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Crinetics Pharmaceuticals · 5 days ago

Director, Quality Assurance GCP

United States

Full-time

Onsite

Director/Executive

$180K/yr - $225K/yr

12+ years exp

Crinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases. The Director of Quality Assurance (GCP) oversees the development and performance of GCP Quality Assurance systems, ensuring adherence to regulatory requirements and leading the QA team.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Provide GCP quality assurance strategy and oversight of QA GCP operations

Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies

Develop and implement risk management strategies to identify, assess, and mitigate risks

Drive effective initiatives that foster a culture of quality and continuous improvement

Successfully collaborate on multiple projects with cross-functional stakeholders

Lead investigations of significant complexity

Prepare and present to executive management

Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects

Develop a plan with CROs for clinical sites’ audit execution

Manage clinical site, TMF, and GCP and GLP vendor audit activities

Generate and/or review and approve overall GCP QA audit plans and schedules

Generate and/or review and approve audit trend reports

Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends

Represent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback

Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and responsible for informing the head of QA and Management, as required

Manage quality events, CAPAs, and deviations

Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs

Provide guidance and support to Trial Master File activities

Ensure adequate systems and controls are in place for GCP compliance

Identify and address quality systems gaps, including internal processes and personnel GCP training

Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs

Author, review, or revise SOPs related to clinical and non-clinical studies

Develop and provide GCP training

Support regulatory inspection activities

Prepare internal team, clinical sites, and vendors for inspection readiness

Thoroughly review clinical study documents

Perform breach assessments

Oversee quality vendor management and governance for GCP and GLP vendors

Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor

Contribute and present GCP quality events and metrics at the Quality Management Review meeting

Support other Quality Assurance and Quality Systems activities

Other duties as assigned

Qualification

GCP Quality AssuranceRegulatory complianceAudit managementRisk managementGCP procedures developmentLeadershipCross-functional collaborationListening skillsAuditing certificationCommunicationProject management

Required

Minimum Bachelor's degree in a science discipline and at least 12 years' experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)

Minimum of 8 years of working in a GCP QA function

Previous experience leading inspection readiness and audits

Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines

Hands-on experience in developing and implementing GCP procedures

Strong working knowledge of GCP and GLP regulations

Proven ability to cultivate and develop relationships with cross functional teams and vendors

Demonstrated leadership ability to identify, manage and develop QA teams

Must be able to make critical and strategic decisions based on risk-assessments

Capable of managing multiple projects simultaneously

Excellent communication and listening skills