Supervisor de Producción
ESA - Electronic Security Association
Senior Manager, Manufacturing – Deviation Investigations
Amgen
full-time
Posted on:
Location Type: Office
Location: Holly Springs • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $142,408 - $172,789 per year
Job Level
Senior
About the role
- Provide strategic and operational leadership for the Investigations function at ANC
- Oversee a team of Level 5 Investigators and ensure investigations meet regulatory and quality expectations
- Lead the Major Investigation Writing Team responsible for high-complexity deviation investigations within ANC’s Drug Substance Flex Batch Manufacturing operations
- Provide direct management, coaching, and development to Level 5 investigators, fostering strong technical writing, problem-solving, and critical thinking skills
- Ensure investigation quality and consistency, overseeing documentation for accuracy, compliance, and readiness for regulatory inspection
- Establish best practices, standardized processes, and metrics to continuously improve the deviation investigation system
- Serve as the point of contact for escalation of critical investigations and communicate investigation outcomes to site and global leadership
- Present investigations and findings to regulatory inspectors, internal auditors, and senior leadership
- Partner cross-functionally with Manufacturing, Quality, Engineering, Process Development, Analytical Sciences, Supply Chain, and Regulatory Affairs
- Influence site-wide decision-making on deviation management strategies and corrective/preventative actions (CAPAs)
- Drive strategic projects to enhance efficiency, knowledge sharing, and compliance in deviation investigation processes
Requirements
- High school diploma / GED & 12 years Quality and/or Manufacturing experience
- Associate’s degree & 10 years of Quality and/or Manufacturing experience
- Bachelor’s degree & 8 years of Quality and/or Manufacturing experience
- Master’s degree & 6 years of Quality and/or Manufacturing experience
- Doctorate degree & 2 years of Quality and/or Manufacturing experience
- 8+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Prior people leadership experience, managing and developing a team of investigators or equivalent technical staff
- Strong background in compliance, root cause analysis, problem-solving, and CAPA management
- Experience using Quality Management Systems (e.g., Veeva, TrackWise) for deviation investigations
- Proven track record of leading teams through regulatory inspections and audits
- Excellent organizational skills, with ability to manage multiple priorities and deadlines in a fast-paced environment
- Exceptional written and verbal communication skills with the ability to influence at all organizational levels
- Strong interpersonal skills and demonstrated success in cross-functional collaboration
Benefits
- In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
- Support for professional and personal growth and well-being; collaborative culture.
- Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
deviation investigationsroot cause analysisCAPA managementquality assuranceprocess developmentregulatory compliancetechnical writingproblem-solvinginvestigation qualitymetrics establishment
Soft skills
leadershipcoachingcritical thinkingorganizational skillscommunicationinterpersonal skillscross-functional collaborationinfluencingtime managementteam development
