Director/Senior Director, Clinical Quality Assurance

Annexon • San Francisco, CA

351d • $199,000 - $272,000

About The Position

Annexon Biosciences seeks a Director/Senior Director, Quality Assurance (QA) to lead the company's clinical Quality Assurance (cQA) program. 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 Annexon's functional areas. The candidate will perform audits of service providers, study sites, and internal processes. The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP focused team setting and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Annexon's clinical stakeholders and act as a catalyst for continuous process improvement.

Requirements

• Undergraduate or graduate degree(s) in Pharmaceutical Sciences, Chemical Engineering, or related discipline.
• At least 10 years of experience in clinical quality assurance in biotechnology and/or pharmaceutical industry.
• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
• 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.
• Excellent verbal and written communication skills.
• Ability to lead cross-functional teams and independently prioritize work.
• Fastidiously detail-oriented and organized, impeccable attention to data QC.
• Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles.

Nice To Haves

• Experience working in biologics is strongly preferred.
• Highly diplomatic, and tactful individual with excellent critical reasoning skills.
• Flexible and able to multitask, prioritize, meet deadlines in a fast-paced environment.

Responsibilities

• Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams.
• 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 and EU regulations/directives/requirements and ICH guidelines.
• Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents.
• Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations.
• Build training curricula based on the key elements of the Quality System.
• Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments.
• Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards, and guidelines.
• Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management.
• Lead and/or manage additional Clinical Quality Assurance (GCP) initiatives or programs as needed.

Benefits

• Flexible work schedules.
• Remote opportunities.
• Ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Competitive base salary and equity participation.
• Employee stock purchase plan.
• Comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees