Applied StemCell is a leading CRO and CDMO with deep scientific expertise in nonviral gene editing and iPSC product development. We offer comprehensive solutions including research products and services, process and analytical development, and cGMP clinical manufacturing for innovative allogeneic therapies aimed at transforming patient lives. After building a strong business and reputation serving the gene editing and stem cell scientific communities since 2008, we are growing our cGMP manufacturing services and maturing our Quality Systems to serve late-stage clinical and commercial cell therapy manufacturing clients and the patients who will benefit from groundbreaking new treatments and cures.
Position Overview:
We are seeking a dynamic and experienced Associate Director / Director Quality and Regulatory Affairs to lead our growing quality and regulatory functions. The successful candidate will be responsible for building and leading a strong QMS, ensuring compliance with regulatory requirements, maintaining audit readiness and interfacing with client quality and technical teams, and driving continuous improvement initiatives across all aspects of our operations.
Key Responsibilities:
Quality Management:
· Develop and implement quality management systems (QMS) in accordance with applicable regulations (e.g., FDA, EMA, ICH) and industry best practices.
· Oversee all quality control and quality assurance activities throughout the product or project lifecycle, from early clinical to commercial phase, including supplier qualification and raw material testing, in-process monitoring, and final product release.
· Collaborate with clients on quality and compliance aspects of technology transfer and new product introduction. Serve as an expert resource, internally and with clients, for business and proposal development activities.
· Establish and maintain key performance indicators (KPIs) to track and improve quality metrics for management review, such deviation and CAPA rates, environmental monitoring trending, audit performance, customer complaints, supplier quality, change control, etc.
Regulatory Affairs:
· Serve as the primary liaison to clients’ regulatory teams and ensure timely support of client regulatory CMC filings, including IND/IMPD and associated updates. Develop and maintain Drug Master Files (DMF) for banked cell products and facilities.
· Interpret and communicate regulatory requirements to internal and external stakeholders, providing guidance on compliance strategies and potential regulatory risks.
· Stay abreast of emerging regulations, guidance’s, standards, and industry trends relevant to cell and gene therapy products, and proactively integrate regulatory intelligence into business strategies.
Compliance Oversight:
· Conduct internal audits and oversee external audits from clients, regulatory agencies, and partners, ensuring adherence to cGMP, GTP, and other relevant standards.
· Collaborate with cross-functional teams to address compliance issues, CAPAs, and quality system deficiencies in a timely and effective manner.
· Champion a culture of compliance and quality excellence through training, coaching, and fostering a mindset of continuous improvement.
Risk Management:
· Lead risk assessment activities to identify and mitigate quality and regulatory risks associated with manufacturing processes, supply chain management, and product development.
· Develop risk management plans and ensure proactive risk mitigation strategies are implemented to maintain product quality and regulatory compliance.
Team Leadership/Business Management:
· Recruit, mentor, and develop a high-performing team of quality professionals, fostering a culture of accountability, collaboration, and professional growth.
· Provide strategic direction and leadership to the quality team, empowering them to achieve departmental goals and objectives.
· Develop and manage to an operating budget
Qualifications:
· Bachelor's degree in life sciences, engineering, or related field; advanced scientific degree or MBA preferred.
· Experience in quality assurance, quality control, and regulatory affairs (primarily CMC) within the biotechnology or cell and gene therapy industry, with at least 5 years in a leadership role. GCP and GLP experience is a plus.
· In-depth knowledge of global regulations governing cell and gene therapy products, including FDA and EMA requirements. Understanding of the drug development pathway and phase-appropriate CMC requirements.
· Proven track record of successful regulatory inspections and/or client audits, submissions, and interactions with regulatory agencies.
· Strong leadership and communication skills, with the ability to influence and collaborate effectively across internal and external teams.
· Strategic thinker with a demonstrated ability to develop and implement quality and regulatory strategies aligned with business objectives.
Supervised by: Chief Operating Officer
Benefits:
Competitive salary and benefits package
Opportunities for professional development and career advancement
Collaborative and highly innovative work environment at the forefront of cell and gene therapy advancements
Job Type: Full-time
Pay: $170,000.00 - $200,000.00 per year
Work Location: In person
