Senior Manager Manufacturing Programs - Investigations and Process Ownership
Company: Amgen
Location: Holly Springs
Posted on: March 29, 2026
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Job Description:
How Might You Defy Imagination? At Amgen, our shared missionto
serve patientsdrives 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
Amgens 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 ANCs 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 Bachelors degree and 8 years of Quality or
Operations experience OR Masters 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 What you
can expect of us 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, well 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. Apply now and make a lasting impact with the
Amgen team. careers.amgen.com 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.
Keywords: Amgen, Chapel Hill , Senior Manager Manufacturing Programs - Investigations and Process Ownership, Healthcare , Holly Springs, North Carolina
