Associate Director, Computer System Validation and Data Integrity
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, Computerized Systems and Data Integrity, Quality will be responsible for overall quality oversight of computerized system validation and data integrity ensuring compliance to quality objectives and regulatory requirements. The position will work closely with Clinical Operations, PV and IT and other teams to ensure compliance of cGxP systems. This role is pivotal to Life cycle management of Computerized Systems across GxP, internally hosted or vendor managed.
The role will serve as a subject matter expert implementing Data Integrity programs and providing direction and training to the organization. The role will also be responsible for implementing quality policies, processes, and procedures to ensure CSV and Data Integrity at Zogenix.
Essential Duties and responsibilities
- Provide QA and computer system life cycle oversight for GXP computerized systems and apply risk-based methodology to validation/qualification efforts in compliance with appropriate regulations.
- Oversee the overall readiness of the CSV and Data Integrity programs to ensure programs are compliant, effective and ready for regulatory inspections.
- Design, implement and monitor a company wide data integrity program. Identify KPIs for effectiveness.
- Assess systems for data integrity and compliance with regulatory expectations including assessment of third party IT service providers and application vendors. Audit, monitor and manage 3rd party/vendors engaged to perform CSV and data management activities.
- Effectively identify and resolve complex system issues and appropriately communicates gating items to senior management and stakeholders.
- Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
- Participate in and support the external audit program for vendors related to GXP computerized systems. Ensure proper CAPAs, closures and QAAs for all such systems and services.
- Participate and be the CSV and DI QA SME in cross-functional project teams.
- Evaluate and recommend QA process changes by keeping abreast of the requirements for compliance in own area of work.
- Drive execution through a risk-based approach work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.
- Lead or support the development of procedures, work instructions, validation templates and training materials to ensure that the control of GxP computerized systems are integrated into the company’s quality management system.
- Collaborate with the IT Delivery Team, business users and internal Global Quality compliance staff to ensure that CSV activities are planned and executed in accordance with internal procedures.
- Actively supports Inspections and audits (internal and external)
- Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- In-depth knowledge and experience of computerized system lifecycle activities, CSV and IT controls in a regulated environment.
- Thorough experience with FDA inspections and the criteria required for a successful audit outcome from a CSV perspective.
- Comprehensive expertise and working knowledge of GxP, 21 CFR Parts 11, GAMP 5, Annex 11 and Data Integrity compliance requirements.
- Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state.
- Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles.
- Excellent verbal, written and interpersonal communication skills.
- Strong organizational skills, planning skills and must work effectively within teams.
- Must work effectively within teams with rapidly changing priorities.
- Must be able to independently represent the QA organization in a wide assortment of situations.
- Must possess strong leadership skills to work cross functionally and build strong business relationships with cross-functional teams and leadership.
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 Computer Science or related field.
- 8+ years of relevant progressive experience, preferably within the pharmaceutical/biotech industry. Proven experience implementing and overseeing CS and DI as Quality function.
- In depth experience providing Quality oversight over vendor managed CS, and data management services.
- Audit certifications desired. Demonstrated experience planning, conducting and managing audits over a wide variety of software vendors across GxP.
- Solid knowledge of US and global regulated markets (FDA, MHRA, EMA, CFDA, etc.).
- Minimally 6+ years' experience with CSV in a life sciences, biotechnology or pharmaceutical company required, including GAMP5 experience, and strong understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and data integrity.
- Expertise in risk management principles, building a quality culture and implementing methodologies to measure and improve.
- Experience working in global environments, with complex supply chains and international partners and health authorities highly desired.
- Experience across different modalities (small molecules, biologics, ATMPs) desired.
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 20% travel as required.