Senior Specialist, Quality Compliance, External Affairs
Job Description:
• 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.
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• 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.
Apply tot his job
Apply To this Job