Director, Quality Assurance - The Steely Group

Director, Quality Assurance

We are seeking a multi-faceted Director, Quality Assurance to serve as the cornerstone of our client's Quality function. This role requires a blend of strategic vision, tactical planning, and hands-on execution, offering the opportunity to shape the company’s Quality framework while directly contributing to day-to-day operations in our fast-paced biotech startup.

This is an ONSITE position - 5 days a week.

The Director, Quality Assurance will own all Quality-related activities within the organization, providing leadership and execution across strategic, tactical, and operational levels. This role is pivotal in ensuring compliance with cGMP and cGCP regulations as well as other regulatory standards and guidelines.

This leader will design, implement, improve, and oversee the Quality Management System (QMS), release (clinical trial) materials, manage the company’s risk register, and maintain oversight of external manufacturing, distribution, and storage partners as well as clinical sites. The ability to seamlessly shift between high-level strategy and operational execution will be critical to the company’s success in navigating clinical development and preparing for future growth.

Key Responsibilities

• Quality Leadership: Continue to define and implement a comprehensive Quality strategy that supports clinical development, CMC manufacturing, and regulatory compliance.
• Regulatory Preparedness: Serve as the company’s primary Quality liaison with regulatory agencies, ensuring readiness for FDA inspections, including pre-approval inspections, audits, and filings.
• Risk Management: Maintain and improve the company’s risk register, proactively identifying and mitigating quality risks.
• Compliance Expertise: Ensure adherence to cGMP and cGCP regulations, ICH guidelines, and FDA data integrity principles, embedding these standards into company processes.

Tactical Responsibilities

• QMS Implementation: Monitor and continuously improve the company’s Quality Management System, ensuring scalability and alignment with cGMP and cGCP requirements.
• Vendor Oversight: Manage Quality relationships with external partners, including CMOs, CDMOs, and storage facilities, through audits, Quality Agreements, coaching, and performance monitoring.
• Documentation: Review and approve cGMP and cGCP documents, including (master) batch records, validation protocols, and deviation reports.
• Inspection Readiness: Develop and execute plans to ensure inspection readiness, including training, coaching, mock audits, and gap assessments.

Execution Responsibilities

• Clinical Material Release: Conduct and document the release of clinical trial materials, ensuring compliance with regulatory and GMP standards.
• Operational Compliance: Oversee day-to-day quality operations, including deviation management, CAPA implementation, and document control, both internally and in partnership with external vendors.
• Hands-On Support: Execute quality tasks as needed, such as drafting SOPs, conducting audits, and reviewing vendor qualifications.

Cross-Functional Collaboration

• Collaborate with internal and external teams to identify and integrate Quality considerations into clinical operations, regulatory submissions, and project planning.
• Act as a Quality advocate, providing training and coaching, and fostering a culture of compliance across the organization.

Required Qualifications

• Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, pharmacy). Advanced degree preferred.
• 7+ years of experience in Quality roles within the pharmaceutical or biotech industry, including hands-on operational experience.
• Demonstrated expertise in 21 CFR Parts 210/211 and 312, FDA data integrity principles, and ICH guidelines.
• Experience designing, implementing and improving the QMS.
• Proven ability to manage the release of clinical trial materials in a cGMP environment.
• Strong experience auditing and managing external vendors, including manufacturing and storage partners.
• Successful track record leading or supporting FDA (pre-approval) inspections and audits.
• Experience with AAV gene therapy manufacturing quality oversight

Preferred Attributes:

• Experience in start-ups or small organizations, showcasing adaptability and a “roll-up-your sleeves” mentality.
• Proven ability to balance strategic vision with operational execution, managing competing priorities effectively.
• Strong communication and interpersonal skills, with the ability to influence stakeholders across all levels.
• Familiarity with managing outsourced manufacturing models and maintaining quality oversight in such settings.
• Flexible-thinker with a fit-for-purpose, solution-oriented approach.

What They Offer:

• A unique opportunity to take full ownership of the Quality function, combining strategic leadership with day-to-day execution.
• Direct involvement in advancing a clinical-phase product, thereby shaping the company’s future.
• A collaborative and entrepreneurial environment where your contributions will have a direct impact on patient health and regulatory approaches.