Director, Pharmacovigilance Quality Assurance

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. 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, Pharmacovigilance Quality Assurance (PV QA) is responsible for overseeing and ensuring the compliance with Good Pharmacovigilance Practices (GVP) regulations, industry standards and internally established standards and practices for all investigational and marketed products. This is an opportunity to make a significant impact on patient well-being by fostering collaboration and maintaining a high standard of quality. The position lies within the Quality Assurance department and will report directly to the Vice President of Quality Assurance.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

Provide expert, current Good Pharmacovigilance Practices (GVP) quality management consultation to internal stakeholders

Develop, implement and maintain an inspection readiness program

Focus on immediate and short-term (<2 years) strategic planning horizon

Act as the lead Quality representative for pre, during and post inspection activities including direct interactions with inspectors

Ownership of the Crinetics GVP Internal/External Audit Program. Independently oversees and conducts GVP audits considering relevant regulations and industry standards

Conduct risk assessments as appropriate or procedurally required

Proactively escalate quality risks/issues and recommend appropriate solutions to management for immediate and long-term resolution

Compile and deliver quality management system performance metrics and insights to senior management

Lead investigations into PV Quality events, influence appropriate corrective and/or preventative actions and assure follow up and effectiveness of actions

Work cross functionally to establish and/or improve PV internal standards, processes and systems

Perform quality assurance review for PV and Quality related documentation including process modifications, aggregate reports, the PSMF, and more

Write and review Standard Operating Procedures

Prepare and maintain internally and externally-facing quality agreements in collaboration with stakeholders, as well as, review of relevant PV contracts

Facilitate and maintain a risk-based quality system supporting GVP

Embrace the company’s core values and demonstrate adoption through daily work and interactions with others

Participate in the headcount planning process and determine department needs to support ongoing projects/objectives

Lead, direct, manage, coach/mentor, and evaluate direct reports

Other duties as assigned

Education and Experience:

Required:

• A master’s degree in a medical or science-related discipline
• 10 years or more of relevant work experience in PV Quality management with at least 2-5 years of EU GVP implementation experience
• Minimum of 2 years of direct experience in GVP auditing
• Minimum of 8 years in a supervisory/leadership role
• Expert working knowledge and understanding of global regulations for safety and pharmacovigilance including US, EU and ICH guidelines
• Demonstrated leadership presence, strong decision-making capabilities and personal accountability; particularly in a cross-functional team/ project setting
• Ability to build and influence cross-functional stakeholder relationships
• Excellent critical thinking, problem-solving and negotiation skills
• Ability to manage multiple priorities and tasks in a dynamic environment
• Demonstrated ability to effectively organize, and work in a fast-paced environment
• Ability to effectively navigate organizational dynamics
• Strong verbal and written communication skills with ability to present to various audience levels including senior level management
• Software Knowledge: MS Office, e-QMS (e. g. Veeva) systems etc.
• 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 10% - 15% of your time.

The Anticipated Base Salary Range: $166,000 - $207,000

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.