Jobs in the United States

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Added 1 min ago
VH
RN-Associate Director for Patient Care Service/Nurse Executive
Veterans Health Administration
Atlanta, GA · Birmingham, AL
- $207,243 to $228,000 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 1 min ago
VH
Registered Nurse - Community Care
Veterans Health Administration
Bath, NY · Canandaigua, NY
- $74,106 to $129,998 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 1 min ago
VH
Assistant Nurse Manager
Veterans Health Administration
Muskogee, OK
- $91,339 to $161,196 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 1 min ago
VH
Registered Nurse- Cardiac Catheterization Lab
Veterans Health Administration
Minneapolis, MN
- $93,448 to $159,842 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 1 min ago
DC
Store Associate
Defense Commissary Agency
Camp Pendleton, CA
- $41,591 to $54,071 USD / year
…unpaid), including volunteer work done through National Service program (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual;…
Added 1 min ago
DC
Store Associate
Defense Commissary Agency
Camp Pendleton, CA
- $41,591 to $54,071 USD / year
…unpaid), including volunteer work done through National Service program (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual;…
Added 1 min ago
VH
Registered Nurse-Wound Care
Veterans Health Administration
Amarillo, TX
- $82,778 to $153,671 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 4 mins ago
VH
Registered Nurse - Patient Aligned Care Team
Veterans Health Administration
Fort Meade, SD
- $66,367 to $127,336 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 4 mins ago
VH
Registered Nurse - Inpatient Staff
Veterans Health Administration
Buffalo, NY
- $75,760 to $139,451 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 4 mins ago
VH
Registered Nurse (Perioperative)
Veterans Health Administration
Atlanta, GA
- $91,113 to $160,118 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 4 mins ago
VH
Registered Nurse - Inpatient Staff Nurse
Veterans Health Administration
Buffalo, NY
- $75,760 to $139,451 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 4 mins ago
AE
TRAINING INSTRUCTOR (AIRCRAFT MAINTENANCE)
Air Education and Training Command
Sheppard AFB, TX
- $61,722 to $80,243 USD / year
…standards established by the Secretary of Education to confer associate degrees upon enlisted members who have completed the requirements for the prescribed programs of study. To comply…
Added 8 mins ago
VH
Registered Nurse - Wound Care
Veterans Health Administration
Indianapolis, IN
- $68,174 to $120,511 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 8 mins ago
VH
Registered Nurse (RN) - Primary Care
Veterans Health Administration
Long Beach, CA · Santa Fe Springs, CA
- $111,502 to $190,737 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 8 mins ago
VH
Registered Nurse - Endoscopy, Intermittent
Veterans Health Administration
Indianapolis, IN
- $74,102 to $130,296 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 8 mins ago
VH
Registered Nurse-Clinical Nurse Educator
Veterans Health Administration
Amarillo, TX
- $82,778 to $153,671 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 8 mins ago
CN
Child & Youth Program Leader
Commander, Navy Installations Command
Gulfport, MS
- $24 to $25 USD / hour
…provision of guidance, assistance, and mentoring for the CY Program Assistants. The incumbent works under the direction of the supervisor or other qualified higher graded employee, who…
Added 8 mins ago
CN
Child and Youth Program Assistant May be eligible for 1000.00 Incentive at 6 mo. and 1 year
Commander, Navy Installations Command
Mechanicsburg, PA
- $19 to $24 USD / hour
The duties and responsibilities of the CY Program Assistant have been grouped into categories, including curriculum, indoor and outdoor environment, interactions and relationships,…
Added 8 mins ago
CN
Child and Youth Program Leader May be eligible for 1000.00 Incentive at 6 mo. and 1 year
Commander, Navy Installations Command
Mechanicsburg, PA
- $25 to $26 USD / hour
…provision of guidance, assistance, and mentoring for the CY Program Assistants. The incumbent works under the direction of the supervisor or other qualified higher graded employee, who…
Added 8 mins ago
VH
RN-Inpatient Mental Health
Veterans Health Administration
Oklahoma City, OK
- $75,766 to $140,903 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 8 mins ago
MT
Nurse (Clinical)
Military Treatment Facilities under DHA
Bethesda, MD
- $103,603 to $134,691 USD / year
Degree:A graduate or higher level degree, bachelor's degree, associate degree, or diploma from an accredited professional nursing educational program is required. This education must have…
Added 8 mins ago
CN
Child and Youth Program Assistant May be eligible for 1000.00 Incentive at 6 mo. and 1 year
Commander, Navy Installations Command
Mechanicsburg, PA
- $19 to $24 USD / hour
The duties and responsibilities of the CY Program Assistant have been grouped into categories, including curriculum, indoor and outdoor environment, interactions and relationships,…
Added 8 mins ago
VH
Outpatient Staff Registered Nurse (RN) (Cardiology Clinic)
Veterans Health Administration
Phoenix, AZ
- $89,703 to $166,144 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 11 mins ago
VH
Registered Nurse - Spinal Cord Injury
Veterans Health Administration
Long Beach, CA
- $114,291 to $195,498 USD / year
…by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on…
Added 11 mins ago
VH
Lead Diagnostic Radiologic Technologist
Veterans Health Administration
Detroit, MI
- $74,451 to $96,791 USD / year
…equivalent) in a post-high school diagnostic radiologic technology program, evidenced by a certificate or an associate degree, accredited by the Joint Review Committee on Education in…

Amgen

Sr Specialist Quality Compliance

West Greenwich, RI, United States

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Job details

Posting language: English
Posted: Nov 1, 2026

Original 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. J

Sr Specialist QA - Compliance

What you will do

Let’s do this. Let’s change the world. In this vital role, you will provide site-level leadership for inspection readiness across both manufacturing facilities, driving a sustained state of readiness for regulatory inspections, corporate and internal audits, and customer audits. You will lead the development and execution of readiness strategies, establish clear governance and accountability, and influence cross-functional partners to identify and address risks before they affect inspection outcomes. As a primary site coordinator, you will oversee inspection logistics including schedules, rooms, escorts, subject matter expert support, document retrieval, communications, and daily inspection management while adapting plans and resources as inspection priorities evolve. This role requires sound judgment, decisive action, and the ability to pivot quickly in a dynamic environment, align leaders and teams under time-sensitive conditions, and escalate emerging issues with clear recommendations.

Key Responsibilities:

Partner across functions to maintain a continuous inspection-ready state for a multi-product GMP manufacturing operation.
Develop, maintain, and continuously improve site inspection readiness programs, tools, trackers, playbooks, and governance processes.
Coordinate cross-functional readiness plans for upcoming Health Authority inspections and major audits, including mock inspections, war-room preparation, document review, and interview readiness.
Support inspection and audit strategy for new product introductions to ensure new processes, facilities, systems, documents, and personnel are inspection ready prior to implementation and filing-related activities.
Ensure inspection-related commitments, actions, and deliverables are clearly assigned, tracked to completion, and escalated as needed.
Facilitate cross-functional alignment on inspection narratives, site presentations, supporting data packages, and response coordination.
Support preparation and maintenance of core inspection readiness content, including site overviews, facility maps, product flow summaries, SME rosters, document inventories, and inspection support tools.
Coordinate document management and retrieval processes to support efficient and controlled responses during inspections and audits.
Monitor readiness of quality systems and operational processes that are commonly scrutinized during inspections, including deviations, CAPAs, change control, risk management, complaints, training, validations, document management, and data integrity controls.
Identify gaps, risks, or weak points that may affect inspection outcomes and work with functional owners to drive timely remediation.
Facilitate and manage monthly management review
Support site self-assessments and gap assessments against cGMP requirements, internal standards, and regulatory inspection trends.
Develop and sustain close working relationships with internal stakeholders and external business partners, to ensure aligned and effective audit and inspection support.
Ensure lessons learned from prior inspections, audits, commitments, and industry enforcement actions are incorporated into site readiness activities.
Track regulatory commitments and support timely follow-up to ensure inspection observations, actions, and commitments are completed and sustainable.
Provide compliance support during inspections, including schedule management, room coordination, request tracking, communication support, and facilitation of cross-functional issue resolution.
Support drafting, coordination, and review of inspection responses and related action plans, as applicable.
Escalate significant quality, compliance, supply, and inspection readiness risks to site quality and senior leadership.
Support continual improvement initiatives that strengthen site quality culture, inspection readiness capability, and execution discipline.

What we expect of you

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

Basic Qualifications

High school diploma / GED and 12 years of regulatory compliance experience OR
Associate’s degree and 10 years of regulatory compliance experience OR
Bachelor’s degree and 6 years of regulatory compliance experience OR
Master’s degree and 4 years of regulatory compliance experience OR
Doctorate degree and 2 years of regulatory compliance experience

Preferred Qualifications

Bachelor’s Degree in Life Sciences or Engineering
7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, data analysis, project management, and quality systems
Experience leading or coordinating inspection and audit activities, including managing information requests, preparing subject matter experts, supporting interviews, and coordinating inspection responses.
Experience with leading and/or participating in key roles to prepare for, execute and/or respond to outcomes from Health Authority inspections
Experience in auditing and/or defending processes, procedures and decisions during Health Authority inspections
Strong working knowledge of cGMP requirements and quality systems commonly assessed during inspections, including deviations, CAPAs, change control, training, validation, document management, and data integrity.
Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively
Demonstrated ability to identify compliance risks and readiness gaps, lead cross-functional remediation, and ensure actions are completed and sustained.
Experience managing staff and/or leading cross-functional teams, projects and/or programs
Thorough working knowledge of EU and US Good Manufacturing Practices (cGMPs)
Previous exposure to bulk drug substance manufacturing and quality assurance processes
Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach

What you can expect of 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.

Apply now and make a lasting impact with the Amgen team.

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.

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More about this job

Skills

Regulatory compliance
Leadership
Inspection
Internal auditing
Logistics
Good manufacturing practices
Presentation skills
Document management
Quality control systems
Risk management
Communication skills
Quality assurance
Pharmaceutical industry
Data analysis
Project management
Auditing
Work independently
Manage quantitative data
Quality assurance methodologies
Problem solving
Compensation and benefits
Sales

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