Senior Manager Manufacturing - Deviation Investigations

Senior Manager Manufacturing - Deviation Investigations

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Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single-use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager Manufacturing Deviation Investigations

What You Will Do

Lets do this. Lets change the world. In this vital role, you will provide strategic and operational leadership for the Investigations function  will oversee a team of Level 5 Investigators and ensure investigations meet regulatory and quality expectations while driving a culture of compliance and continuous improvement.

• Lead the Major Investigation Writing Team responsible for high-complexity deviation investigations within ANC's Drug Substance Flex Batch Manufacturing operations.
• Provide direct management, coaching, and development to Level 5 investigators, fostering strong technical writing, problem-solving, and critical thinking skills.
• Ensure investigation quality and consistency, overseeing documentation for accuracy, compliance, and readiness for regulatory inspection.
• Establish best practices, standardized processes, and metrics to continuously improve the deviation investigation system.
• Serve as the point of contact for escalation of critical investigations and communicate investigation outcomes to site and global leadership.
• Present investigations and findings to regulatory inspectors, internal auditors, and senior leadership.
• Partner cross-functionally with Manufacturing, Quality, Engineering, Process Development, Analytical Sciences, Supply Chain, and Regulatory Affairs.
• Influence site-wide decision-making on deviation management strategies and corrective/preventative actions (CAPAs).
• Drive strategic projects to enhance efficiency, knowledge sharing, and compliance in deviation investigation processes.

• High school diploma / GED & 12 years Quality and/or Manufacturing experience OR
• Associate's degree & 10 years of Quality and/or Manufacturing experience OR
• Bachelor's degree & 8 years of Quality and/or Manufacturing experience OR
• Master's degree & 6 years of Quality and/or Manufacturing experience OR
• Doctorate degree & 2 years of Quality and/or Manufacturing experience

• 8+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Prior people leadership experience, managing and developing a team of investigators or equivalent technical staff
• Strong background in compliance, root cause…