Director, Quality Engineering

Role Overview

• Lead the development and execution of global GMP quality engineering strategies aligned with regulatory expectations and business objectives.
• Serve as the organizational lead for Quality Risk Management (QRM), establishing risk-based approaches to identify, evaluate, and mitigate quality and compliance risks.
• Drive continuous improvement (CI) initiatives using tools such as Lean, Six Sigma and root cause analysis to improve product quality, process robustness, and operational efficiency.
• Oversee the enhancement and maintenance of core quality systems (e.g., CAPA, deviation management, change control, batch release, investigations) to ensure effectiveness and inspection readiness.
• Strengthen data integrity controls and drive global initiatives to ensure compliance with ALCOA+ principles.
• Lead quality oversight for manufacturing activities, tech transfer, scale-up, validation, and commercial production to ensure end-to-end GMP compliance.
• Provide strategic direction during regulatory inspections (FDA, EMA, MHRA, PMDA) and internal audits; ensure timely resolution of observations and sustainable remediation.
• Collaborate cross-functionally with Manufacturing, QC, Regulatory Affairs, Supply Chain, and Commercial teams to embed quality into operational decision-making and strategic planning.
• Develop and implement risk-based monitoring and metrics to proactively assess performance and compliance trends.
• Guide quality input for new product introductions (NPI), clinical and commercial launches, and global supply chain strategies to ensure product availability and regulatory alignment.
• Lead and mentor a global team of quality engineers and specialists; build capabilities through training, coaching, and talent development.
• Represent the Quality function in strategic business forums and quality governance meetings; act as a key quality liaison to executive leadership and health authorities.
• Foster a culture of quality excellence, ownership, and continuous learning throughout the organization.

Requirements

• Bachelor’s degree in a science discipline and at least 12 years of experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) with a minimum of 8 years supervisory/leadership experience
• Deep technical expertise in GMP-compliant manufacturing environments
• Thorough understanding of evolving global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA)
• Experience leading quality transformation initiatives that deliver both regulatory confidence and operational excellence
• Candidate must have strong background in Drug Substance and/or Drug Product Manufacturing, experience with small molecules and solid oral dose development is a plus
• Strong organizational and interpersonal skills, with a keen attention to detail
• Must be able to communicate efficiently with Contract Manufacturing Organizations and with internal cross-functional teams
• Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment
• Ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner
• Must possess excellent communication skills, both verbal and written. and ability to write concise SOP’s
• Strong self-motivation as well as the ability to work independently, and in a team environment with minimum supervision
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Ability to identify situations that will require management intervention for resolution

Benefits

• discretionary annual target bonus
• stock options
• ESPP
• 401k match
• top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• winter company shutdown