Senior Manager Quality Assurance (Quality Systems/Technical Services QA)

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.

Senior Manager Quality Assurance (Quality Systems/Technical Services QA)

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead a team of Quality professionals supporting Inspection and Packaging operations at our Juncos, Puerto Rico site. You will provide technical quality leadership and oversight of Quality Management Systems, partnering closely with cross-functional teams to build, enhance, and sustain compliant commercial operations.

As we continue to grow and expand through efficient and effective technology transfers, you will play a critical role in ensuring product quality meets both Amgen and regulatory standards. This position requires a regular onsite presence to drive results, foster collaboration, and ensure quality excellence.

Specific responsibilities include but are not limited to:

• Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for major projects and New Product Introductions, and Quality Systems (e.g., Document Management, Change Control, and Deviations).
• Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements.
• Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring.
• Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations.
• Serve as the site Quality Systems lead, driving consistency, standardization, and improvement across the facility and partnering with the global Amgen network to align on best practices.
• Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays.
• Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact.
• Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program.
• Champion and implement continuous improvement initiatives and digital innovations to enhance operational efficiency and data management within the department.
• Represent the Quality unit during internal and external audits and regulatory inspections.
• Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed.
• Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Sr. Manager QA we seek is a collaborative leader with these qualifications.

Basic Qualifications:

Doctor degree and 2 years of combined Quality and Manufacturing support industry experience

Or

Master’s degree and 6 years of combined Quality and Manufacturing support industry experience

Or

Bachelor’s degree and 8 years of combined Quality and Manufacturing support industry experience

OR

Associate’s degree and 10 years of combined Quality and Manufacturing support industry experience

OR

High School Diploma/GED and 12 years of combined Quality and Manufacturing support industry experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.  Your managerial experience may run concurrently with the required technical experience referenced above.

Beyond that, additional preferred qualifications are:

• Educational background in Life Sciences and/or Engineering.
• Proven experience in Quality oversight of parenteral inspection, assembly, packaging, and/or pharmaceutical operations, with a strong focus on quality systems.
• In-depth knowledge of cGMPs, regulatory requirements (including consumer-facing CFSCRs), and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice.
• Hands-on experience with validation, change control, and Quality Systems—particularly investigations, corrective actions, and audit readiness.
• Experience managing and interacting with regulatory and internal auditors.
• Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills.
• Effective risk management, negotiation, and cross-functional collaboration abilities.
• Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish.

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.

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 & vision coverage, life and disability insurance
• 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.