Crinetics Pharmaceuticals

Crinetics Pharmaceuticals

Director, Quality Engineering

Remote, USA · Director

Sponsorship not specified$190k-$223kDetected 91 days ago
Product ManagementSupply ChainProcess ImprovementGMPFDA RegulatoryAnimal StudiesLeadershipCommunicationMentoringRegulatory Affairs

About the role

  • This key leadership role is responsible for embedding a proactive, risk-based mindset across global operations to ensure product quality, patient safety, and sustained regulatory compliance.
  • include strengthening inspection readiness, reinforcing data integrity, and driving a robust Corrective and Preventive Action (CAPA) culture across the organization.
  • A strong emphasis will be placed on global GMP alignment, system effectiveness (e.g., change control, deviation management, batch disposition), and cultivating a culture of accountability, transparency, and continuous learning.

Responsibilities

  • The role will also lead initiatives to optimize quality systems and deliver measurable performance improvements across the value chain.
  • This is a high-impact role offering the opportunity to shape the company's global quality strategy and build a culture of quality excellence - ultimately improving operational performance and advancing patient outcomes worldwide.
  • Lead the development and execution of global GMP quality engineering strategies aligned with regulatory expectations and business objectives.
  • Serve as the organizational lead for Quality Risk Management (QRM), establishing risk-based approaches to identify, evaluate, and mitigate quality and compliance risks.
  • Drive continuous improvement (CI) initiatives using tools such as Lean, Six Sigma and root cause analysis to improve product quality, process robustness, and operational efficiency.
  • Strengthen data integrity controls and drive global initiatives to ensure compliance with ALCOA+ principles.
  • Lead quality oversight for manufacturing activities, tech transfer, scale-up, validation, and commercial production to ensure end-to-end GMP compliance.
  • Collaborate cross-functionally with Manufacturing, QC, Regulatory Affairs, Supply Chain, and Commercial teams to embed quality into operational decision-making and strategic planning.
  • Develop and implement risk-based monitoring and metrics to proactively assess performance and compliance trends.
  • Lead and mentor a global team of quality engineers and specialists; build capabilities through training, coaching, and talent development.

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 15% of your time.

Nice to have

  • Deep technical expertise in GMP-compliant manufacturing environments
  • Thorough understanding of evolving global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA)
  • Candidate must have strong background in Drug Substance and/or Drug Product Manufacturing, experience with small molecules and solid oral dose development is a plus
  • 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

Compensation

  • The salary range for this position is: $190000 - $223000.
  • In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.

Benefits

  • Represent the Quality function in strategic business forums and quality governance meetings; act as a key quality liaison to executive leadership and health authorities.

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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