Associate Director Quality Operations

Do you want to lead Quality Operations for a commercial small molecule manufacturing site?

Are you ready to shape a culture where compliance and performance go hand in hand?

Do you enjoy partnering with clients to deliver high-quality medicines right first time?

Fraser Dove International is partnering exclusively with a growing small molecule CDMO. Operating in Oregon, they are committed to delivering safe, compliant, and efficient commercial manufacturing for global pharmaceutical partners.

Our client is seeking a strategic and hands‑on leader to oversee site‑based Quality Operations, driving compliance, performance, and cultural change across commercial manufacturing.

Discover more about our Associate Director Quality Operations opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

• Ensure sustained compliance with United States Food and Drug Administration (FDA) and global regulatory standards, maintaining continuous inspection readiness.
• Improve Right First Time (RFT), reduce deviations, and enhance operational efficiency across commercial manufacturing without compromising Good Manufacturing Practice (GMP).
• Build and embed a proactive, accountable quality culture that supports client confidence and long‑term business growth.

• Lead and develop a team of approximately 10 quality professionals across batch release, deviation management, change control, and on‑floor quality oversight.
• Provide quality leadership for commercial manufacturing, ensuring robust oversight of shop floor activities and timely product disposition.
• Act as the primary quality contact for client interactions, audits, and regulatory inspections.
• Drive continuous improvement initiatives to strengthen the Quality Management System (QMS) and enhance operational performance.
• Partner closely with Manufacturing, Technical Operations, and Supply Chain to resolve issues, mitigate risk, and improve process robustness.
• Champion inspection readiness activities, hosting regulatory authority inspections and client audits with confidence and clarity.
• Lead cultural change initiatives that promote ownership, transparency, and data‑driven decision making across the site.

• Significant leadership experience in Quality Operations within a small molecule CDMO or pharmaceutical manufacturing environment.
• Strong knowledge of FDA and global regulatory requirements within a commercial GMP setting.
• Demonstrated success improving quality performance metrics such as RFT, deviation reduction, and cycle time improvement.
• Proven ability to lead and develop high‑performing teams in a regulated manufacturing environment.
• Experience managing client relationships and acting as a trusted quality partner during audits and lifecycle activities.
• Bachelor of Science (BSc) in a scientific or engineering discipline.
• A Master of Science (MSc) or relevant postgraduate qualification is desirable.

To apply for the Associate Director Quality Operations, click the ‘Apply’ button below or contact the Executive Search Consultant – [Rachel Sampson] – on

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position.