Sr. Specialist Manufacturing
Amgen
August 25, 2026
Remote friendly (West Greenwich, RI)
United States
Operations
Sr. Specialist Manufacturing
What You Will Do
- Provide technical leadership for complex major deviation investigations and drive science and risk-based decision making to advance operational excellence.
Key Responsibilities
- Serve as technical lead and Major Deviation Owner for the site’s most complex, high-impact, regulatory-significant investigations (initiation through closure).
- Lead in-field investigation activities, coach investigation teams, and drive rigorous fact-finding for high-quality, science- and risk-based outcomes.
- Act as a subject matter expert; mentor and share knowledge using advanced investigation methodologies.
- Partner with investigation leaders and quality organizations to standardize practices and implement enterprise best practices.
- Defend investigation strategy, rationale, and compliance decisions during internal audits, regulatory inspections, and health authority interactions.
- Lead continuous improvement initiatives, including evaluation/implementation/governance of AI-enabled investigation tools and digital solutions.
- Recommend risk-based solutions based on systemic trends to strengthen product quality and regulatory compliance.
- Lead complex cross-functional problem-solving (Manufacturing, Engineering, Process Development, QC, Supply Chain, Regulatory Affairs).
- Use data analytics, quality metrics, and emerging technologies to proactively identify risks and optimize investigations.
Basic Qualifications
- High school/GED + 12 yrs Quality and/or Manufacturing OR Associate’s + 10 yrs OR Bachelor’s + 6 yrs OR Master’s + 4 yrs OR Doctorate + 2 yrs.
Preferred Qualifications
- GMP deviation management, root cause investigations, CAPA strategy, and quality systems.
- Experience representing organization in internal audits/regulatory inspections.
- Proven ability to lead complex cross-functional projects and manage multiple priorities.
- Strong written/verbal/presentation skills; stakeholder influence.
- Ability to build trusted partnerships without formal authority.
Benefits (Total Rewards)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field sales), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications continue until sufficient candidates are received or a candidate is selected.
What You Will Do
- Provide technical leadership for complex major deviation investigations and drive science and risk-based decision making to advance operational excellence.
Key Responsibilities
- Serve as technical lead and Major Deviation Owner for the site’s most complex, high-impact, regulatory-significant investigations (initiation through closure).
- Lead in-field investigation activities, coach investigation teams, and drive rigorous fact-finding for high-quality, science- and risk-based outcomes.
- Act as a subject matter expert; mentor and share knowledge using advanced investigation methodologies.
- Partner with investigation leaders and quality organizations to standardize practices and implement enterprise best practices.
- Defend investigation strategy, rationale, and compliance decisions during internal audits, regulatory inspections, and health authority interactions.
- Lead continuous improvement initiatives, including evaluation/implementation/governance of AI-enabled investigation tools and digital solutions.
- Recommend risk-based solutions based on systemic trends to strengthen product quality and regulatory compliance.
- Lead complex cross-functional problem-solving (Manufacturing, Engineering, Process Development, QC, Supply Chain, Regulatory Affairs).
- Use data analytics, quality metrics, and emerging technologies to proactively identify risks and optimize investigations.
Basic Qualifications
- High school/GED + 12 yrs Quality and/or Manufacturing OR Associate’s + 10 yrs OR Bachelor’s + 6 yrs OR Master’s + 4 yrs OR Doctorate + 2 yrs.
Preferred Qualifications
- GMP deviation management, root cause investigations, CAPA strategy, and quality systems.
- Experience representing organization in internal audits/regulatory inspections.
- Proven ability to lead complex cross-functional projects and manage multiple priorities.
- Strong written/verbal/presentation skills; stakeholder influence.
- Ability to build trusted partnerships without formal authority.
Benefits (Total Rewards)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field sales), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications continue until sufficient candidates are received or a candidate is selected.