Job Description

Job Description

Manager, QA Compliance & Validation – Bend, OR

Are you a Quality Assurance professional ready to lead with purpose and precision? This opportunity offers the chance to manage compliance and validation initiatives within a dynamic pharmaceutical and biotech manufacturing environment — ensuring excellence across regulated systems and operations.

About the Role

As Manager, QA Compliance & Validation , you’ll lead a dedicated quality team, oversee compliance programs, and ensure that processes align with regulatory expectations and business objectives. You’ll serve as a key subject matter expert during audits and inspections, supporting continuous improvement and operational excellence.

Key Responsibilities

• Lead internal and external audits, inspections, and compliance evaluations as the QA subject matter expert.
• Maintain current knowledge of applicable cGMP regulations and train personnel accordingly.
• Oversee compliance of pharmaceutical development and cGMP manufacturing activities.
• Identify and implement CAPA measures, ensuring effectiveness and timely completion.
• Develop workflows, metrics, and systems to monitor compliance and performance.
• Manage and enhance Quality Management Systems and documentation processes.
• Supervise QA staff involved in lifecycle management of quality documents.
• Review and approve regulatory documents and ensure readiness for inspections.
• Collaborate cross-functionally to foster a culture of quality and continuous improvement.

Qualifications

• Bachelor’s degree or equivalent experience required.
• Significant experience in the pharmaceutical or biotechnology industry.
• Strong background in regulatory compliance and quality management.
• Prior leadership or management experience required.
• GMP experience preferred.
• Excellent leadership, communication, and organizational skills.
• Ability to work independently and collaboratively in a fast-paced, regulated environment.

What’s Offered

• Competitive salary and comprehensive benefits.
• Inclusive, ethical, and innovation-driven work culture.
• Opportunities for professional growth and global collaboration.

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