Manager QA

Amgen•West Greenwich, RI

17d•$118,235 - $159,965

About The Position

The Manager QA leads 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; disposition of raw materials and products; and Quality oversight of warehouse activities, including receiving, sampling, dock operations, and shipping. The role works across the site and with network partners, including the global disposition network, to resolve issues and improve processes. The manager hires, develops, and leads Quality professionals, sets priorities, and fosters a learning environment focused on quality, accountability, and continuous improvement.

Requirements

High school diploma or 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.
Experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing allocation of resources. Managerial experience may run concurrently with the required technical experience.

Nice To Haves

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, such as Trackwise, SAP, or Veeva.

Responsibilities

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, 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 impacts 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 according to 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.

Benefits

Health and welfare plans for staff and eligible dependents
Retirement and Savings Plan with company contributions
Group medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program, or sales-based incentive plan for field sales representatives
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities