Amgen
Senior Manager Quality Assurance – Major Deviations Lifecycle Team
US - Puerto Rico - Juncos · Senior
Sponsorship not specifiedDetected 1 day ago
ComplianceStakeholder ManagementSupply ChainPerformance ManagementGMPFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingMentoringOrganizational SkillsRegulatory Affairs
About the role
- 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.
Responsibilities
- In this vital role you will be responsible for leading the Major Deviations Team and ensuring the timely, compliant, and effective management of significant quality events across manufacturing, packaging, laboratory, and support operations.
- Lead and manage the Major Deviations Team, including performance management, coaching, employee development, and resource planning.
- Drive effective root cause analyses using structured investigation methodologies and risk-based decision-making.
- Maintain accountability for: Timely initiation and designation of deviations, Robust root cause investigations, Accurate documentation within the digital quality management system (DQMS), Effective CAPA and effectiveness verification (EV) execution.
- Collaborate with cross-functional teams to identify systemic issues and implement sustainable corrective actions.
- Support internal audits, regulatory inspections, and customer audits related to deviation management and quality systems.
- Lead major deviation improvement programs and strategic initiatives involving multiple departments, quality systems, or business processes.
- Support the implementation and optimization of electronic quality management systems.
Requirements
- Doctorate degree and 2 years of quality support experience
- Master's degree and 6 years of quality support experience
- Bachelor's degree and 8 years of quality support experience
- Associate's degree and 10 years of quality support experience
- Your managerial experience may run concurrently with the required technical experience referenced above.
Nice to have
- Strong understanding of cGMP regulations and FDA, EMA, and global regulatory expectations.
- 8+ years of experience in Quality Assurance, Quality Systems, Manufacturing, or Compliance within the pharmaceutical, biotechnology, or another regulated industry.
- Strong experience managing major deviations, investigations, CAPAs, and regulatory interactions is preferred.
- Knowledge of electronic quality systems and data-trending tools with expertise in deviation investigation methodologies and quality risk management principles.
- Experience leading and supporting inspection readiness and regulatory audits.
- 3+ years of leadership or people management experience with the ability to lead cross-functional teams within a fast-paced, highly regulated environment
- Strong analytical, problem-solving, and decision-making skills.
- Solid communication and presentation skills, with the ability to influence stakeholders at multiple organizational levels.
Compensation
- 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,
Company info
- We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- 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.
- Please contact us to request accommodation.
- 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.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.