We are seeking an Associate Director/Director of Quality Assurance, Good Clinical Practice (GCP), to join our growing Quality Assurance group. This position is responsible for establishing and directing GCP Quality Assurance (QA) functions focusing on Good Clinical Practice (GCP) compliance for development products. This role will engage and collaborate with cross-functional internal and external teams to evaluate processes, procedures, and activities to comply with relevant industry standards, regulatory requirements, and company Standard Operating Procedures (SOPs) as appropriate. This position will conduct internal and external GCP audits of investigator sites, vendors, clinical study reports, investigator brochures, and clinical submission documents, etc. This role will lead or assist in inspection readiness activities and QA oversight and support of all phases of clinical studies with an emphasis on studies conducted in phase 1 units (First in Human (FIH), etc.). This position works cross-functionally with internal departments and external resources on GxP QA-related issues and may have direct reports. The role may be hybrid or remote with occasional visits to the Company’s offices in Berkeley, CA.
Partners with Clinical Research/Operations and actively participates in clinical study teams to ensure GCP compliance. Identifies and communicates clinical trial-related risks and opportunities for process improvement. Reviews study-related documents and plans
Performs internal and external audits as assigned to assure compliance with GXP regulations and guidelines
Communicates audit results to internal stakeholders and prepares audit report.
Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs)
Leads and/or participates in regulatory authority inspections and conducts GCP inspection readiness activities
Manages, coaches, and mentors direct reports
Performs other tasks and assignments as needed and specified by management
Bachelor’s degree in a scientific discipline and a minimum of 7 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
Detailed knowledge and understanding of GCP regulations
Demonstrated experience leading and/or conducting Clinical QA audits
Demonstrated experience developing and executing risk-based audit plans
Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors
Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports
Experience supporting regulatory agency inspections
Excellent verbal and written communication and skills
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
Experience writing and reviewing SOPs
Clinical lab experience preferred
Registered GxP Quality Assurance Certifications preferred
Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections preferred
Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Pharmacovigilance Practice (GVP) regulations preferred
Up to 30% travel
Caribou compensation and benefits include:
Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees
Generous paid vacation time, in addition to company-observed holidays and floating holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Tuition reimbursement program
Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Caribou requires employees to be fully vaccinated, including a booster shot, against COVID-19 unless they have an approved medical or religious accommodation. Proof of such vaccination will be required as part of the hiring process.
For more information about Caribou, visit www.cariboubio.com and follow the company @CaribouBio.