CrawlJobs Logo

Quality Assurance Senior Manager

United States 132037.30 - 178638.70 USD / Year · Job Posted May 06, 2026
Apply Position
Job Link Share

Job Description

In this role of Quality Senior Manager you will be responsible for quality oversight of multiple secondary packaging components external suppliers which provide global goods and services to Amgen. You will be part of a multifunctional team and work within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. You will work closely with External Supply, Process Development, Combination Product Quality, and various other parts of Operations. This role also has regional responsibilities across multiple manufacturing sites. The Quality Senior Manager will report into Associate Director of External Supply Quality for North America. This role can be filled in multiple locations in US, but proximity close to Amgen's advanced packaging facility in Ohio is preferred. Travel may be required.

Job Responsibility

  • Ensure appropriate quality oversight of suppliers in line with global regulations, defines quality requirements for suppliers and monitors performance
  • Monitors and assigns quality status and, if required, determines remediation actions and additional oversight needed, including technical site visits
  • Maintains key quality performance indicators for suppliers of responsibility
  • Review and approval of quality records such as
  • Quality Agreements, supplier investigations, deviations, supplier change notifications, change controls, CAPAs, and CAPA-EV's
  • Manage supplier audits to completion
  • Act as point of contact for Amgen sites to resolve concerns and support projects regarding secondary packaging materials and suppliers
  • Represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site
  • Identify and mitigate risks at supplier site and raise to management as appropriate
  • Onboard and offboard suppliers and/or manufacturing location as needed
  • Lead departmental improvement projects regarding continuous improvement and automation

Requirements

  • Doctorate degree and 2 years of Quality and Compliance experience
  • Master's degree and 4 years of Quality and Compliance experience
  • Bachelor's degree and 6 years of Quality and Compliance experience
  • Associate's degree and 10 years of Quality and Compliance experience
  • High school diploma / GED and 12 years of Quality and Compliance experience
  • Educational background in Life Sciences
  • Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
  • Relevant work experience within Drug Product and Finished Drug Product operations
  • 5+ years of experience overseeing quality of suppliers
  • Robust problem-solving and root-cause analysis experience
  • Strong continuous improvement mentality
  • Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive with an end-to-end mentality
  • Strong communication skills with proficiency in the English language and collaborative cross-functionally behavior
  • Strong report writing and presentation skills
  • Experience driving decision-making by using DAI principles
  • Understanding of industry requirements/expectations of a QMS
  • Savvy with data and Artificial Intelligence tools
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

Nice to have

Knowledge of Primary and Secondary packaging is a plus

What we offer

  • 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

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Quality Assurance Senior Manager

8 matching positions

Senior Manager Quality Assurance: Incoming Quality and Warehouse

At Amgen, if you feel like you’re part of something bigger, it’s because you are...
Location
Location
United States , New Albany
Salary
Salary:
144021.45 - 194852.55 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of Quality/Manufacturing/Engineering experience
  • Master's degree and 6 years of Quality/Manufacturing/Engineering experience
  • Bachelor's degree and 8 years of Quality/Manufacturing/Engineering experience
  • Associate's degree and 10 years of Quality/Manufacturing/Engineering experience
  • High school diploma / GED and 12 years of quality/Manufacturing/Engineering experience
  • minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Job Responsibility
Job Responsibility
  • Lead, coach and develop the QA team, responsible for quality oversight of Incoming Quality, Warehouse Operations, Distribution and Facility and Engineering. Team scope includes disposition of product, materials and components, including on-the-floor support, record review, quality oversight of deviation investigations and changes, document approval
  • Ensure AOH product is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and applicable regulations
  • Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
  • Lead and participate in Quality Risk Assessments
  • Provide Quality input to support project or operational design decisions
  • Build organization according to hiring strategy that supports our growth. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs
  • Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
  • Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
  • Develop strategies in support of regulatory inspections and site audits
  • Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
What we offer
What we offer
  • health and welfare plans for staff and eligible dependents
  • financial plans with opportunities to save towards retirement or other goals
  • work/life balance
  • career development opportunities
  • 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
  • discretionary annual bonus program
  • stock-based long-term incentives
  • award-winning time-off plans
  • flexible work models where possible
  • Fulltime
Read More
Arrow Right

Senior Manager, Quality Assurance & Operations Excellence

The Senior Manager, Performance Improvement & Development (SMPID), Residential O...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
https://www.marriott.com Logo
Marriott Bonvoy
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced in MS PPT including dynamic elements, such as videos, visually represented data, and interactive modules
  • Advanced in MS Excel including PivotTables, VLOOKUP, INDEX/MATCH and Data Tables
  • Skills in facilitating improvement strategies, managing quality improvement teams and complex projects
  • Ability to communicate and train all levels of the organization
  • Aptitude to analyze data and prepare reports of findings
  • Practical application of statistical methods and tools
  • Advanced knowledge of MS Teams platform
  • Ability to develop and deliver virtual and in-person presentations and training classes
  • Advanced knowledge of systems including GXP, BuildingLink, Digital Learning Zone, MHUB, MESH, TrueView, Land-It, Just Report It, Gallup Online, Transcendent, Marriott Asset Library, 4DX, Tableau
  • Travel 30% to 50%
Job Responsibility
Job Responsibility
  • Responsible for implementing property scorecards to measure
  • Responsible for initiating problem-solving communication with property senior leadership team when necessary, in order to ensure continent success
  • Responsible for sharing best practices within continent
  • Responsible for training and development of new property Leaders on Residential specific training including quality tools
  • Responsible for learning execution including in person and virtual training
  • Responsible for providing support prior to an opening and leading countdown process for residential openings
  • Responsible for distribution of digital Personalized Service Flashcards
  • Responsible for developing and maintaining all scorecards/dashboards
  • Responsible for auditing and maximizing usage of all systems
  • Responsible for Owner Engagement Survey sample, daily participation reporting, bi-annual impact plan audit
What we offer
What we offer
  • Equal opportunity employer
  • Rich blend of culture, talent, and experiences
  • Fosters an environment of inclusion
  • Dedicated to non-discrimination on any protected basis
  • Fulltime
Read More
Arrow Right

Senior Quality Assurance Manager

Our candidate is seeking an opportunity to lead a capable technical team, to dri...
Location
Location
Australia , Sydney
Salary
Salary:
160000.00 AUD / Year
elevatingfoodsafety.com Logo
Elevating Food Safety
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 25+ Years Experience
  • HACCP
  • Lead Auditor
  • SQF
  • excellent communicator
  • effective analytical and problem-solving ability
  • time management
  • organisational
  • B. Applied Science Food Packaging and Technology
Job Responsibility
Job Responsibility
  • Lead a capable technical team
  • Drive business development and improvement
Read More
Arrow Right

Senior Quality Assurance Manager

SCAYLE is one of the fastest-growing enterprise commerce platforms worldwide, em...
Location
Location
Germany , Hamburg or Berlin
Salary
Salary:
65000.00 - 75000.00 EUR / Year
aboutyou.de Logo
About You
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 5 years of experience in quality assurance, testing, and debugging of frontend applications, preferably in agency or client-facing environments
  • Proficient in manual testing techniques, including exploratory and destructive testing, as well as automated testing methodologies
  • Familiarity with project management and ticketing tools such as Jira and Confluence for effective collaboration across agency teams and client stakeholders
  • Strong knowledge and experience with testing tools, particularly TestRail, for efficient test management and comprehensive reporting
  • Ability to quickly understand complex, custom-built e-commerce implementations and adapt testing approaches to different client architectures
  • Web technologies: Solid understanding of HTML, CSS, JavaScript, browser developer tools, and REST APIs
  • Experience working with agile methodologies in fast-paced agency environments with multiple concurrent projects
  • Passion for delivering innovative, client-specific features quickly while maintaining the high reliability standards expected by premium brands
  • Detail-oriented approach with strong focus on test case design, business value, brand consistency, and exceptional user experience
  • Excellent communication skills for working directly with high-profile clients and articulating technical issues clearly
Job Responsibility
Job Responsibility
  • Perform high-quality manual testing across multiple client e-commerce projects (Desktop, Mobile Web and Tablet), covering the complete customer journey from discovery to checkout
  • Collaborate closely with frontend developers and project teams to understand client requirements and develop tailored testing strategies for each implementation
  • Oversee quality across diverse client implementations while ensuring consistent excellence and optimal user experiences
  • Take ownership of bug reports and tickets from clients, internal stakeholders, and end-users, prioritizing them based on business impact and project timelines
  • Contribute to the development and evolution of SCAYLE Agency’s testing framework and automated testing strategy across client projects
  • Act as a quality advocate within cross-functional agency teams, promoting best practices and driving continuous improvement across multiple client engagements
  • Coordinate testing efforts across parallel client projects to ensure successful delivery of high-quality features within agency timelines
  • Support holistic testing approaches across the full technology stack, understanding how frontend integrations connect with SCAYLE’s backend systems and third-party services
  • Adapt testing strategies to accommodate varying client requirements, brand guidelines, and technical specifications
What we offer
What we offer
  • Hybrid working
  • Fresh fruit every day
  • Sports courses
  • Free access to code.talks
  • Exclusive employee discounts
  • Free drinks
  • Language courses
  • Company parties
  • Help in the relocation process
  • Mobility subsidy
  • Fulltime
Read More
Arrow Right

Senior Quality Assurance Project Manager

The Senior Project Manager has overall responsibility for the quality assurance ...
Location
Location
United States , Albany
Salary
Salary:
75062.00 - 150000.00 USD / Year
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum eight (8) years or more of progressive experience with project management related tasks, including initiation, planning, executing, monitoring and controlling tasks, and preparing and using all PM management plans, as described by Project Management Institute (PMI) Project Management Body of Knowledge (PMBOK)
  • Minimum five (5) years of experience applying PMI project management practices managing quality assurance projects, activities, and tasks
  • Minimum five (5) years of experience working with team size of 10 or more staff
  • Minimum three (3) years of experience with MS Project, including baselining, tracking progress, resource usage and reporting progress against planned schedule
  • Bachelor’s degree in information technology, Business Administration, or similar field
  • Willing to be on the client site in Albany New York 50% of the time.
Job Responsibility
Job Responsibility
  • Ensuring quality is built into large projects or programs or significant segments of a large complex project or program
  • Working with the client and team members to ensure business requirements are fully documented in the business requirements documents (BRD) or similar documents and meet quality standards
  • Assessing the quality of contractor submitted project deliverables such as Project Schedules, Status Reports, and Risks, Actions, Issues, and Decision (RAID) logs
  • Leading a QA team in providing quality assurance throughout the SDLC, including QA for initiating, planning, controlling, executing, and closing tasks of a project or program to produce the solution deliverable
  • Applying SDLC methodologies and frameworks which may include Waterfall, Agile, Hybrid, DevOps, DevSecOps in a Cloud or On-Prem environment
  • Anticipating potential quality-related problems and manages risks, issues, escalations, and communication(s)
  • As appropriate, challenging the validity of given procedures and processes with a view toward continuous improvement
  • Performing reviews to accuracy of various contract deliverables from contractors, such as submitted invoices, SLAs, replacement staff resumes, etc.
  • Managing the QA team assignments and schedules to ensure timely review of submitted artifacts
  • Facilitating information sharing among the entire QA project team to identify risks issues, and opportunities associated with system interoperability
What we offer
What we offer
  • Medical
  • Dental
  • Vision insurance with an employer contribution
  • Flexible spending or health savings account
  • Life and AD&D insurance
  • Short and long term disability coverage
  • Paid time off
  • Employee assistance
  • Participation in a 401k program with company match
  • Additional voluntary or legally-required benefits
  • Fulltime
Read More
Arrow Right

Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets...
Location
Location
Singapore
Salary
Salary:
Not provided
avanos.com Logo
Avanos
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a relevant scientific or technical discipline
  • 6-10 years of experience in the medical device industry
  • Proven leadership experience with a track record in managing teams and developing long-term strategic initiatives
  • Strong written and verbal communication skills
  • Experience with regional or international regulatory submissions preferred
  • Strong computer proficiency
  • Understanding of regulatory requirements across major APAC markets
  • Familiarity with mandatory Quality Management System requirements across APAC
  • General knowledge of US FDA regulations (21 CFR, FDA guidelines) and EU CE marking processes is an advantage
Job Responsibility
Job Responsibility
  • Provide strategic Regulatory Affairs and Quality leadership for all APAC markets where Avanos operates
  • Partner with global and regional stakeholders to ensure full compliance with regulatory requirements, support business objectives, and strengthen the RA/QA capability across the region
  • Serve as an active member of the Global Regulatory & Clinical Affairs, Global Quality, and APAC Leadership Teams
  • Provide Regulatory and Quality leadership across all APAC markets
  • Recruit, build, and develop in-country RA/QA teams
  • Advise APAC cross-functional teams and Global RA & Clinical Affairs and Global Quality functions on regional regulatory requirements
  • Oversee the preparation, submission, and lifecycle maintenance of product registrations across APAC
  • Maintain regulatory databases
  • Direct the development and maintenance of regulatory systems and processes
  • Develop APAC regulatory strategies
What we offer
What we offer
  • comprehensive and competitive range of benefits
  • health care benefits
  • retirement plans
  • work/life benefits
Read More
Arrow Right

Quality Assurance, Monitoring & Testing Senior Manager, Vice President

The Wealth Products and Operations Control Testing Team is responsible for the t...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
https://www.citi.com/ Logo
Citi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 6-10 years of experience in operational risk management, compliance, audit, or other control-related functions in the financial services industry
  • Subject matter expert on controls design, execution and/or control testing
  • Excellent understanding of MCA (Managers Control Assessment) frameworks and processes
  • Advanced skills in MS Word, MS Excel, MS PowerPoint, and MS SharePoint
  • Effective communication, written and presentation skills
  • Strong people and relationship management skills with the ability to influence others and foster a sense of collaboration
  • Independent thinker and able to perform a credible challenge of businesses/functions
  • Ability to work effectively on virtual teams, including across different geographies and time zones preferred
  • Investment securities and/or insurance licenses preferred (e.g., Series 7, 9,10, 24, 63, 53, 55, 66, L&H)
  • Bachelor’s/University degree, Master’s degree preferred
Job Responsibility
Job Responsibility
  • Support the Controls Testing Utility by acting on assessing control design, designing control testing tools, developing control testing procedures, ensure control testing transitions, dispositioning exceptions, and developing insights
  • Carry key responsibility for Control Design Assessment (CDA) by executing CDA checklist/procedures for controls and recording results in Citi Risk & Control (CRC)
  • Own significant portions of control testing design activity, which includes writing control testing tool descriptions, and completing control testing and QUEST setup
  • Develop control testing procedures in Confluence and is responsible for obtaining necessary signoffs from covered businesses and functions
  • Perform a uniquely significant role on training Central Execution team overseas on all designed control testing tools and established control testing procedures
  • Has the ultimate decision on controls testing outlier disputes, holds the responsibility to raise concerns through IMPACT Concerns or QUEST Observation Logs based on the Business
  • Create materials for Operational Risk Forums (ORF) and senior meetings as needed and investigates causes for results that are deviating from trends and escalate situations that pose excessive risk(s)
  • Develop and drive quality-checking routines to ensure compliance with all relevant policies, operating guides, and owned control testing
  • Support team members on topics ranging from control testing design to performance management and control testing platforms basics
  • Help drive continuous improvements in accuracy, efficiency, timeliness, and quality of MCA control design assessment and controls testing
What we offer
What we offer
  • Citi provides programs and services for your physical and mental well-being including access to telehealth options, health advocates, confidential counseling and more
  • We believe all parents deserve time to adjust to parenthood and bond with the newest members of their families. That’s why in early 2020 we began rolling out our expanded Paid Parental Leave Policy to include Citi employees around the world
  • We empower our employees to manage their financial well-being and help them plan for the future
  • Citi provides access to an array of learning and development resources to help broaden and deepen your skills and knowledge as your career progresses
  • We have a variety of programs that help employees balance their work and life, including generous paid time off packages
  • We offer our employees resources and tools to volunteer in the communities in which they live and work
  • Fulltime
Read More
Arrow Right

Senior Food Safety and Quality Assurance Manager

We are seeking a highly specialized, results-driven Senior Food Safety & Quality...
Location
Location
United States
Salary
Salary:
90000.00 - 140000.00 USD / Year
afvusa.com Logo
American Food & Vending
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in food science, Public Health, Environmental Health, or a related field
  • Advanced degree and/or professional certifications preferred
  • Experience within the dining and refreshment sector (casual dining, quick-service, catering, events, or hospitality)
  • Lead Auditor certifications (ISO 22000, HACCP, SQF) or extensive internal auditing experience
  • Strong supplier quality management and vendor qualification experience
  • Knowledge of sanitation validation, environmental monitoring, and comprehensive allergen control programs
  • Familiarity with ERP systems and QA data integration beyond Salesforce
  • Experience supporting complex supply chains, international operations, or multi-brand portfolios
  • Demonstrated, hands-on experience with FDA, HACCP, SQF, DOT, NFPA, OSHA, and GMP requirements
  • Proven ability to interpret regulations and apply them to complex, multi-site operations
Job Responsibility
Job Responsibility
  • Design, implement, and maintain comprehensive food safety and quality assurance programs across multi-site dining and refreshment operations
  • Ensure compliance with applicable regulations and standards, including FDA (FSMA, GMPs, recalls, labeling), HACCP, SQF, DOT, NFPA, OSHA, and GMPs
  • Lead the development, validation, and optimization of HACCP plans, prerequisite programs (PRPs), sanitation programs, allergen control plans, and environmental monitoring programs where applicable
  • Maintain robust documentation control, versioning, and recordkeeping systems to support FDA, SQF, and GMP compliance, including change control and regulatory reviews
  • Conduct internal audits, supplier audits, third-party assessments, and mock recalls
  • Lead regulatory due diligence, risk assessments, gap analyses, CAPA development, remediation activities, and effectiveness verification through revalidation and follow-up audits
  • Oversee recall readiness, crisis management protocols, mock recalls, and business continuity planning
  • Monitor evolving regulatory requirements (FDA, OSHA, DOT, NFPA) and translate updates into actionable program enhancements
  • Lead food safety and occupational safety incident investigations, including root-cause analysis, containment, corrective and preventive actions, and verification activities
  • Promote a proactive food safety and workplace safety culture through continuous improvement initiatives and cross-functional engagement
What we offer
What we offer
  • Weekly Pay
  • 401K with match
  • Employee Assistance Program
  • Eligible employees offered Medical, Prescription, Dental, and Vision Plans
  • Learning and advancement opportunities
  • Fulltime
Read More
Arrow Right