Sr. Manager, Clinical Quality Assurance
Location: Emeryville, CA
Department: R&D Quality
Quality is the primary guiding principle at Zogenix. It is the foundation on which all functions and activities are performed. Excellence in the management of quality is fundamental and the foremost aspect upon which the Pharmaceutical Operations team are judged by our patients, caregivers, partners, colleagues, and regulatory bodies. Our commitment is to go beyond compliance and operate effective quality, development, operations, and supply systems that result in excellent products, processes, innovations, and documentation to ensure satisfaction from all stakeholders. We are committed to providing therapeutic solutions with potential to transform the lives of patients and their families living with serious rare diseases.
The Sr. Manager, Clinical Quality Assurance will play an essential role in developing and managing the GCP QA program to ensure that clinical trials are conducted in accordance with cGCP regulations, ICH guidelines, and any country specific regulations that might impact the clinical trial. This position will be responsible for ensuring that all clinical studies are performed in compliance with Zogenix procedures and protocols, FDA guidelines and regulations, and ICH guidance and regulations. The position is also responsible for execution of internal and external audit plans and activities, and the development and maintenance of GCP-related quality systems across the company.
- Support Clinical Quality Management System (CQMS), for GCP QA in compliance with applicable regulatory requirements (US and OUS), and company policies
- Participate in Zogenix clinical operations teams study meetings
- Collaborate with clinical operations study leads to ensure Sponsor Oversight is maintained and improved in ongoing clinical programs
- Support inspection readiness efforts
- Support the coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections
- Ensure clinical trials are performed in accordance with applicable study protocols and in compliance with cGCP and ICH guidelines through active monitoring of clinical sites
- Participate in the clinical supplier qualification program to ensure Sponsor Oversight of vendors
- Participate/Lead audits and reviews of clinical study documents, including but not limited to Investigator Brochures, Clinical Protocols, Clinical Study Reports, Case Report Forms, Informed Consent Forms
- Work with CROs to create, and keep current, Quality Agreements, Monitoring Plans, etc., to ensure quality standards are met, and resolve issues promptly and effectively
- Ensure timely execution of the cGCP Audit Plan. Support/Lead GCP Compliance audits of Investigator Sites, Clinical Research Organizations (CROs), and vendors in accordance with the Audit Plan
- Support the administration of the company’s training program as it applies to Clinical. Conduct and document cGCP training for clinical team members, investigators, clinical site staff, and company employees as required
- Provide oversight of contractors and consultants to ensure timely and quality deliverables.
- Other duties as assigned.
- B.S. degree or an equivalent amount of relevant experience
- 7+ years of experience working within the Clinical Operations, Regulatory, or Quality environment in the pharmaceutical or biotechnology industry
- Working knowledge of Local, State, Federal, and international regulations pertaining to GCP, ICH guidelines, and HIPAA requirements across the world
- Thorough understanding of Regulatory compliance requirements for the US FDA, and the European Union
- Auditor training/experience or certification
- Must be a self-starter and a results and goal oriented person
- Ability to effectively prioritize various projects based on timelines and importance
- Excellent written and oral communication skills
- Accuracy and attention to detail
- Managing contractors
- Excellent cross-functional team participation skills
- Outstanding problem-solving qualities
- Ability to grasp new technologies
Special Working Conditions
- Ability to travel up to 50% of the time