Senior Director of Operational Quality Assurance

We are seeking a highly skilled and experienced Senior Director of Operational Quality Assurance to join an innovative CDMO located in the Midwest. This permanent position is critical for ensuring compliance with established Good Manufacturing Practices (GMP) while overseeing quality assurance in drug product manufacturing.

Responsibilities

• Oversee and lead operational QA activities in drug product manufacturing.
• Ensure strict adherence to GMP regulations and company standards.
• Drive quality improvement initiatives and maintain audit readiness.
• Collaborate with cross-functional teams to enhance processes and compliance.

Qualifications

• Extensive experience in drug product manufacturing is required.

Key Skills

• Quality Assurance: Expertise in implementing and maintaining QA systems in a regulated environment.
• Good Manufacturing Practice: In-depth knowledge of GMP regulations and their application within the biotech sector.
• Drug Product Manufacturing: Proven experience managing quality assurance processes specific to drug production.
• Leadership: Ability to guide teams effectively while ensuring compliance and operational excellence.

If you are passionate about quality assurance within biotech and possess the requisite skills, we encourage you to apply for this pivotal leadership role based in North Dakota.