Associate Director, Quality Systems

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 Associate Director, Quality Systems will be responsible for creation, maintenance, and continuous improvement of the corporate Quality System, in compliance with FDA, European, and other country-specific regulations. In this role, the individual will additionally provide support to our GxP team members by providing training, project management support, and computer system validation oversight. 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:

• Directly support the Senior Director, Quality Systems with management of Quality Systems procedures and computer systems (eg, Veeva QualityDocs, LMS, QMS, and other modules).
• Maintain and improve the Quality Management System and provide an on-going assessment of Quality Management System health and effectiveness.
• Collaborate with cross-functional teams to ensure alignment on quality objectives and priorities.
• Enhance quality metrics, key performance indicators, and dashboards to monitor the QMS performance, drive continuous improvement, and report to QMR.
• Create and review policies, procedures, work instructions and other supporting documentation.
• Key point person for ensuring a well-defined and structured control of GxP documentation (e.g., Development History File) and driving document mapping project across impacted GxP teams.
• Identify and drive enhancements within eDMS and QMS with input from continuous improvement and document mapping processes.
• Ensure compliant use of QMS electronic system in collaboration with GxP Quality Leads
• Serve as Project Manager for various QA projects and initiatives.
• Develop and deliver various GXP training, including Inspection Readiness training.
• Lead or participate in GxP QA auditing and vendor qualification of key Quality Systems vendors
• Maintain up-to-date knowledge of the GxP quality landscape, and monitor periodic updates to regulations, and guidelines. Proactively implement necessary updates to QMS.
• Identify GxP risks and mitigation plans.
• Oversee QA Computer Systems Validation process.
• 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.
  
  

Required

Education and Experience:

• Bachelor’s degree or Master’s degree in technical field with a minimum of 10 years of relevant Quality Assurance GxP experience in a biotech/pharmaceutical setting. An equivalent combination of experience and education may be considered.
• 7 years of experience in a supervisory role.
• GMP experience working with CMOs. GCP/GLP experience working with CROs is a plus.
• Proactive leader of quality and compliance culture.
• Experience with the use, change control and testing of Veeva QualityDocs and QMS.
• 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.
• Experience in auditing CMO and CRO vendors.
• Understanding and experience with computer system validation, change control and 21 CFR Part 11, Annex 11, and GAMP 5.
• Ability to travel domestically and internationally as required.
• Ability to remain objective/autonomous in overseeing the Quality Program, while at the same time taking ownership and proactively working with functional departments to achieve the desired quality objectives.
• 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.
• Outstanding organizational, prioritization skills, with attention to detail.
• 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.

The Anticipated Base Salary Range: $135,000 -$180,000

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.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

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.

Vaccination Requirement

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.