Posted January 22, 2010 

Compliance Director, Enterprise Records and Information Managements

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 25 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.

Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

Amgen’s Worldwide Compliance and Business Ethics department intends to build a highly qualified and motivated team of professionals who will bring high levels of integrity, respect, experience, talent, perseverance, intelligence, creativity, energy and passion to become effective contributors within the company.  Our goal is to position the company as a national leader in the field of Compliance within the pharmaceutical industry.

 

In the highly critical and visible, Compliance Director, Enterprise Records and Information Management role, you will:

 

·         Translate business strategy to achievable, well defined objectives

·         Be accountable for the administration and results of the Enterprise Records and Information Management Compliance Platform

·         Lead the design and development of global processes, tools, and standards

·         Initiate new or revised procedures, programs and initiatives

·         Influence and/or develop broad programs and initiatives

·         Develop standards around which others will operate

·         Accomplish results through the direct management of a team and matrix resource

·         Develop and be accountable for administering budgets, schedules, objectives and goals

·         Work independently to determine approach to managing teams and daily operations

 

Knowledge/Competencies Leveraged 

 

• Comprehensive understanding of and the applicable regulations/laws that govern management of business records and information
• Knowledge and application of records and information management principles, processes and technologies for physical and electronic media
• Familiarity with establishing and utilizing technology to fulfill e-discovery and records information management tasks
• Ability to interact and build relationships at all levels and across organizational boundaries
• Demonstrated ability to set organizational direction and implement change
• Demonstrated experience and knowledge of continuous improvement methodologies
• Proficiency in anticipating and resolving problems
• Knowledge of GxP
• Proficiency in records management systems including retention schedules and record lifecycle management
• Knowledge of FDA, EMEA, and other international regulations for GxP records
• Skilled in building relationships and communications

Basic Qualifications:

 

• Bachelors with 10+ years of work experience in a regulated environment
• Prior experience in business records management, preferably in the pharmaceutical industry
• Experience managing technology spend and prioritization

• 8+ years experience developing and managing direct reports
• 7+ years experience working in an international, matrix organization
• Experience leading during time of change

 

Preferred Qualifications

 

• Advanced degree
• Certified Records Management (or equivalent)
• Previous experience in management of projects of moderate to high complexity
• Experience with databases and reporting tools

 

Location:              Amgen’s R&D Headquarters, in Thousand Oaks, CA

Relocation:          Yes

 

 Interested candidates, please email resume to smaguire@amgen.com