About the Company - 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 developing and improving Zevra’s QMS and supporting operational processes. This position is further responsible for assuring that compliance with the established 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, is maintained. Key attributes of the incumbent include creativity and enthusiasm for building lasting organizational structure and systems suitable capable of growing with the organization. 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 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 -
- Overall responsibility for the development, improvement, deployment and maintenance of harmonized quality systems encompassing development and commercial programs,
- Responsible for ensuring quality systems and processes are harmonized with relevant corporate policies and regulatory requirements, and are deployed consistently,
- 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, assures that the serialization system for commercial distribution remains compliant,
- Responsible for the oversight of compliant administration of exception, investigation, CAPA, product complaints management systems pertaining to Zevra and vendor and operations,
- Prepares content and conducts periodic Quality Management Reviews and supports preparation of annual product reviews,
- Oversees Quality Vendor Management,
- Assures that quality surveillance activities including internal and external (vendor) audits, self-inspections and regulatory inspection readiness meet company and applicable regulatory standards. This includes, but is not limited to, establishing annual audit plans, audit planning and execution, reporting and coordination with external contractors,
- Ensure departmental training programs are appropriately established and meet applicable regulatory and organizational requirements,
- Organizes and provides periodic GxP training and ensure that training requirements are consistently met, as required,
- In collaboration with Head of Quality and other department heads, prepare, review, approve, and implement SOPs as required,
- Oversee biennial controlled document review,
- Oversee the management of relevant electronic systems for quality system support (e.g., for controlled documents, training management, change control),
- Lead 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
- Establish and lead continuous improvement initiatives to optimize Zevra’s quality and compliance position.
Required 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
- A 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,
- 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
- Experienced leader in Quality Systems and Quality Assurance.
