Amgen Hiring: Sr Manager QA – Quality Validation & Technical Services

Amgen is hiring a Sr Manager QA – QVTS (Quality Validation & Technical Services) at its site in Holly Springs, North Carolina, USA. This is a senior Quality Assurance leadership opportunity focused on quality oversight of facility and equipment design, installation, commissioning and qualification, process qualification, GMP compliance and operational readiness.

The Sr Manager QA will work cross-functionally with Manufacturing, Facilities & Engineering and other support functions to provide quality expertise throughout facility start-up and ongoing operations.

Job Details

Job Information	Details
Company	Amgen
Job Title	Sr Manager QA – QVTS
Full Title	Sr Manager QA – Quality Validation & Technical Services
Job ID	R-257052
Location	Holly Springs, North Carolina, USA
Work Location	On Site
Job Category	Quality
Posted Date	October 5, 2026
Salary Range	$144,021.45 – $194,852.55 per year
Application Deadline	No fixed deadline
Function	Quality Assurance / Quality Validation & Technical Services

The official Amgen posting states that applications will continue until a sufficient number of candidates are received or a candidate is selected.

About the Sr Manager QA Role

The Sr Manager QA will provide Quality oversight for the design, installation, commissioning and qualification (CQV), and process qualification of a new facility and equipment.

This position will collaborate across the organization throughout construction, facility start-up, operational readiness and operations to help ensure project milestones are achieved while maintaining compliance with applicable GMP requirements.

The Sr Manager QA will also provide quality expertise and guidance for strategic and tactical decisions involving cGMP processes, procedures, protocols, assays, documentation, records, quality systems and compliance activities.

Key Responsibilities

Quality Oversight

The Sr Manager QA will:

• Lead Quality activities associated with facility and equipment design.
• Provide Quality oversight during installation, commissioning and qualification.
• Support process qualification activities.
• Ensure facilities, equipment, materials, processes and products remain aligned with cGMP requirements.
• Provide Quality and compliance expertise for execution strategies.
• Support quality review and approval of documents associated with facility commissioning and qualification.

GMP and Quality Compliance

The Sr Manager QA will ensure that Quality Unit activities appropriately review, approve and track cGMP processes, procedures, protocols, assays, documents and records.

This includes activities such as:

• Work Orders
• Deviations
• CAPA
• Change Controls
• Qualification documentation
• Validation-related documentation
• Quality records
• GMP procedures and protocols

The role also ensures that facilities, equipment, materials and processes comply with applicable regulations and Amgen requirements relating to GMP, Good Documentation Practices, safety and controls.

Cross-Functional Collaboration

A major part of the Sr Manager QA position is collaboration across multiple functions.

The successful candidate will work with:

• Manufacturing
• Facilities & Engineering
• Quality
• Project teams
• Technical and support functions
• Other Amgen sites and enterprise teams

The objective is to provide effective Quality guidance while supporting project execution, compliance and operational readiness.

Quality Management System

The Sr Manager QA will collaborate across the Amgen enterprise to ensure Quality Management System processes are implemented, maintained and executed according to established procedures and applicable regulations.

The position will also identify opportunities for continuous improvement and help drive effective quality and compliance practices.

Team Leadership

The Sr Manager QA will build and manage a strong team of Quality professionals.

Key leadership responsibilities include:

• Developing Quality professionals.
• Providing coaching and direction.
• Building an effective Quality organization.
• Supporting current and future facilities.
• Promoting strong collaboration.
• Driving quality-focused decision-making.
• Supporting employee development and performance.

Audits, Inspections and Investigations

The Sr Manager QA will represent the Quality Unit during audits and regulatory inspections as required.

The role will also ensure that deviations from established procedures are appropriately investigated and documented according to applicable procedures.

Strong knowledge of regulatory requirements, industry standards and risk-based Quality decision-making is therefore important for this leadership position.

Qualifications and Experience

Basic Qualifications

Amgen lists the following qualification pathways for the Sr Manager QA position:

• High school diploma/GED plus 12 years of Quality and/or Operations experience; or
• Associate’s degree plus 10 years of Quality and/or Operations experience; or
• Bachelor’s degree plus 8 years of Quality and/or Operations experience; or
• Master’s degree plus 6 years of Quality and/or Operations experience; or
• Doctorate degree plus 2 years of Quality and/or Operations experience.

In addition, candidates must have at least 2 years of direct people-management experience and/or leadership experience involving teams, projects, programs or resource allocation. Amgen notes that managerial experience may run concurrently with the required technical experience.

Preferred Qualifications

Candidates with the following experience may be particularly well suited for the Sr Manager QA opportunity:

• 2+ years of management experience at a senior Quality level.
• Experience with, or strong understanding of, biologics drug substance operations.
• Strong understanding of regulatory requirements, regulatory trends and industry standards.
• Ability to provide sound Quality guidance.
• Strong data-driven and risk-based decision-making skills.
• Excellent written and verbal communication.
• Strong leadership and people-development capabilities.
• Ability to develop, coach, empower and retain employees.
• Strong cross-functional collaboration and problem-solving skills.
• Experience with Quality oversight of commissioning, qualification and validation.

These preferred qualifications are taken from the current Amgen job posting.

Salary and Benefits

The published annual U.S. salary range for this Sr Manager QA role is:

$144,021.45 – $194,852.55

Amgen states that actual compensation may vary depending on relevant skills, experience and qualifications.

Eligible employees may also receive a Total Rewards package that can include:

• Health and welfare benefits.
• Medical, dental and vision coverage.
• Retirement and savings plans.
• Life and disability insurance.
• Flexible spending accounts.
• Annual bonus opportunities.
• Stock-based long-term incentives.
• Paid time off.
• Career development opportunities.

Benefits and eligibility are subject to Amgen’s applicable plans and policies.

Why Join Amgen?

Amgen is a biotechnology company focused on developing innovative medicines for serious diseases. The company says its mission is centered on serving patients living with serious illnesses.

For a Quality professional, this Sr Manager QA opportunity provides exposure to facility start-up, commissioning and qualification, process qualification, GMP compliance, Quality Systems and senior-level Quality leadership.

Application Information

Position: Sr Manager QA – QVTS
Job ID: R-257052
Location: Holly Springs, North Carolina, USA
Work Location: On Site
Posted: October 5, 2026
Salary: $144,021.45–$194,852.55 annually

Interested candidates should apply through the official Amgen Careers website.

Official Job Posting: Amgen Careers – Sr Manager QA – QVTS

Frequently Asked Questions

What is the Sr Manager QA position at Amgen?

The position is Sr Manager QA – QVTS (Quality Validation & Technical Services).

Where is the Sr Manager QA job located?

The job is located in Holly Springs, North Carolina, USA.

Is the Sr Manager QA position onsite?

Yes. Amgen lists the work location type as On Site.

What is the Amgen job ID?

The job ID is R-257052.

What does the Sr Manager QA do?

The Sr Manager QA provides Quality oversight for facility and equipment design, installation, commissioning and qualification, process qualification, GMP compliance and operational readiness.

What experience is required?

Amgen provides several education-and-experience pathways, ranging from a high school diploma/GED with 12 years of Quality/Operations experience to a doctorate with 2 years of experience. At least 2 years of people-management or relevant leadership experience is also required.

Is biologics experience preferred?

Yes. Amgen lists experience in, or a strong understanding of, biologics drug substance operations as a preferred qualification.

What is the salary for this position?

The published U.S. annual salary range is $144,021.45 to $194,852.55, with actual compensation depending on skills, experience and qualifications.

Does the position have an application deadline?

There is no fixed application deadline listed. Amgen states that applications will remain open until enough candidates are received or a candidate is selected.

Is sponsorship available?

Amgen states that sponsorship for this role is not guaranteed. Candidates should review their individual eligibility and the official application information before applying.

Important Note for Applicants

Candidates should apply only through verified Amgen recruitment channels. Amgen warns applicants about recruitment scams and states that legitimate Amgen communications will come through Amgen-associated channels. Applicants should never pay money, purchase gift cards or provide banking information as part of an application or interview process.