Director, Quality Systems, Project Management, QRM, RS

Position Summary 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 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 met. Monitor project risks, issues, and performance metrics; elevate as necessary. 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). Own the GxP Risk Management Program and upgrade to the 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 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 projects as assigned by the Senior Director, Quality Systems. Education and Experience Bachelor’s degree or Master’s degree in a 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 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 involving numerous components. Excellent collaboration, interpersonal, verbal, and written communication skills. Good presentation skills to internal and external audiences. Able to work on issues where analysis of situations or data require conceptual thinking and in‑depth knowledge. Has experience using a risk‑based approach. Physical Demands and Work Environment Continuous desk work, use of a keyboard and telephone. Some walking and lifting up to 25 lbs. Noise level typically low to moderate. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Laboratory Activities (if applicable) Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel Travel up to 5% of time may be required. 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 & Benefits Salary range: $178,000 – $223,000. In addition to base pay, our total rewards program includes: Discretionary annual target bonus Stock options and ESPP 401(k) match Top‑notch health insurance plans (medical, dental, vision, basic life insurance) 20 days of paid time off (PTO) 10 paid holidays Winter company shutdown #J-18808-Ljbffr Crinetics Pharmaceuticals, Inc.