Associate Director Quality Assurance

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.

Your objectives:

As the Associate Director Quality Operations, you will be measured against the following objectives:

1. Ensure sustained compliance with FDA and global regulatory standards, maintaining continuous inspection readiness.
2. Improve Right First Time, reduce deviations, and enhance operational efficiency across commercial manufacturing without compromising GMP.
3. Build and embed a proactive, accountable quality culture that supports client confidence and long-term business growth.

What you will do:

As the Associate Director Quality Operations, your duties and responsibilities will include:

• 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 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.

What you will bring:

These are the skills and experience you will need to succeed as the Associate Director Quality Operations:

• Significant leadership experience in Quality Operations within a CDMO environment, ideally with a small molecule focus.
• 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 in a scientific or engineering discipline.
• A Master of Science or relevant postgraduate qualification is desirable.

Got what it takes?

To apply for the Associate Director Quality Operations, click the ‘Apply’ button below or contact the Executive Search Consultant – Rachel Sampson – on +44 (0)203 355 7050.

Please Note:

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. Employee(s) will be required to follow any other job-related