Director, Quality Engineering

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.

POSITION SUMMARY:

The Director of Quality Engineering will lead the development, integration, and execution of strategic GMP quality initiatives within a fast-paced, highly regulated pharmaceutical environment. 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.

As the enterprise lead for Quality Risk Management (QRM) and Continuous Improvement (CI), the Director will oversee the design and implementation of scalable, risk-based quality frameworks that anticipate and mitigate compliance and supply chain risks. Responsibilities include strengthening inspection readiness, reinforcing data integrity, and driving a robust Corrective and Preventive Action (CAPA) culture across the organization. The role will also lead initiatives to optimize quality systems and deliver measurable performance improvements across the value chain. Working cross-functionally with Manufacturing, Quality Control, Regulatory Affairs, Commercial, and Supply Chain teams, the Director will ensure GMP compliance throughout the product lifecycle - from technology transfer and scale-up to commercial manufacturing and distribution. 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.

The ideal candidate will have deep technical expertise in GMP-compliant manufacturing environments, a thorough understanding of evolving global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA), and a proven track record of leading quality transformation initiatives that deliver both regulatory confidence and operational excellence. 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.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

• 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.
• Oversee the enhancement and maintenance of core quality systems (e.g., CAPA, deviation management, change control, batch release, investigations) to ensure effectiveness and inspection readiness.
• 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.
• Provide strategic direction during regulatory inspections (FDA, EMA, MHRA, PMDA) and internal audits; ensure timely resolution of observations and sustainable remediation.
• 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.
• Guide quality input for new product introductions (NPI), clinical and commercial launches, and global supply chain strategies to ensure product availability and regulatory alignment.
• Lead and mentor a global team of quality engineers and specialists; build capabilities through training, coaching, and talent development.
• Represent the Quality function in strategic business forums and quality governance meetings; act as a key quality liaison to executive leadership and health authorities.
• Foster a culture of quality excellence, ownership, and continuous learning throughout the organization.
• Other duties as assigned

Education and Experience:

Required:

• Bachelor’s degree in a science discipline and at least 12 years of experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) with a minimum of 8 years supervisory/leadership experience
• Deep technical expertise in GMP-compliant manufacturing environments
• Thorough understanding of evolving global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA)
• Experience leading quality transformation initiatives that deliver both regulatory confidence and operational excellence
• 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
• 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 

Preferred:

• Solid dosage or small molecule experience is preferred, however, experience in other dosage forms with relevant experience is acceptable.
• Prior experience with Veeva QMS systems (Quality vault)

Physical Demands and Work Environment:

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 and lifting up to 25 lbs. may be required. The noise level in the work environment is typically 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.

Travel:

You may be required to travel for up to 15% of your time.

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.

Salary Range

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.