Associate Director Quality

Job Summary

The Associate Director Quality is responsible for ensuring that Quality performance, compliance, and operational excellence are embedded and maintained across all strategic initiatives, GMP operations, and support functions at the Rockville site. This role provides leadership for Quality Operations Oversight, On‑the‑Floor Quality, and client‑facing Quality programs supporting the CDMO‑Rockville portfolio. The Associate Director leads, develops, and mentors Quality staff while providing strategic direction to maintain compliance with regulatory requirements in support of existing and new cell‑based gene therapy manufacturing.

Key Responsibilities:

Quality Leadership & Strategic Oversight

• Serve as a strong, accountable leader who motivates, mentors, and develops the Quality team; sets clear expectations and drives ownership, performance, and continuous improvement.
• Apply deep process knowledge and technical acumen—gene therapy preferred, biologics acceptable—to drive effective decision‑making, even in areas with limited historical precedent.
• Represent Quality as an FDA‑facing subject matter expert and provide expertise to support preparation for regulatory inspections and client audits.
• Promote a risk‑based, phase‑appropriate, and agile quality culture; demonstrate balanced judgment across Quality, operational timelines, and client needs.

Operational Quality Oversight

• Ensure Quality deliverables for batch record review, lot disposition, and product release meet internal and external expectations and are executed in a timely, compliant, and client‑focused manner.
• Oversee the review and approval of GMP records including batch production records, QC test reports, EM data, cleaning records, equipment and facility records, assay qualifications, stability protocols, and related documentation.
• Manage execution of on‑the‑floor Quality operations, including walkthroughs of manufacturing, QC labs, storage, and material receiving areas to ensure GMP compliance.
• Provide technical expertise during investigations; support data gathering, root‑cause analysis, and development of corrective and preventive actions (CAPA).

Client & Project Support

• Monitor Quality support activities for client programs and ensure issues are escalated appropriately to maintain on‑time project delivery.
• Partner with Manufacturing, Technical Operations, and cross‑functional stakeholders to resolve issues, identify root causes, and implement effective CAPA.
• Act as a role model for effective problem‑solving and triage by demonstrating sound judgment, balanced risk assessment, and strong communication.

Quality Systems & Documentation

• Oversee the revision, issuance, and tracking of controlled documents supporting bulk and sterile fill operations.
• Perform and/or approve Quality Control data review, audit trail review, and other compliance checks.
• Support cross‑training and participate in other Quality functions including Quality Systems, Training, Document Control, and Supplier Quality.
• Contribute to internal and vendor audits; identify deficiencies and ensure timely closure of observations.
• Drive continuous improvement initiatives that support self‑detecting, self‑correcting systems and operational excellence.

Leadership, Communication & Issue Resolution

• Notify senior management of critical issues with potential impact to manufacturing timelines, offering feasible solutions and risk‑mitigation strategies.
• Actively participate in hiring, onboarding, and developing new team members.
• Ensure effective communication at all levels of the organization and with external clients.

Job Qualifications

• BS/BA required; MS in a scientific or technical discipline preferred.
• Minimum 8 years of Quality leadership experience in biologics, pharmaceuticals, or cell/gene therapy.
• Experience with CDMO operations and/or gene‑modified or cell‑based therapies required.
• Demonstrated experience reviewing QC test results and GMP batch records for clinical and commercial manufacturing.
• Strong working knowledge of FDA, EMA, ICH regulations and industry best practices.
• Experience with TrackWise or similar electronic Quality management systems preferred.
• Excellent interpersonal, negotiation, and conflict‑resolution skills; able to influence across levels and functions.
• Exceptional written and verbal communication skills.
• Strong organizational capability to manage complex processes and competing priorities.
• Proven ability to lead investigations, risk assessments, and CAPA programs.
• Internal or external auditor experience.
• Hands‑on, detail‑oriented, proactive, and able to make informed decisions in ambiguous situations.

Compensation Data

The pay rate for this role is $156,000 - $176,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.