Quality Assurance Director, Clinical

Quality Assurance Director, Clinical

W2 Contract

Salary Range : $187,200 - $208,000 per year

Location : Berkeley, CA - Hybrid Role

Job Summary :

You will be responsible for leading the development, implementation, and maintenance of quality assurance (QA) systems and activities to support quality oversight in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Pharmacovigilance (PV) operations.

This role will include ensuring clinical trials comply with relevant regulations and guidelines, developing internal procedures, training staff, hosting regulatory inspections, and managing clinical quality operations.

You will audit service providers, study sites, and internal processes, manage quality-related activities with clinical vendors, investigator sites, and regulatory agencies, and maintain inspection readiness.

You will work independently, represent QA in team settings, and drive continuous process improvement.

Duties and Responsibilities :

• Ensure that all clinical trial activities comply with guidelines, international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws.
• 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 ensure appropriate and timely documentation of quality event management, including CAPA plans supporting product pipeline.

• Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensuring implementation and preparing 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.
• Maintain and enhance our Quality Management System (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 Standard Operating Procedures (SOPs) suite, quality manuals, policies, and other related quality documents.

Ensure that relevant stakeholders effectively communicate, understand, and follow these systems.

Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations.

Conduct risk assessments, develop risk mitigation plans, and oversee 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 quality standards, regulations, and procedures training.

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 management review highlighting quality performance, trends, and areas for improvement.

Assist with tracking compliance audit trends and present them 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, procedures, requirements, standards, and guidelines.
• Lead and manage additional Quality Assurance (GxP) initiatives or programs as business needs evolve.

Requirements and Qualifications :

• Undergraduate or graduate degree in Biological Sciences, Chemistry, or related Science discipline
• 15+ years of experience in clinical quality assurance (GCP, GLP, and PV) in cell and gene therapy / biotechnology or the pharmaceutical industry.

Experience working in biologics is strongly preferred.

• Subject Matter Expert (SME) working knowledge of current interpretation / implementation of the United States Code of Federal Regulations, ICH Guidelines, and other local government regulatory requirements governing clinical research.
• A 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 provider (vendor) audits, clinical investigator site audits, CSV audits, and process audits.
• Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
• Excellent verbal and written communication skills; ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality, and advocate for quality and regulatory compliance.
• Highly diplomatic and tactful with excellent critical reasoning skills.
• Conscientiously detail-oriented and organized with impeccable attention to data review.
• Able to deal with ambiguity and use expertise and skills to contribute to developing company objectives and principles and achieve goals creatively and effectively.
• 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) or GCP (e.g., Certified Clinical Research Professional) is desired.
• Open to occasional travel for vendor audits as needed

Desired Skills and Experience

Quality assurance, Good Clinical Practice, ICH-GCP, ICH-PV, FDA, SOPs, QMS, biotechnology, pharmaceutical, biologics

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