Quality Assurance Manager at Teva Pharmaceuticals ensuring compliance with pharmaceutical regulations and improvement of quality metrics. Leading deviation investigations and regulatory inspections throughout the scope of responsibility.
About the role
- Director of Quality Assurance at Caribou Biosciences leading development and compliance of QA systems in clinical settings. Focusing on quality oversight in cell and gene therapy and biotechnology.
Responsibilities
- 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. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
- 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. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
- 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, to ensure alignment and integration of quality assurance activities. 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 with at least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry.
- 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.
- The position requires a 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, and to achieve goals in creative and effective ways.
- Must be flexible and able to multi-task, prioritize, meet deadlines in a fast-paced environment, and be 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.
Benefits
- 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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