Emeryville, California, 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 Senior Director, Clinical Quality will provide strategic direction, operational delivery and Quality oversight of Zogenix's Clinical Development programs and ensure compliance with global GCP regulations. The role will partner with Clinical Operations and Clinical Science to provide strategic, tactical, and operational guidance regarding GCP compliance with current pharmaceutical laws and regulations. The Sr Director will be instrumental in integrating quality throughout all steps of the clinical study process, including monitoring, auditing using risk assessments, and trending key metrics to drive continuous improvement in compliance and quality. In addition to the primary GCP Quality oversight responsibilities, this role will also support GLP and GVP activities with respect to Quality oversight. This leadership role will sit on the global Quality Leadership team at Zogenix and will lead a team of Quality experts. The Quality team supports Zogenix throughout the product development and commercial life cycle by providing appropriate knowledge/expertise/oversight and communicating effectively with internal and external stakeholders to ensure that Zogenix operates within relevant regulations.
PLEASE NOTE – this is a REMOTE position Responsibilities
Build, develop and manage a high performing Quality team with focus on retaining and developing key talent. Ensure appropriate resources to meet all business objectives.
Lead efforts to develop and implement full clinical site qualification program through development of GCP auditing system and partnership with Clinical Operations team.
Perform CRO supplier risk assessments in support of QA Vendor qualification program. Establish audit plans and annual CQA audit plan. Execute GCP and GLP compliance audits, including clinical investigator sites, contract research organizations (CROs) and contract clinical laboratories to determine compliance status and identify compliance risks.
Provide leadership and guidance to Quality teams for oversight of GCP, GLP, and PV activities at Zogenix and its investigator sites and contract research organizations for clinical and nonclinical studies; collaborate with Clin Ops and external partners to effectively and efficiently set up the overall GCP oversight programs.
Maintain an effective Quality governance and continually improve governance to meet business and compliance needs. Serve as a subject matter expert to the company on GCP Quality related issues by communicating proactively and effectively with cross-functions at all levels.
Collaborate with Clinical Science and Clinical Operations functions to confirm adherence to GCP compliance through all stages of clinical trial conduct including but not limited to core study execution documents, clinical trial sponsor oversight, issue escalation, internal/external audit support.
Review supportive clinical trial documents (manuals, study plans) for compliance with regulations. Ensures appropriate CAPAs and risk mitigation activities as necessary.
Implement and maintain SOPs pertaining to Quality of GCP related activities and overall QMS with focus on development programs. Effectively identify quality and compliance issues, actively resolve issues, recommend solutions and provide Clinical QA guidance across functions.
Actively lead and participate in inspection readiness activities and prepare/train other entities for a successful inspection. Host and participate in relevant external and regulatory authority inspections. Respond to and resolve issues relating to inspection findings. Provide GCP/GLP training to functional areas and ensure the content satisfies regulatory requirements and GCP guidelines..
Effectively communicate key quality metrics and build a culture of quality across the organization.
Serves as a strategic partner to internal and external business partners in driving innovative approaches for issue management within clinical development and credible thought leadership regarding CAPA and processes.
Define and operate within approved operating budget
Support the Company's project teams and assist with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner
50% Travel (domestic and international)
Requirements
Bachelor's Degree in a life science-related discipline or related field
Advanced degree (PharmD or PhD) preferred
12+ years of experience in the pharmaceutical/ biotechnology industry. Broad experience across Quality, PV, Regulatory affairs and Development desired.
Minimum 8 years of comprehensive experience in GCP Quality Assurance with 5+ years in management role
Experience in global settings including interaction with various Health authorities highly desired
Strong proven hands-on experience with a variety of GCP compliance matters and contractor management in the bio/pharma industry
Experienced in handling multiple heath authority inspections (FDA, EMA etc)
Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs
Strong knowledge of US and other major global (ICH, EU, Asian) Clinical regulatory compliance requirements
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Ability to multi-task in a very fast-paced environment, with maturity and experience in making high impact decisions and communicating effectively with senior executives.
Must be able to effectively collaborate with peers and comfortable working in a matrixed team
Must be solutions oriented and pragmatic (with analytical thinking and problem-solving skills)
Excellent project management and organization skills is a must
Excellent communication skills (verbal and written) and interpersonal skills.