Director, Quality Systems, Project Management, QRM, RS

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:

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. The ideal candidate brings cross-functional leadership, regulatory knowledge, and strong analytical capabilities to support our commitment to patient safety and product integrity. This role is also responsible for developing collaborative and productive partnerships internally, as well as externally with Global sites and strategic partners. 

Essential Job Functions and Responsibilities:
These may include but are not limited to:

• Lead or support QA-related projects, including new system implementations, process optimization, and compliance initiatives.
• 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.
• Lead After Action Review exercises to promote continuous improvement.
• 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.
• Support timely revision of SOPs, training, and processes in response to regulatory changes or inspection observations.
• Identify compliance gaps and improvement opportunities to inform the corporate Quality Plan and/or Inspection Readiness plans.
• Support inspection-readiness activities and regulatory inspections. 
• Manage and mentor the individuals in the quality systems and compliance teams to continually develop and enhance skills.
• Foster a Quality culture that values innovation, continuous improvement, and personal accountability
• Execute other duties and project, as assigned by the Senior Director, Quality Systems. 
• Other duties as assigned

Education and Experience:
Required:

• 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. An equivalent combination of experience and education may be considered.
• 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.
• Expert working knowledge and understanding of US and international GMP regulations and guidance documents. 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.
• Strong Quality Risk Management background and understanding of QRM principles and tools.
• Strong analytical, organizational, and stakeholder communication skills.
• Skilled in using QMS and project management tools (e.g., Veeva, MS Project).
• Strategic mindset with attention to detail and a continuous improvement orientation.
• Strong project management skills with ability to manage multiple projects and execute in adherence to timelines.
• Demonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous components
• Excellent collaboration, interpersonal, verbal, and written communication skills. 
• Good presentation skills to both internal and external audiences. 
• Able to work on issues where analysis of situations or data require conceptional thinking and in-depth knowledge.
• Has knowledge and experience using a risk-based approach.

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.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:
You may be required to travel for up to 5% 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.