Associate Director, Quality Assurance

Associate Director, Quality Assurance

The Associate Director, Quality Assurance provides leadership and oversight of Quality Operations supporting both Clinical and Commercial manufacturing activities at the Sellersville site. The role ensures compliance with cGMP requirements, data integrity standards, computer system validation requirements, and client and regulatory expectations.

Lead Quality Operations, Clinical Operations, Commercial Operations, Data Auditing and QA IT support.

Provide oversight of deviations, CAPAs and change controls.

Review and approve GMP documentation including batch records, SOPs, protocols and validation documents.

Serve as primary quality contact for clients and support project meetings.

Develop and monitor operational quality metrics and KPIs.

Support audits and inspections by customers and regulatory agencies.

Oversee staffing, capacity planning, cross-training and talent development.

Manage supplier quality activities, annual product reviews and departmental budgets.

Ensure compliance with 21 CFR Part 11, Annex 11 and GAMP 5 requirements.

Act as designee for Quality leadership as needed.

Internal: Technical Operations, Supply Chain, Quality Control, Quality Systems, Engineering, Facilities, R&D, Project Management and Business Units.

External: Commercial and Clinical Clients, FDA, EU and other regulatory agencies.

Bachelor's degree in a scientific discipline preferred.

Minimum 10 years of progressive Quality experience in a regulated cGMP environment.

Minimum 3 years of people leadership experience.

Experience in oral solid dosage manufacturing required.

CDMO experience preferred.

Other duties as deemed necessary.

Knowledge & Skills

Strong leadership, communication and interpersonal skills.

Expertise in QA, QC, Compliance and Quality Systems.

Experience with SAP, TrackWise, Ensur and other GxP systems.

Knowledge of regulatory requirements and inspection readiness.

Strong attention to detail and problem-solving skills.