Quality Compliance Senior Manager
Quality Compliance Senior Manager
United States - Remote Apply NowJoin 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
Quality Compliance Senior Manager, GMP/GDP Inspections Global Process Owner (GPO)
What you will do
Let’s do this. Let’s change the world. As part of the GxP Quality Management System (QMS) architecture, the GMP/GDP Inspections Global Process Owner (GPO) leads the design, governance, and continuous advancement of the end‑to‑end GMP/GDP inspection lifecycle, from inspection readiness and preparation through inspection execution, outcome management, and regulatory commitment tracking. This role is a critical leader within the Inspection Lifecycle Management organization, ensuring consistent, compliant, and inspection‑ready practices across the global network for Health Authority, Notified Body and Business Partner inspections of Amgen.
This role is accountable for establishing and maintaining a robust, globally harmonized inspection framework aligned with applicable regulatory requirements and industry standards, while enabling effective execution at the site and enterprise levels.
Primary Responsibilities:
End‑to‑End Inspection Process Ownership
Owns the end‑to‑end GMP/GDP inspection process, including inspection preparation, conduct, response development, commitment tracking, and closure.
Ensures standardized governance, roles, and controls are in place to support consistent execution of inspections across sites and regions.
Leads continuous improvement of inspection processes through lessons learned, inspection trends, and feedback from health authority interactions.
Provides global process leadership during GMP/GDP inspections, supporting sites and enterprise stakeholders through inspection activities and regulatory interactions.
DQMS Business Ownership
Serves as business owner for the DQMS Operations Inspection module, with accountability for:
Functional requirements and lifecycle management
Data integrity, usability, and process alignment
Ongoing enhancements to support inspection execution, outcome tracking, and reporting
Partners with QMS, Digital, IT, ILM and Site stakeholders to ensure the module effectively supports global and site‑based inspection activities.
Cross‑GxP Inspection Alignment
Acts as primary liaison with GCP, GLP, and GPvP Inspection Process Owners to establish consistency and alignment across inspection lifecycle elements where appropriate.
Ensures inspection practices, metrics, and governance models are harmonized across GxP domains while respecting regulatory and operational differences.
Metrics, Monitoring & Management Review
Establishes, maintains, and governs a global inspection metrics control plan, including:
Inspection readiness indicators
Inspection outcomes and trends
Commitment timeliness and effectiveness
Owns data capture, maintenance, and integrity for inspection metrics supporting global and site‑based management reviews.
Supports ILM teammates for maintenance of site based inspection readiness dashboards.
Governance, Compliance & Continuous Improvement
Oversees inspection‑related standards, policies, procedures, and guidance documents within the QMS.
Leads gap assessments to new regulatory requirements and ensures alignment to regulatory commitments and inspection findings.
Partners with Learning & Development to define inspection‑related training content and capability‑building strategies.
Performs industry benchmarking and research to identify best practices, emerging trends, and enabling technologies, ensuring alignment with Quality governance expectations, including appropriate use of GenAI tools.
Collaborates across Regulatory Compliance, IDQ, ESQ, PAQ, R&D and other functional organizations to maintain and improve the end to end GMP/GDP inspection lifecycle processes.
Reporting Relationship
This position reports into the Head of the Inspection Lifecycle Management organization and operates with enterprise‑level accountability and influence across the global Quality network.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The quality compliance professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
Master’s degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Preferred Qualifications:
Prior experience leading or governing GMP/GDP inspections and regulatory interactions
Deep knowledge of global health authority inspection expectations and inspection lifecycle management
Experience owning or governing digital quality systems supporting inspections and regulatory commitments
Ability to operate strategically and tactically in a complex, global environment
Strong stakeholder engagement and executive communication skills
Demonstrated capability in driving operational excellence and continuous improvement across enterprise Quality processes
In order for the most productive global collaborations, ideal candidate would be based within a U.S. or Western European timezones
Travel would be limited to ad hoc workshops only if necessary for process or system improvements
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, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
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Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
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.
