Associate Director, Audits and Inspections
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 Associate Director, Audits and Inspections is responsible for preparing, organizing, and leading inspections conducted by global Health Authorities. This role is a key member of the Inspection Readiness teams supporting operational strategies and direction for domestic and international inspections. Senior Manager, Inspection Management coordinates responses to regulatory inspections; shares best practices and lessons learned following inspections; and works with department leaders to build an inspection readiness capability across the organization. The position is also responsible for managing and motivating team members, building trust and cultivating a collaborative environment. As a member of Quality organization, this role influences and supports various functions in taking correction and preventive measures and building a systems-based thinking.
Essential Duties and responsibilities
- Lead inspection readiness activities for Zogenix legal entities; ensuring inspection preparedness across GxP with regards to training, QMS, and hosting responsibilities.
- Develop and execute audit management training for subject matter experts and all site
- Establish and maintain inspection management processes and procedures
- Coordinate pre-audit and inspection activities including documents and information needed from various functions and suppliers/CMOs.
- Liaise with Clinical Ops, Tech Ops, Regulatory Affairs, PV Team and other key stakeholders
- Conduct mock inspection interviews focused on subject matter expert role-based content as well as general inspection conduct
- Improve and implement efficient methodologies and tools for the handling of internal audits, regulatory audits, and follow up on CAPAs. Perform self-inspections/Internal audits as needed.
- Monitor and trend Corrective and Preventative Actions (CAPA) from findings/observations due to audits, inspections, and quality events. Facilitate resolution and prevention of repeat findings through training, oversight and collaboration with various functions and subject matter experts.
- Proactively prepare for inspections based on corporate goals. Lead and support key inspection activities including hosting, running, back room support and other as needed.
- Train and support the organization in being inspection prepared at all times; with ownership and culture of compliance to quality processes and standards.
- Inspection Readiness:
- Assist with audits and inspections including developing timely responses to observations and oversight of corresponding CAPAs
- Manage Health Authority inspection preparation activities and provide leadership and oversight during inspections.
- Promote a Corrective and Preventive Action (CAPA) system for findings/observations due to regulatory inspections, including developing reports for trend analysis. the spirit of proactive, continuous quality improvement
- Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- Must have expert GMP, Quality, and risk management experience.
- Provide leadership and oversight during Health Authority inspections.
- Must be able to critically interpret results and determine the desirability of new or additional content to maintain the effectiveness of QMS.
- In depth experience in inspection management activities and SME experience during audits.
- Strong at conflict management and providing constructive feedback
- Capable to interpret information/data to provide guidance regarding superior business solutions, largely in the form of influencing strong corrective and preventive actions as a result of audit/inspection findings
- Ability to construct narratives and train the organization on audit readiness activities.
- Self-starter with demonstrated ability to work independently and in a matrix, team environment
- General understanding of quality systems and regulatory obligations from clinical trial to post marketing phases
- Appreciation of sense of urgency and prioritization of multiple projects and timelines
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment and develop productive relationships with external vendors
- Bachelor’s degree in a scientific discipline or equivalent education and experience.
- 9+ years pharmaceutical experience with a strong preference of 5 or more years in quality and/or regulatory.
- Experience in planning, organizing and executing effective audits/inspections
- Experience authoring audit reports, investigations, quality agreements, and risk assessments.
- Experience in global environments, interacting with multiple health authorities.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
- Ability to work on a computer for extended periods of time.
- Regularly required to sit for long periods of time, and occasionally stand and walk.
- Regularly required to use hands to operate computer and other office equipment.
- Close vision required for computer usage.
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds.
- Up to 25% travel as needed.