The Compliance Ops Manager strengthens Amgen’s compliance culture by supporting implementation of Amgen’s Quality Management System and ensuring the ongoing management and improvement of compliance related information systems. The Compliance Ops Manager works closely with clients (in global, regional and local roles) within R&D as well as with partner organizations (including Law, Healthcare Compliance, & Manufacturing/Operations). The Compliance Ops Manager will support the ongoing implementation of Process Management, CAPA, and other key quality processes, capabilities, and systems.
Specific responsibilities may include:
• Primary BPMS (Business Process Management System) administrator and process developer, including change control lead.
• Functions as secondary process modeler, and will lead and facilitate modeling projects for clients
• Training clients and external modelers on BPMS systems usage
• Gathering requirements for future BPMS improvements and integration in accordance to the QMS vision
• Develop technical understanding of key Amgen systems for purposes of system improvements and cross-information sharing
• Provides information and systems analysis in support of the QMS vision for R&D
• Establish relationships with external QMS groups and QMS system owners
• Leads development of a robust quality systems information sharing platform and strategy.
• Aligns system improvement efforts across QMS
Master’s degree & 3 years of directly related experience
Bachelor’s degree & 5 years of directly related experience
Associate’s degree & 10 years of directly related experience
High school diploma / GED & 12 years of directly related experience
• Bachelor’s degree and 4+ years of professional experience in the healthcare/biopharmaceutical industry
• 2+ years experience in leading projects, including process mapping and creation of process-based documents
• Successful experience working on cross-functional teams
• Strong verbal and written communication skills, and analysis skills of any kind
•The ideal candidate has extensive systems analysis experience and can apply systemic analytical thinking to a variety of circumstances.
•Strong problem-solving skills desired.
•Experience building healthy working relationships across departments, solving problems, working under time constraints, presenting to internal peers and external clients, managing numerous projects at once, and leading teams.
•Willingness to learn new methodologies, tools, systems, and concepts as the situation demands, and guide external clients.
Amgen - 9 months ago
Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...