The Director is responsible for advancing GxP compliance across Amgen’s Operations. They will lead all aspects of the internal quality audit group to ensure sites and functional teams operate in compliance with global quality standards and with regulatory requirements. In addition, they will play a leading role in creating awareness of emerging regulatory trends throughout the organization.  

Responsibilities: 

• Oversee performance and delivery of quality commitments in alignment with Quality strategies and with focus on continuous improvement 

• Develop and implement risk management processes for identifying and prioritizing areas of compliance risk and allocating appropriate resources to administer that risk 

• Set Operations audit schedule based on risk considerations and leads team in charge of executing internal audits 

• Proactively identify and alert the organization of quality or compliance concerns in time to resolve adverse impact to the patient and company reputation 

• Provide guidance as necessary to ensure compliance with relevant regulations and requirements worldwide 

• Serve as a member of the review team in charge for assessing potentially reportable deviations. In this capacity provides advice with respect to quality compliance and reporting regulatory requirements 

• Lead the development and implementation of measures to drive continuous improvement 

• Provide guidance and support for domestic and international Regulatory Authority Inspections  

• Advise on robust remediation and resolution of deficiencies identified through internal audits, inspections and otherwise; follows up on closure of corrective and preventive action plans 

• Implement metrics indicating the health of the audits and inspections process 

• Alert senior management of significant quality and compliance risks 

• Ensure that Quality Compliance personnel are qualified and trained to perform assigned functions in accordance with regulatory requirements 

• Coach and work with staff to establish career development plans. Partners with Human Resources to recruit, develop, retain and motivate outstanding staff 

• Develop area budget, manage expenditure and search for productivity opportunities 

• Attend trade association forums to provide input and gather information relevant to GxP compliance 

Win 

What we expect of you 

Basic Qualifications: 

And 

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources 

We are all different, yet we all use our unique contributions to serve patients. The Compliance professional we seek has these qualifications.  

• 10+ years’ experience Compliance, Quality in medical device/combination products/pharmaceutical/biotech industry 

• Excellent working knowledge of US and worldwide regulations pertaining to GxP regulations of the global medical device, pharmaceutical and biotechnology industries 

• Ability to build strong relationships to foster a collaborative approach to proactive compliance activities 

• Extensive experience with auditing, preparing reports based of audits data analysis 

• Ability to prioritize multiple priorities, projects, and team members, as well as adapt to changing business needs 

• Proven communication skills; teamwork and negotiation skills; ability to work through conflicting situations 

• Excellent technical writing skills 

Thrive 

What you can expect of us 

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.  

• Vast opportunities to learn and move up and across our global organization 

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act 

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits 

Apply now