Director, Clinical Quality
Location: Emeryville, CA
Department: R&D Clinical Quality
Quality is our 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 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 Quality function within the Pharmaceutical Operations (PharmOps) team is responsible for integrating, executing, and inspiring Quality throughout all functions at Zogenix.
The Director, Clinical Quality Assurance is responsible for development, governance and management of GCP and ensuring other product development and PV activities comply with applicable international and national standards, regulations and guidelines. The incumbent will provide support and promote collaboration internally to ensure all systems, processes and their outcomes remain compliant. The position will provide quality oversight of multiple programs in development, based on company goals.
MAJOR AREAS OF RESPONSIBILITY
- Manage Clinical Quality oversight, including creation and revision of SOPs and training programs for GCP
- Ensure involvement of Quality from early phases of development through collaboration with Clinical Science, Clinical Operations, RA, PV etc to influence effective processes and program oversight.
- Lead in preparation and support of regulatory inspections and partner diligence audits in cooperation with multiple internal functions as well as external vendors/3rd Provide training and support for site inspections as well as CROs and service providers.
- Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial “essential documents” (e.g. protocols, ICF, )
- Evaluates vendors for potential use; conducting and/or managing qualification inspections of GCP suppliers and service
- Create and execute clinical study audit plans, perform routine and for cause audits of clinical investigator sites, and review of TMFs and
- Lead and participate in cross functional working groups to identify and mitigate GCP quality and compliance Create, monitor and improve a QMS with focus on development phases.
- Oversee GCP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data
- Lead, investigate and/or oversee quality issues including CAPAs and closures including defining and monitoring key quality metrics in support of management reviews.
- Participate in department cross-training and lead/support during regulatory inspections, serving as QA clinical expert and host inspections as needed. Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures.
- Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs.
- Other duties as assigned.
- Minimum Education requirement of a BSc/MSc or equivalent in a relevant scientific Graduate level in a science or engineering related discipline is preferred.
- In‐depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations, guidelines, and best practices
- 10+ years’ experience in clinical quality assurance ensuring sponsor oversight including performing GCP audits for clinical stage pharmaceutical companies with at least 5 years’ experience in an out-sourced Thorough experience in quality function, overseeing clinical quality within European guidelines and regulatory standards.
- 5+ years’ experience with Pharmaceutical Quality Assurance in the US. Strong HA inspection experience with FDA, MHRA, EMA, and/or PMDA is desirable.
- Possesses a thorough knowledge of GCP's and other relevant regulations in US and
- Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice and Good
- Additional certifications as an auditor as well as training regulatory frameworks highly desirable.
- Expertise in data integrity and CFR Part 11 required.
- Has a bias for action and display a sense of Must possess strong skills in leadership, communication, project management, and budget management.
- Demonstrated ability to collaborate, communicate and ensure quality oversight through external parties.
- A working knowledge of databases, including Electronic Document Management Systems (EDMS), is
SPECIAL WORKING CONDITIONS
- Travel (domestic and overseas) up to 25%, or as needed.