Scope:
The Director of Quality has a critical role within Zevra that will provide strategic and technical leadership for the optimization and administration of Zevra’s Quality Management System (QMS). The position is responsible for maintaining compliance with the QMS and GxP (GMP, GCP, GDP and GLP) requirements in accordance with US, European and other country-specific regulations, both internally and in collaboration with our vendors and partners. This position is responsible for establishing and maintaining overall quality surveillance (audits and inspection readiness), Quality Operations (batch disposition), and Quality Systems (deviation, CAPA, change control, document control product complaints, and training).
The qualified candidate must have experience building and maintaining sustainable and trusting cross-functional relationships with key strategic internal and external stakeholders. The incumbent must rapidly earn a strong reputation supporting quality programs from preclinical through commercialization stages. This position requires close cross-functional teamwork, an ability to understand and communicate risk, and a desire to coach and develop cross-functional staff.
Responsibilities:
- Performs Quality review and approval of IMP and Commercial Product manufacturing documentation (e.g., master batch records, validation protocols and reports) and provides disposition of drug substance, drug product,clinical trial materials, and disposition of commercial finished goods,
- In coordination with the Manufacturing team, maintains serialization system for commercial distribution,
- Responsible for the compliant administration and oversight of exception, investigation, CAPA, product complaints management systems pertaining to Zevra and vendor operations,
- Prepares content and conducts annual product reviews and periodic Quality Management Reviews,
- Oversees Quality Vendor Management processes and procedures,
- Administers and manages quality surveillance activities including internal and external (vendor) audits, self-inspections and regulatory inspection readiness. This includes, but is not limited to, establishing annual audit plans, audit planning and execution, reporting and coordination with external contractors,
- Serves as person-in-plant during third party manufacturing/packaging operations and campaigns,
- Ensures GxP training programs are appropriately established and meet applicable regulatory and organizational requirements,
- Organizes and provides periodic GxP and SOP training, as required,
- In collaboration with Head of Quality and other department heads, prepare, review, approve, and implement SOPs as required,
- Oversees biennial controlled document review,
- Manages relevant electronic systems for quality system support (e.g., for controlled documents, training management, change control),
- Leads Quality Review Boards, providing technical expertise for product quality decisions,
- Leads manufacturing investigations, in collaboration with the Manufacturing Team, ensuring appropriate corrective and preventive actions are taken as required, and
- Establishes and leads continuous improvement initiatives to optimize Zevra’s quality and compliance position.
Competencies/Skills:
- Proven ability to thrive working in a fast-paced, innovative remote environment while remaining flexible, proactive, resourceful, hands-on and efficient,
- In-depth knowledge of GxP, 21CFR, EU GMP, ICH, ISO, QSR, EUGDP and other applicable domestic and international regulations, standards, Directives and Guidance.
- Exhibits commitment to collaborative leadership, execution, teamwork and the maintenance of a professional culture based on trust and mutual respect,
- Excellent interpersonal, reading, writing, negotiation, communication, conflict resolution and public presentation skills, along with exceptional organizational and problem-solving skills,
- Proven ability to analyze scientific issues and develop relevant and realistic recommendations and plans and take responsibility for implementing,
- Proven ability to identify and manage contract/vendor resources to support Quality-related goals,
- Successful track record of working in a matrixed (virtual) organization and building strong relationships with other functions and contractors/vendors,
- Experience in a virtual manufacturing environment,
- Ability to work under pressure, meet deadlines and contribute to achieving high level activities as well as tactical and administrative tasks, and
- Proven leadership in Quality Assurance, Quality Systems and/or Quality Operations.
Education and Experience:
- 10+ years of pharmaceutical/biotech industry experience in in the development and administration of quality systems supporting pre-clinical, clinical and commercial programs,
- 5+ years of Quality leadership experience with a successful track record in vendor oversight and managing relationship with external stakeholders as well as internal QA systems in a virtual environment,
- 5+ years’ experience in the establishing and administering of GCP-, GLP- and GDP-compliant systems is a plus,
- Bachelors or Advanced degree in a scientific or related discipline,
- Detailed understanding of worldwide requirements of cGMP and quality systems for clinical and commercial products,
- Proven leadership in support of regulatory health authorities inspections,
- Proven record of vendor management and administration of audit programs for third-party suppliers/vendors,
- Experience with new product launch and implementation of serialization systems and commercial product complaint management processes,
- Strong team player that has a customer service approach and is solution oriented,
- Ability to travel both domestically and internationally as needed (~15-20%),
- The candidate will need to embrace and drive Zevra’s mission and core values,
- Ability to effectively communicate with inspiration, lead and influence individuals from multiple functional departments at all levels of the organization,
- Strong organizational and time management skills to balance working on multiple projects and initiatives in parallel,
- A proven self-starter capable of high performance with limited direction and oversight,
- Excellent people leader with strong mentorship skills. Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a changing environment, and
- Excellent written communication and oral presentation skills.
