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Manager QA - Drug Substance

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Amgen

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Location:
United States , Juncos

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

In this vital role in support to Amgen’s Quality Assurance program, we are seeking a highly motivated and proactive leader to join us as Manager QA, to lead and oversee the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico in a non-standard shift operation (night shift).

Job Responsibility:

  • Lead the Quality team for assigned plant(s) or functional area(s), overseeing staffing, training, supervision, and performance management
  • Ensure products are manufactured, tested, stored, and distributed in compliance with cGMP, GDP, and applicable regulations
  • Maintain compliance of facilities, equipment, materials, processes, procedures, and products with cGMP and regulatory standards
  • Review, approve, and track cGMP documentation, including NCs, CAPAs, Change Controls, validations, and assays
  • Approve Master Production Records (MPs), process validation protocols and reports, Environmental Characterization reports, and planned incidents
  • Represent QA in New Product Introduction (NPI) teams and during audits and inspections
  • Lead investigations and plant audits
  • approve change-over completion activities
  • Ensure deviations are properly investigated and documented
  • verify accuracy and completeness of production records and test results
  • Collaborate cross-functionally to ensure QMS processes follow established procedures
  • Bring up quality, compliance, supply, and safety risks to senior management
  • Ensure controlled documents have assigned owners and that periodic reviews are completed on time

Requirements:

  • Doctorate degree
  • Or Master’s degree and 3 years of experience in regulated industry experience
  • Or Bachelor’s degree and 5 years of experience in regulated industry experience
  • Or Associate’s degree and 10 years of experience in regulated industry experience
  • Or High school diploma / GED and 12 years of experience in regulated industry experience
  • Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
  • Managerial experience may run concurrently with the required technical experience

Nice to have:

  • Educational background in Life Sciences or Engineering
  • Experience with processes involved with Quality Assurance, manufacturing and distribution, Quality Control, validation, and process development
  • Validated expertise in Quality Systems such as Deviations, CAPA and Change Control
  • Experience leading cross functional teams with the influencing and negotiating skills
  • Strong organizational, project management and change management skills
  • Strong communication skills (both written and oral), and comprehend in English and Spanish
  • Ability to provide direction and establish goals for individual staff members and work groups, empower staff, manage and distribute workloads
  • Ability to interact with regulatory agencies
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & 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 and an annual site shutdown
  • Flexible work models, including remote work arrangements, where possible

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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