Vice President, Quality Operations
The Vice President of Quality Operations will serve as the senior advisor and responsible person on all quality issues, while building and leading a first-rate quality capability for StrideBio for investigational and commercial novel AAV capsid manufacturing utilizing the Strive™ platform.
The Vice President of Quality Operations will be responsible for implementing quality assurance and quality control systems and processes for cell and gene therapy products being manufactured by StrideBio. This position will also be responsible for all Quality Control responsibilities regarding testing and release of these products as well as being responsible for the quality levels of raw materials and components sourced from external manufacturers.
This role will function as a full partner with the other Technical Operation groups, along with the Platform development and Preclinical development groups, working together to improve quality processes and manufacturing ability of products, and serving as “early warning radar” on quality related manufacturing problems.
The Vice President of Quality Operations will be responsible for developing, maintaining and evolving quality systems, quality manuals, policies, procedures, protocols, operating methods and records to ensure product quality and compliance with cGMP regulations and applicable product approval as well as setting, monitoring and maintaining the Quality standards for the U.S. manufacturing site for both investigational and commercial products. The position will be the lead contributor for input into the Quality program for the Corporation.
The position will report into the COO and will be based out of the StrideBio headquarters located in Research Triangle Park in North Carolina. The position may require travel 20-25% of the time.
- Implements a Quality Management System and the Quality organization needed to execute it.
- Applies best practices with respect to aseptic biologic manufacturing.
- Assess and provide recommendation to management on Quality systems and equipment to be purchased and implemented.
- Will serve as the key liaison on Quality matters with all functional departments.
- Oversees all GMP quality activities and ensures they are governed through key performance metrics and a quality review system.
- Develops, in conjunction with all stakeholder groups, a Quality Manual and Master Quality Plan for the manufacturing site.
- Responsible for articulating, leading, and implementing the Quality Manual and Master Quality Plan.
- Provide leadership on quality policies and practices, while working in collaboration with multiple department functions at StrideBio.
- Assure that finished products conform to government and company standards and regulatory approvals for clinical and commercial products.
- Responsible for championing a partnership/customer focus approach in the organization so that all functions view the quality organization as a proactive collaborator and partner to facilitate achieving goals.
- Provide the leadership to assure the preparation of appropriate documentation for filing with regulatory bodies.
- Develop a quality organization and staff to implement and maintain compliance with cGMP and all health agency requirements.
- Provide the overall leadership in respect to recruiting, training, developing and supervising staff to accomplish quality compliance and goals.
- Responsible for establishing department budgets and managing expenditures appropriately.
KNOWLEDGE AND SKILLS:
- A strong, seasoned biopharmaceutical quality professional with a minimum of 15 years relevant experience.
- Experience working with cell and gene therapy products a strong plus.
- Minimum of a Bachelor’s degree in a related health science. An advanced scientific degree is highly desirable.
- A keen knowledge and experience base working with research and development and manufacturing groups on quality issues is essential.
- A strong experience base on global GMP, QA and QC issues pertaining to biologics is required.
- Expertise in aseptic manufacturing is required.
- Knowledge of FDA, EU and International regulations, EU, and US compendial requirements and industry best practices regarding documentation systems, design control, change control, product specifications and cGMP’s.
- Experience in managing budget.
- Understanding of AAV viral vector manufacturing would be a plus.
- Experience in leading cross functional teams, working as a member of such teams, and providing functional resources under supervision to such teams.
- Demonstrated, hands-on approach to building a successful quality organization in a startup environment.
- Strong leader who can achieve agreements through an educational collaborative approach and able to be firm and decisive on quality and compliance issues.
- Excellent communication, leadership, collaboration, and interpersonal skills with an ability to serve as a mentor to junior staff.
- Flexible and able to adapt to company growth and evolving responsibilities
StrideBio is a product-driven, fully integrated gene therapy company focused on creating and developing innovative genetic medicines with life-changing or curative potential for patients with devastating conditions, including monogenic rare disease and beyond.
We leverage our proprietary structure-inspired adeno-associated virus (AAV) vector engineering platform (STRIVE™) to create unique and differentiated vectors that improve upon naturally occurring AAV serotypes to overcome current limitations of first-generation gene therapies. Combined with our genetic construct design expertise and in-house manufacturing capabilities, StrideBio is positioned to generate best-in-class genetic medicines that allow more patients to benefit with maximum efficiency, leading to improved treatment outcomes.
Our team is comprised of accomplished leaders and talented, passionate colleagues with a desire to translate innovative science into treatments. Together with our collaborators we are making rapid progress on our mission to bring novel medicines to patients who desperately need them. StrideBio’s offices, labs and manufacturing facility are located in the heart of Research Triangle Park, NC, within 10 miles of downtown Durham and Raleigh-Durham International Airport.
COMPENSATION & BENEFITS:
We offer a competitive salary and excellent benefits package including:
- Stock Options and Bonus
- Medical, Dental, and Vision health insurance
- Matching 401k plans (both Pre-tax and Roth Post-tax)
- Life/AD&D, Long-term and Short-term disability
- Employee Assistance Program
- Voluntary: Supplemental Life, Critical Illness, Group Accident, Hospital Indemnity, Identity Theft Protection
Additionally, we provide the following perks:
- Relocation Services
- Retail Member Discount Programs
- Complimentary onsite gym membership
- Fully stocked kitchen
- Socials, happy hours, and other events throughout the year (currently “virtual”)