Director, Quality Assurance (Operations)

Zevra Therapeutics•Boston, MA

2d•Remote

About The Position

The Director of Quality Operations has a critical role within Zevra that will provide technical leadership for the administration of Zevra’s Quality Management System (QMS). The position is responsible for improving Zevra’s QMS and supporting operational processes. This position is further responsible for assuring that all development and commercial operations carried out by Zevra and its contractors consistently comply with Zevra standards and applicable regulations. Key attributes of the incumbent include enthusiasm for building lasting organizational 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.

Requirements

10+ years of progressive experience in pharmaceutical/biotech industry with expertise in establishing effective and efficient systems and processes supporting pre-clinical, clinical and commercial programs,
7+ 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,
7+ years’ experience in the establishing and administering of GCP-, GLP- and GDP compliant systems,
Bachelors or Advanced degree in a scientific or related discipline,
Understanding of worldwide requirements of GxP compliance and quality systems for clinical and commercial products,
Leadership role in the management of regulatory/health authorities inspections,
Strong team player that has a customer service approach and is solution oriented,
Ability to travel both domestically and internationally as needed, likely to be ~10 15%,
The candidate will need to embrace 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,
Excellent written communication and oral presentation 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,
Experienced leader in Quality Assurance.

Nice To Haves

Experience with new product launch and implementation of serialization systems and commercial product complaint processes is a plus

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, assures that the serialization system for commercial distribution remains compliant,
Responsible for the execution of compliant administration of exception, investigation, CAPA, product complaints management systems pertaining to Zevra and vendor and operations,
Supports preparation of content and facilitates conduct of periodic Quality Management Reviews and supports preparation of annual product reviews,
Engages in the day-to-day efforts of Quality Vendor Management,
Conducts and/or facilitates internal and external (vendor) audits, self-inspections and regulatory inspection readiness meet company and applicable regulatory standards. This includes, but is not limited to, audit planning and execution, reporting and coordination with external contractors,
Supports 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,
Responsible for Quality Review Boards, providing technical expertise for product quality decisions,
Responsible for manufacturing investigations, in collaboration with the Manufacturing Team, ensuring appropriate corrective and preventive actions are taken as required,
Support continuous improvement initiatives to optimize Zevra’s quality and compliance position,
Cross-train and serve as back-up for Quality Systems, as assigned.