Senior Specialist, Quality Compliance, External Affairs
Amgen
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $NaN per year
Job Level
About the role
- Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP)
- Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines.
- Ensure all pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a current state within Amgen systems.
- Author compendial assessments within Amgen’s documentation management systems for audit readiness purposes.
- Proactively monitor early signals, emerging trends, and evolving regulatory issues impacting global operations as it relates to pharmacopoeia matters.
- Represent Amgen’s approved positions in external organizations and trade associations as assigned, to influence and shape pharmacopeial public standards.
- Liaise with regulators through industry associations, supporting advocacy and alignment efforts.
- Partner with internal SMEs to ensure scientific alignment on pharmacopeial developments and regulatory changes.
- Support knowledge-sharing across functions to enhance understanding of external landscape developments.
- Provide back-up support within External Affairs as needed to ensure business continuity.
- Networking across various Amgen functions including Quality Control, Quality Assurance, Process Development/Attribute Sciences, Material Quality, Engineering, Product Quality, Microbiology, Toxicology, GRAAS-CMC and R&D Policy.
- Liaise with Governmental Affairs, Supply Chain, manufacturing / development sites, External Quality (CMO) and affiliates/IDQ, as appropriate
- Lead and contribute to continuous improvement initiatives to enhance efficiency and effectiveness of the pharmacopeial program.
Requirements
- Doctorate degree and 2 years of quality compliance experience OR Master’s degree and 4 years of quality compliance experience OR Bachelor’s degree and 6 years of quality compliance experience OR Associate’s degree and 10 years of quality compliance experience OR High school diploma / GED and 12 years of quality compliance experience
- Background in Quality, QC, QA, Engineering desirable.
- Understand quality documentation and laboratory practices including general methodologies, specifications and product quality standards.
- Excellent communication skills for both internal conversations and when representing Amgen at external forums
- Conflict resolution
- Teamwork and Networking
- Good organization, planning and prioritization capability
- Time management
- Attention to details.
Benefits
- 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
- flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality compliancequality documentationlaboratory practicespharmacopeial assessmentsaudit readinessregulatory issuescontinuous improvementproduct quality standardsproject managementscientific alignment
Soft Skills
communication skillsconflict resolutionteamworknetworkingorganizationplanningprioritizationtime managementattention to detail
Certifications
Doctorate degreeMaster’s degreeBachelor’s degreeAssociate’s degreeHigh school diploma / GED