Manufacturing
How Might You Defy Imagination?
At Amgen, our shared mission—to serve patients—drives all that we do. Amgen North Carolina (ANC) is home to our newest and most advanced drug substance manufacturing plant, designed with flexibility, embedded industry 4.0 capabilities, and sustainability innovations as we progress toward Amgen’s goal of carbon neutrality by 2027.
We are seeking a Senior Manager of Manufacturing Programs to lead both the Major Deviation Investigation Team and the Process Ownership function at ANC. This leadership role has high site visibility and is pivotal in ensuring that deviations are investigated with rigor, accuracy, and compliance, while manufacturing processesremainin a state of control through effective ownership of SOPs, CAPAs, and Change Controls.
Senior Manager Manufacturing Programs - Investigations and Process Ownership
What You Will Do
As Senior Manager, you will provide leadership and operational oversight for both the Investigations and Process Ownership functions at ANC.
Investigation Leadership
Provide leadership and oversight of the Major Deviation Investigation Team, ensuring effective management of investigation timelines, technical writing, and CAPA development.
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 investigators, fostering strong technical writing, problem-solving, and critical thinking skills.
Ensureinvestigationquality and consistency, overseeing documentation for accuracy, compliance, and readiness for regulatory inspection.
Establish best practices, standardized processes, and metrics to continuously improve thedeviationinvestigation 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.
Process Ownership Leadership
Provide leadership and oversight to the Process Ownership organization, including a Manager of Process Owners and their team.
Ensure effective lifecycle management of manufacturing processes and associated documentation, including Standard Operating Procedures (SOPs), aligned with current operations and batch records.
Oversee Manufacturing CAPAs and Change Controls, ensuringtimelyprogression, high-quality execution, and compliance with site and global standards.
Ensure alignment between investigation outcomes and process ownership activities to support effective implementation of corrective and preventative actions.
Promote effective use of project management tools and structured problem-solving approaches to support execution and visibility to timelines.
Support development of technical capability within the team through coaching, mentoring, and knowledge sharing.
Cross-Functional & Strategic Leadership
Partner cross-functionallywith Manufacturing, Quality, Engineering, Process Development, Analytical Sciences, Supply Chain, and Regulatory Affairs.
Influence site-level decision-making on deviation management strategies, process improvements, and CAPA execution.
Drive initiatives to enhance efficiency, knowledge sharing, and compliance across investigation and process ownership functions.
Support regulatory inspections and audits by ensuring both investigation and process ownership systems areinspection-ready
What We Expect of You
Basic Qualifications:
High school diploma / GED and 12 years of Quality or Operations experience OR
Associates degree and 10 years of Quality or Operations experience OR
Bachelor’s degree and 8 years of Quality or Operations experience OR
Master’s degree and 6 years of Quality or Operations experience OR
Doctorate degree and 2 years of Quality or Operations experience
AND - In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
8+ years related work experience in biotech or pharmaceutical industry
Prior people leadership experience
Strong background in compliance, root cause analysis, and CAPA/change management
Experience with Quality Management Systems (e.g., Veeva,TrackWise)
Proventrack recordwith regulatory inspections and audits
Excellent organizational and communication skills
Strong interpersonal and cross-functional collaboration skills
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Salary Range
146,047.00 USD - 176,556.00 USD
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
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