Associate Director/Director Quality Assurance

Key Responsibilities

• Provide direct oversight of daily QA operations, including product and material release, deviations, investigations, CAPAs, complaints, change control, internal audits, and inspection readiness activities.
• Ensure quality operations are calibrated correctly across our dual clinical and commercial scope.
• Manage material and supplier quality activities, including vendor qualification, incoming material review, and supplier change notifications, ensuring supply chain inputs do not introduce uncontrolled compliance risk into manufacturing operations.
• Represent Quality in client program reviews, project management meetings, and executive discussions.

Quality Systems Ownership

• Own the design, implementation, maintenance, and continuous improvement of our core quality management systems, including document control, change control, deviation and investigation management, CAPA, training, internal audit, and stability program administration.
• Ensure quality systems are not only compliant but genuinely usable for front-line manufacturing and QC teams.
• Evaluate and implement eQMS and LIMS platforms and upgrades; serve as the quality systems owner for validation, rollout, training, and ongoing administration of electronic quality and laboratory data management systems.
• Establish and maintain quality metrics and leading indicators that give site leadership an accurate, real-time view of operational compliance health.

Investigations & CAPA Leadership

• Lead and own the site’s deviation and investigation program: ensure deviations are captured completely and promptly, investigations are conducted with appropriate depth and technical rigor, and root cause conclusions are supported by evidence.
• Drive OOS/OOT investigations from QA oversight perspective: ensure QC’s laboratory investigation is methodologically sound and Phase I conclusions are technically defensible before proceeding to Phase II.

Audit & Inspection Leadership

• Lead as the primary quality representative and front-room lead for all regulatory and client audits and inspections, including FDA, EU, and other applicable regulatory bodies, as well as sponsor quality audits across clinical and commercial programs.
• Develop and maintain sufficient operational subject matter expertise across key site functions — including Manufacturing, Facilities, Utilities, Validation, QC, and Supply Chain.
• Conduct and oversee a robust internal audit program that proactively identifies compliance gaps, system failures, and execution drift before external parties do; translate internal audit findings into prioritized remediation with clear ownership, timelines, and effectiveness verification.

Regulatory Intelligence & Adaptability

• Monitor evolving regulatory guidance from FDA, EMA, ICH, and other relevant bodies; translate new guidance into practical implications for quality systems and manufacturing controls.
• Evaluate quality and compliance implications when we enter new program types, regulatory jurisdictions, or manufacturing modalities.

Qualifications

• BS or MS in a scientific discipline such as Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or related field.
• Typically, 8–12+ years of progressive GMP quality experience in QA, QC, or Quality Systems within pharma, biotech, or CDMO environments.
• Prior leadership experience overseeing quality operations, quality systems, or major quality workstreams.
• Demonstrated ability to work effectively in a small, hands-on, fast-moving organization.
• Strong communication and collaboration skills across technical and non-technical functions.
• Experience with eQMS/LIMS and continuous improvement initiatives is preferred.

Compensation

This role offers a competitive base salary in the range $180-230K, plus performance-based bonus. Final compensation will be determined based on experience, qualifications, and overall fit.

About Mix Talent

Mix Talent is a specialized recruiting partner focused on building high-performing teams across the life sciences industry. We partner closely with innovative companies to identify talent that drives meaningful impact.