Position Summary

The Associate Director, Quality Engineering is responsible for providing leadership and oversight of Quality Engineering functions supporting GMP manufacturing operations. This role ensures that facilities, utilities, equipment, and processes are qualified and validated in compliance with FDA regulations and company policies. The Associate Director will collaborate cross-functionally with Manufacturing, Facilities, Engineering, Validation, and Quality Assurance teams to maintain a state of control, enable continuous improvement, and ensure readiness for regulatory inspections.

Essential Functions (ES) and Responsibilities

• Lead and manage the Quality Engineering team supporting GMP facility and manufacturing operations.
• Serve as SME for validation, equipment qualification, critical utilities, and process validation.
• Set strategy and priorities for Quality Engineering activities to support current operations and new product introductions.
• Ensure validation and qualification programs (facilities, utilities, equipment, cleaning, process, and computerized systems) meet regulatory expectations and company standards.
• Oversee quality review/approval of validation protocols, reports, and change controls.
• Partner with Quality Systems to manage deviations, investigations, CAPAs, and change controls related to engineering and validation activities.
• Provide guidance during regulatory inspections.
• Collaborate with Facilities/Engineering on maintenance and calibration programs for GMP-critical equipment and systems.
• Support technology transfers, scale-up, and process validation activities in alignment with lifecycle approaches (e.g., CPV, Stage 1–3 validation).
• Drive risk-based decision-making and ensure effective quality risk management practices are in place.
• Champion continuous improvement initiatives to optimize compliance, efficiency, and reliability.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education and Experience Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• 10+ years of experience in Quality, Validation, or Engineering roles in biotech or pharmaceutical GMP manufacturing.
• Strong knowledge of FDA and ICH guidance (e.g., ICH Q8–Q10).
• Deep expertise in validation lifecycle, equipment/facility qualification, utilities, and process validation.
• Experience supporting regulatory inspections with strong knowledge of current industry expectations.
• Familiarity with computerized systems validation and data integrity principles (21 CFR Part 11).
• Demonstrated leadership and team management experience.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.