:

Responsibilities

  • Lead or support QA-related projects, including new system implementations, process optimization, and compliance initiatives.
  • Lead After Action Review exercises to promote continuous improvement.

Requirements

  • Some walking and lifting up to 25 lbs. may be required.
  • 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.
  • You may be required to travel for up to 5% of your time.

Nice to have

  • Bachelor's degree or Master's degree in technical field with a minimum of 12 years of relevant Quality Assurance experience in a biotech/pharmaceutical setting.
  • 8 years of supervisory experience.
  • GMP experience working with CMOs.
  • GCP/GLP experience working with CROs is a plus.
  • Proactive leader of quality and compliance culture.
  • Additional understanding of GCP, GLP, and pharmacovigilance regulations is a plus.
  • In-depth understanding of global pharmaceutical regulations and quality systems.
  • Ability to interpret complex regulatory requirements and apply them pragmatically.

Skills

  • Define project scope, timelines, deliverables, and resource needs.
  • Coordinate cross-functional project teams and ensure milestones are et.
  • Monitor project risks, issues, and performance metrics; escalate as needed.
  • Prepare project status reports and presentations for senior management.
  • Identify, assess, and mitigate quality risks using structured methodologies (e.g., FMEA, HACCP, Risk Matrices).
  • Ownership of GxP Risk Management Program and escalate to enterprise-wide risk management board.
  • Develop and maintain risk management plans and documentation.
  • Facilitate risk review meetings and ensure proactive quality risk communication.
  • Monitor the effectiveness of risk controls and update risk assessments regularly.
  • Monitor global regulatory trends, guidance updates, and enforcement actions from regulatory agencies such as FDA, EMA, MHRA, WHO, and PIC/S.
  • Communicate regulatory updates and risk impact assessments to Quality, Regulatory and other impacted departments.
  • Evaluate impact of emerging regulations on internal quality systems, products, and processes.

Compensation

  • The salary range for this position is: $178,000 - $223,000.
  • In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.

Benefits

  • Environmental health and safety requirements also apply.
  • 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.

Company info

  • Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors.
  • We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives.
  • Our work continues to make a real difference in the lives of patients.
  • We have a prolific discovery engine and a robust preclinical and clinical development pipeline.
  • We are driven by science with a patient-centric and team-oriented culture.
  • Crinetics is known for its inclusive workplace culture.
  • We are also a dog-friendly workplace.
  • This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients.
  • Join our team as we transform the lives of others.

Equal opportunity

  • Employer:
  • Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
  • Crinetics is proud to be an Equal Opportunity Employer.
  • We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Visa & Work Authorization

  • tation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union s
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This listing is sourced directly from Crinetics Pharmaceuticals's careers page and normalized into a canonical job model.