All,
Apologies for the posting of a commercial nature.
I am currently recruiting for a Senior Complaince Manager in the Cambridge or London area. This is a highly presigious company specialising in biotechnology.
Ideally the individual will be a records management professional who has worked in the Pharmaceutical/Drug Industry and has an understanding of how records management works in FDA/MHRA/EMEA regulated companies.
Job Description
Job Responsibilities
Accountable for the day-to-day execution of the Enterprise Records & Information Management (ERIM) strategy
Contributes and develops ERIM standards
Independently determines approach to managing daily operations guided by general policies and management guidance
Interprets and executes policies that directly affect work activities
Develops and communicates plans/objectives to others
Initiate new or revised procedures, programs and initiatives
Influence and/or develop broad programs and initiatives
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 fulfil e-discovery and records information management tasks
Ability to interact and build relationships at all levels and across organizational boundaries
Experience developing standards around which others will operate
Lead the design and development of global processes, tools, and standards
Demonstrated experience and knowledge of continuous improvement methodologies
Proficiency in records management systems including retention schedules and record lifecycle management
Knowledge of FDA, EMEA, and other international regulations for GxP records
Basic Qualifications:
Bachelors degree (business, technology, records management preferred) from a US nationally accredited ranked college or university (or EU equivalent) or equivalent combination of education and experience with proven relevant work experience in records and information management
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
If this is of potential interest to yourself or anyone you know please feel free to contact me on [log in to unmask] or call +44 (0)207 922 7146. Also feel free to LinkIn with me at http://uk.linkedin.com/in/davidnixonregulatoryaffairs
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