Senior Director, Quality Assurance, EU

Crinetics is a pharmaceutical company headquartered in San Diego, California, USA with offices in Zug, Switzerland and expanding our presence in Europe. We develop 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:

As the Senior Director, Quality Assurance (EU, Netherlands-based) or (optionally) Qualified Person, you will be an important part of Crinetics' global GMP QA team to ensure compliance to industry GMP and GDP standards and regulations. This position will be located in the Netherlands (Amsterdam), reporting to the Executive Director, Quality Assurance GMP & GDP (located in the US) and dotted line reporting to the Senior Vice President, EU General Manager (SVP EU GM, located in Switzerland).

This position is to fulfill the technical responsibilities of an EU Quality Assurance professional and/or (optionally) Qualified Person with oversight of the Swiss Responsible Person (RP, Fachtechnisch verantwortliche Person (FvP)) in relation with the Swiss Establishment License in compliance with Swiss Law SR 812.212.1, Medicinal Products Licensing Ordinance (MPLO) in Switzerland. The Swiss RP, under Crinetics Quality Assurance oversight, must be able to execute his/her responsibility, understand the Swiss GMP/GDP requirements and meet regulatory compliance to ensure successful inspection preparation and execution in support of Crinetics' Pharmaceutical Establishment License (Trade Abroad).

This position will also be responsible for supporting the launch of Crinetics products in the EU/EEA and Switzerland from a quality perspective. This includes adapting the global QMS to ensure compliance with EU and CH requirements, managing our EU/EEA and Switzerland quality service providers, leading external/internal audits in these regions, performing lot release activities, and developing collaborative partnerships internally, as well as externally with global contract organizations and strategic partners, as needed. This individual will be an integral part of the company's effort to develop and commercialize small molecule therapeutics for rare endocrine disorders and endocrine-related tumors in the EU/EEA and Switzerland.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Be an active member of the work teams involved in the EU/EEA launch activities as these evolve
• Manage external quality agencies and quality vendors across the EU/EEA and responsible for the maintenance of licenses to operate across Europe
• QA Lead for EU/EEA market actions, such as stock recovery, recall and reporting processes, including notifications to regulatory authorities, partners and Responsible/Qualified Persons (RPs and QPs) as appropriate
• Manage consultants, contracts, Responsible Persons and Qualified Persons across the EU/EEA (Ex. Switzerland, Ireland, Germany) as assigned
• GMP oversight for EU commercial activities related to labeling, serialization, and support around randomization, and blinding for clinical trials
• Support ex-US supply chain compliance requirements for clinical (direct to patient, just-in-time and depot models) and commercial distribution
• Maintain and improve the global Quality Management System and provide an on-going assessment of Quality Management System health and effectiveness
• Create and review policies, procedures, work instructions and other supporting documentation
• Enhance quality metrics, key performance indicators, and dashboards to monitor the global QMS performance, drive continuous improvement, and report into QMR
• Collaborate with CMC and RA in the implementation of product specifications at vendors and for regulatory filings
• Responsibility for identifying GMP and GDP risks, developing mitigation plans
• Perform and/or oversee QP release for batches of drug product and, as needed, perform batch review and release for Drug Substance, Drug Product, Packaging and labeling runs at Contract Manufacturing Organizations
• Evaluate, audit, and support vendor lifecycle with external parties (CMOs and other Service Providers); Review Quality Agreements and negotiate on Crinetics behalf
• Author, review and implement changes through appropriate Change Management and assess impact of changes to regulatory filings
• Participate in risk assessment, vendor selection and qualification, inspection activities, and maintain the inspection process for GMP & GDP at Crinetics
• Perform internal audits, as needed
• Oversight for GMP Quality Events (Complaints, Deviations, CAPAs) processes with appropriate escalation of Major and Critical events with potential to impact patient safely, product quality or supply delays
• Serve as Project Manager for assigned process improvement initiatives, projects and teams, such as Change Control, GMP QMR sections etc.
• Represent QA in internal and external team meetings
• Stay current of cGMPs, industry trends, practices, and regulatory guidelines
• Actively manage and coach direct reports by encouraging professional and personal development, leading by example and nurturing individual growth to optimize team performance
• Other duties as assigned

Education and Experience:

Required:

• Bachelor's degree or Master's degree with scientific or technical discipline
• A minimum of 15 years of relevant Quality Assurance GMP experience in a biotech/pharmaceutical setting with 10 years of supervisory leadership, continuous improvement and/or project management experience; an equivalent combination of experience and education may be considered.
• Demonstrated knowledge of EMA/FDA/ICH and Dutch standards and regulations, committed to continued training
• Involved in the setup of new biotechnology/pharmaceutical companies from early phase
• Fluent in Dutch and English
• Experience working with Contract Manufacturing Organizations and/or auditing CMOs
• Experience with large stakeholder management, QMR, and reporting out to senior management teams
• Demonstrated knowledge of EU commercial serialization requirements Falsified Medicines Directive (FMD) and its associated Delegated Regulation (DR) as well as clinical blinding (randomization)
• Previous history of performing or coordinating a Qualified Persons (QP) release process to streamline efficiency within global clinical supply chain
• Experience implementing a just-in-time (JIT) or Pooled Material Supplies (PMS) clinical supply chain
• Experience at a global level with product complaint, stock recovery, EU quality defect and recalls reporting processes
• Demonstrate ability to effectively organize, prioritize and work in a fast-paced environment
• Demonstrate ability to function individually and in a team environment
• Strong project management skills with ability to manage multiple projects and execute in adherence to timelines
• Must be able to communicate effectively with all levels of personnel as well as with Contract Manufacturing Organizations
• Software knowledge: MS Office, DocuSign, electronic QMS systems

Preferred:

• Eligible to act as a Qualified Person in the Netherlands, including a master's degree in pharmacy. medicine, veterinary medicine, chemistry, pharmaceutical chemistry or technology or biology, obtained in the EU or outside the EU subject to a NUFFIC certification demonstrating equivalence, with minimum 5-years operating as a QP on an EU Manufacturing Importation Authorization
• Solid dosage or drug substance 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 20% of your time.