Manager QA

Regulatory Toolkit; West Greenwich (RI); Presencial; USD 118.000 - 160.000; Jornada completa

Descripción de la vacante

Amgen is looking for a Manager QA to lead Quality Assurance teams covering Incoming Quality, Raw Material and Product Disposition, with oversight of warehouse QA. The role focuses on timely, compliant material disposition and cross-functional collaboration across site and network teams to improve processes and product quality.

Qualifications include extensive QA leadership with formal degrees (up to Doctorate) and hands-on experience in cGMP, deviations, CAPAs, and change controls.

Formación

• High school diploma / GED and 12 years of Quality experience OR
• Associate’s degree and 10 years of Quality experience OR
• Bachelor’s degree and 5 years of Quality experience OR
• Master’s degree and 3 years of Quality experience OR
• Doctorate degree
• In addition to meeting at least one requirement, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resources

Responsabilidades

• Lead QA teams for Incoming Quality, Raw Material, Product Disposition, and warehouse QA.
• Oversee incoming material inspection, sampling, testing, documentation review, disposition.
• Ensure timely, risk-based disposition decisions and proper documentation.
• Monitor metrics across Incoming Quality and disposition to drive improvements.
• Provide QA guidance for deviations and change controls.
• Represent QA on site and network teams for process direction and improvement.

Conocimientos

People leadership

Quality systems

Cross-functional collaboration

cgmp knowledge

Risk assessment

Educación

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

Herramientas

Trackwise

SAP

Veeva

Descripción del empleo

Career Category

Operations

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Manager QA

What you will do

Let’s do this! Let’s change the world!

In this vital role, you will lead Quality Assurance teams responsible for Incoming Quality, Raw Material and Product Disposition, and Quality oversight of Warehouse operations. The team supports the inspection, sampling, and testing of incoming raw materials and components; makes disposition decisions for raw materials and product; and provides Quality oversight of ARI warehouse operations, including floor support, receiving, sampling, dock operations, and shipping.

These responsibilities are closely connected: incoming material controls and warehouse practices support timely, compliant disposition and ultimately help ensure patients receive quality products. You will work broadly across the site and with network partners, including the global disposition network, to resolve issues and influence process improvements.

You will hire, develop, and lead Quality professionals, establish clear priorities, and foster a positive learning environment focused on quality, accountability, and continuous improvement.

Responsibilities include the following:

• Lead and empower teams responsible for Incoming Quality, Raw Material and Product Disposition, and warehouse Quality oversight.
• Oversee incoming material inspection, sampling, testing , documentation review, disposition and related Quality activities.
• Ensure raw material and product disposition decisions are timely, well documented, risk based, and consistent with approved procedures.
• Monitor key metrics across Incoming Quality and disposition to assess process health, identify trends, and lead improvement actions.
• Provide Quality oversight of warehouse operations, including receiving, material status control, storage, handling, dock activities, and shipping.
• Oversee the Raw Material Reject Cage and ensure rejected materials are appropriately controlled and managed.
• Provide Quality guidance for deviations and change controls, including assessment of potential impact to product quality, compliance, and supply.
• Lead resolution of impactful events using risk-based judgment, balanced thinking, and cross-functional collaboration.
• Review and approve cGMP processes, procedures, documents, and records, including nonconformances, deviations, CAPAs, change controls, validations, and raw material and drug substance documentation.
• Ensure changes that could affect product quality or compliance are assessed and managed in accordance with applicable procedures.
• Develop team capability through hiring, onboarding, training, coaching, and performance management.
• Communicate team goals, priorities, and performance expectations; coordinate actions to improve team and overall QA performance.
• Develop or contribute to procedures, standards, and operating practices that support consistent and compliant execution.
• Facilitate continuous improvement at the site and network levels across Incoming Quality, disposition, and warehouse quality processes.
• Represent QA on site, project, and network teams, including the global disposition network, and contribute to process direction and improvement.
• Partner with Supply Chain, Manufacturing, Quality Control, warehouse teams, and other stakeholders to resolve issues, establish direction, and support compliant and timely operations.
• Support audits and inspections related to the team’s areas of responsibility.
• Escalate quality, compliance, supply, and safety risks to senior management.

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 12 years of Quality experience OR
• Associate’s degree and 10 years of Quality experience OR
• Bachelor’s degree or and 5 years of Quality experience OR
• Master’s degree and 3 years of Quality experience OR
• Doctorate degree

In addition to meeting at least one of the above requirements, you must have 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:

• Experience working in a cGMP environment, with knowledge of quality systems such as deviations, CAPAs, change controls, and material or product disposition.
• Ability to interpret procedures and requirements, make sound Quality decisions, and communicate expectations clearly.
• Strong collaboration and problem-solving skills, including the ability to work across Quality, Supply Chain, warehouse, Manufacturing, and Quality Control teams.
• Ability to manage competing operational priorities while maintaining focus on product quality, compliance, and timely supply.
• Experience working in computerized quality systems of record, ie. Trackwise, SAP, Veeva.

What you can expect from 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.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

118,235.00USD -159,965.00USD