Director of Quality Assurance, Clinical Job at Caribou Biosciences (Berkeley)

Job Description

Responsible for leading in the development, implementation and maintenance of QA systems and activities supporting quality oversight towards GCP, GLP, and PV operations. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Company’s functional areas. The candidate will perform audits of service providers, study sites, and internal processes.

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders
Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations
Build training and approve curricula based on the key elements of the Quality System
Provide leadership and oversight for training programs related to pre-clinical, clinical and PV
Establish and monitor quality metrics and key performance indicators for the effectiveness of pre-clinical, clinical, and PV quality assurance activities
Prepare routine reports and presentations for senior/executive management review highlighting quality performance, trends, and areas for improvement
Assist with tracking compliance audit trends and present to management
Collaborate with cross-functional teams, including pre-clinical, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments
Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers
Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and requirements, standards, and guidelines
Lead and/or manage additional Quality Assurance (GxP) initiatives or programs as business needs evolve

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work
Manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance
Highly diplomatic, and tactful individual with excellent critical reasoning skills
Conscientiously detail-oriented and organized
Impeccable attention to data review
Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles
Ability to achieve goals in creative and effective ways
Must be flexible and able to multi-task, prioritize, meet deadlines in a fast-paced environment
Adaptable to setbacks
Detail-oriented mindset with a proactive approach to problem-solving and decision-making
Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable
Ability to travel up to 25-30% based on business needs

Nice to have

Experience working in biologics
Prior GLP experience with quality oversight and auditing studies/vendors
Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional)

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

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Director of Quality Assurance, Clinical

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