Director, Compliance and Metrics
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 Director, Compliance and Metrics is a key member of the Quality organization, responsible for planning, implementing, and measuring the compliance framework through programs and procedures, defining KPIs for quality, inspection management and management reviews. This role will support the QMS through creation of policies and procedures and building a culture of quality throughout the company. This role is also be responsible for specific procedures and programs focused around data integrity, network compliance and continuous improvement.
Essential Duties and responsibilities
- Responsible for defining, implementing and monitoring a framework that ensures compliance to regulatory expectations and builds a culture of continuous improvement.
- Oversee performance and delivery of quality commitments in alignment with Quality strategies and with focus on continuous improvement
- Develop and implement risk management processes for identifying and prioritizing areas of compliance risk and allocating appropriate resources to manage that risk
- Lead and support domestic and international Health Authority Inspections
- Advise on robust remediation and resolution of deficiencies identified through internal audits, inspections and otherwise; follows up on closure of corrective and preventive action plans
- Define and maintain Quality metrics and key performance indicators at required levels to engage multiple functions and measure the effectiveness of QMS
- Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
- Collaborate cross functionally to identify, publish and adhere to a yearly audit schedule designed to measure and improve systems compliance internally and throughout the external network (CMOs, CROs, Vendors etc.).
- Ensure that the QMS is built to identify a risk-based approach towards product life cycle activities and identify quantitative and qualitative measures.
- Participate in the development, implementation, and maintenance of procedures, tools and templates to assist in the evaluation of 3rd parties involved in GxP activities with Zogenix. Proactively build relationships with these entities for timely and effective collaboration and responsiveness.
- Create, manage and communicate key risks via Quality risk management.
- Promote, awareness across the commercial and clinical manufacturing teams of current regulatory expectations and trends.
- Drive consistency with audit report observation writing, classification, status, and overall risk
- Lead key activities such as mock inspections, mock recalls, internal and supplier audits as needed.
- Proactively identify and alert the organization of quality or compliance concerns in time to resolve adverse impact to the patient and company reputation
- Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- Thorough knowledge of FDA/EMA regulations and an ability to quickly understand and interpret new market requirements.
- Must be capable of assessing compliance requirements using sound judgement and decision-making skills. In depth experience in Quality functions in Pharma industry, focused on QMS and Compliance.
- Prior auditing experience as a lead auditor for GMP audits.
- Proven experience with regulatory inspections required.
- Demonstrated ability to lead, develop and build program infrastructure to support compliance activities and obligations to Health Authorities.
- Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements into effective global procedures/policies.
- Must possess strong leadership skills to work cross functionally and build strong business relationships with cross-functional teams and leadership.
- 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.
- 10+ years’ experience in GMP Quality Assurance including responsibilities for Quality Compliance in biotech/pharma industry, including 3+ years of people management experience.
- Prior in-depth experience in defining Quality Management System, managing audit programs, vendor management, CAPAs and Quality Agreements.
- 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 30% travel as required.