Sr. Director, Quality Systems and Compliance
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 Senior Director, Quality Systems and Compliance will provide management and overall strategic direction and operational ownership of the Quality Management System at Zogenix. The Senior Director, Quality Systems will ensure compliance with all applicable global regulatory requirements and alignment with company objectives and Quality Standards. This role will directly be responsible for ensuring that the company’s Quality Systems enable and facilitate compliance in a phase-appropriate manner (pre-clinical through commercial). This role will oversee all aspects of Quality Management System such as inspection and audit management, Complaints, Documentation, CAPA, Change control, training, QMRs, as well as supplier management and data integrity. As a key member of the Quality Leadership team, this role will heavily influence and support building a culture of quality and a “right first time” mindset.
The position will build a strong and talented team within Quality; focusing on attracting and developing strong talent with core skills and competencies to meet business needs.
Essential Duties and 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.
- Accountable and Responsible for the Quality Management System at Zogenix; ensure phase appropriate QMS built on a framework of procedures/ policies and management responsibilities
- Serve as a primary contact for audits and regulatory inspections, with responsibility to oversee and prepare appropriate documented responses and corrective actions.
- Interpret CGMP regulatory requirements and provide guidance for effective compliance, as well as providing support for programs and projects leading to the successful approvals
- Develop, communicate, and influence a culture of quality; define Quality systems encompassing Documentation, Training, QMRs, Deviations and CAPAs, Supplier Management, Risk Management and Compliance
- Develop quality policies, goals, objectives and collaborate and communicate across the company
- Oversee the design, development, roll-out and maintenance of Global GxP e-Quality Systems, ensuring compliance to regulatory requirements, policies, standards, and procedures, as they relate to computerized systems, data integrity, and validation.
- Ensures that the Quality Management System is maintained in accordance with current regulatory compliance requirements and meets company objectives.
- Responsible for developing and conducting the GxP training programs, Inspection readiness programs, Internal/external audit programs.
- Develops a process for identification and management of the top compliance risks across GMP functions, which will also include analysis of audit & inspection data.
- Actively monitors the risk register and report on status to Executive Management and incorporates continuous improvement into annual Quality Plans.
- Create, facilitate, and manage required QMS meetings including Review Boards and Quality Management Review.
- Responsible for operational support for key quality systems (e.g. Complaints, document management, training and change control).
- Interacts effectively with company management, internal departments, and other sites to implement and maintain the company Quality System.
- Identify and implement continuous improvement projects related to the Quality Management System and compliance
- Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- Proven QA compliance experience including successful implementation and oversight Quality Management System including but not limited to, internal and external audit programs, supplier management programs, inspection readiness and health authority inspection management
- Expert knowledge in worldwide regulations and the ability to interpret and implement these requirements.
- Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, with focus on patient health and company reputation
- Strong analytical, communication, and negotiation skills as well as sound judgment, with the ability to work effectively with multiple functions and competing priorities
- Ability to manage conflict; influence right first time behaviors and thoughtful action.
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment and develop productive relationships with external vendors
- Self-motivated with ability to plan, organize and prioritize multiple tasks and able to perform under pressure to meet production
- Ability to deal with ambiguity, creative and pragmatic approach to problem
- Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight.
- Ability to think strategically and to influence others
- Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks.
- Bachelor’s degree in a scientific or technical discipline,
- 12+ years of progressive experience in biotechnology or pharmaceutical industry; Leadership experience in building high performing teams required
- Experience working with Quality systems in support of early and late stage development
- Extensive experience in clinical and commercial GMP environments, focused on Quality.
- In-Depth experience building, integrating and maintaining Quality Management Systems, QMS, with corporate systems.
- Developing and implementing compliance related metrics for Quality Management Review and compliance tracking.
- Experience in regulatory intelligence program implementation.
- Extensive experience in regulatory inspections (domestic and international)
- 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.
Licenses or Certifications
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 30% travel as required.