Manager QA - Drug Substance Jobs

Manager QA - Drug Substance

Amgen

Location:
United States, Juncos

Category:
Quality Control

Contract Type:
Not provided

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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Manager QA - Drug Substance

Amgen

Location:
United States, Juncos

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 18, 2025

Looking for more opportunities? Search for other job offers that match your skills and interests.

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Manager QA - Drug Substance

Amgen

Location:United States, Juncos

Category:Quality Control

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:December 18, 2025

Looking for more opportunities? Search for other job offers that match your skills and interests.

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