Director, Quality Assurance
* Location: Raleigh-Durham, North Carolina
* Working Situation: Onsite
* Level: Director
Our client, a dynamic and growing clinical manufacturing brand, is working to move CAR-T programs to commercial phase. We are seeking a highly focused QA Director who has a strong background in cell and gene therapy, biologics products and leadership. The Director will report into the Site Head and other executives with the ability to form lasting connections and deliver novel drugs to patients.
The Director, Quality Assurance will understand fostering a quality focused approach with a deep understanding of Manufacturing, QA/QC, and Supply Chain functions. The Director will be overseeing the manufacturing, testing and validation activities. This onsite role requires strong leadership to uphold quality standards and compliance, ensuring seamless integration with global quality processes.
The Director, Quality Assurance will be responsible for:
* Lead and nurture the Quality Assurance team, aligning with the company's quality vision and goals in coordination with the VP of QA
* Oversee quality and compliance systems at the manufacturing facility, ensuring alignment with global standards
* Review and oversee validation efforts during facility startup phases
* Establish a robust QA compliance framework for GMP adherence
* Collaborate with the broader quality organization to enhance quality processes continually
* Manage team responsibilities to achieve functional and facility objectives
* Implement quality metrics and facilitate management review processes
* Support external visits and regulatory inspections
* Develop and manage the Site Master File
* Provide strategic and tactical quality decisions in collaboration with Operations
* Assist in due diligence audits and partner qualification
* Set clear quality objectives and drive risk analysis and mitigation strategies
* Provide leadership, guidance, and direction to staff in line with cGxP standards
* Support the overall growth of the Quality Team and organization
* Exemplify the company's cultural values and align daily actions with departmental goals and company culture
The Director, Quality Assurance has the following qualifications:
* Bachelor's or Advanced degree in a scientific discipline or related field
* 10-15 years of experience in pharmaceutical/biotech industry, including drug substance/drug product manufacture, development, and/or quality
* 6-8 years of experience in Quality management and team leadership
* Experience interacting with regulatory health authorities
* Knowledge of global regulations and standards
* Collaborative team player with a customer service mindset
* Ability to work effectively both independently and within teams
* Proficient in managing vendors and external partners
* Must reside locally in the RTP area and be available for daily onsite work
Company Benefits:
* Unlimited PTO
* 401k with company matching
* Tuition Reimbursement
