Position Summary

Our client seeks a Quality Assurance (QA) Director/Senior Director 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 Company’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 Company’s clinical stakeholders and act as a catalyst for continuous process improvement.

Responsibilities

• 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 the Annexon 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 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. 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 operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
• Build training curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to clinical quality assurance. 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 clinical quality assurance activities. Prepare regular reports and presentations for senior/executive management highlighting quality performance, trends, and areas for improvement.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical 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 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.

Key Qualifications

• Undergraduate or graduate degree(s) in Pharmaceutical Sciences, Chemical Engineering, or related discipline with at least 10 years of experience in clinical quality assurance in biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred
• 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, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance.
• Position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills.
• 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, and to achieve goals in creative and effective ways.
• Must be flexible and able to multitask, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks.