Director, Quality Assurance (Operations)

About the role

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.

Qualifications

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

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