Hiring Organization
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EMPLOYER ID: BIO
COMPANY URL: http://www.biogenidec.com/careers
COMPANY NAME: Biogen Idec
COMPANY PROFILE:
About Biogen Idec: Transforming Discovery into Care
With operations across the
Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is
one of the world's leading biotechnology companies,
creating new standards of care in oncology, neurology,
and immunology. Every day, employees of Biogen Idec make
a difference in people's lives, through pioneering
research and development, manufacturing, and our
worldwide commercial capabilities.
Biogen Idec is proud to be
an equal opportunity employer
CONTACT INFORMATION:
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NAME: Garry Russell
POSITION: Recruiting Partner
COUNTRY CODE: US
POSTAL CODE:
REGION: MA
MUNICIPALITY: Cambridge
ADDRESS:
PHONE: 508-898-9004
FAX:
EMAIL: R9526236809353@posttrak.arbita.net
JOB POSTING INFORMATION
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JOB TITLE: IT Quality Director
SSONETCODE: 1100050
JOB CATEGORY: Management
JOB AREA:
FUNCTION CODE: INF
INDUSTRY CODE: OTH
JOB STATUS: Full Time
COUNTRY: US
POSTAL CODE: 02493
REGION: MA
MUNICIPALITY: Weston
SALARY LEVEL: Salary commensurate with experience
BENEFITS:
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JOB DESCRIPTION:
As the Head of Quality IT,
this person will be responsible for creating and
implementing an IT Quality Program Strategy. This
ensures compliance with all applicable regulations
including but not limited to, FDA, EMEA, Sarbanes Oxley,
etc. This person is responsible for the overall success
of the IT Quality Organization. The person represents
Biogen Idec to the FDA and other external and internal
auditing agencies. Continuously assesses risk and advises
management accordingly. In addition, Manages the IT
Quality Staff and contractors.
Responssibilities:
1.Develop and implement an IT Quality Program Strategy
which ensures compliance with all applicable regulations
including, but not limited to, FDA, EMEA, Sarbanes Oxley,
etc. Build measurable metrics and report monthly status
to the IT Management and to Global Quality oversight.
Continuously assess risk and advise management
accordingly.
2.Represent Biogen Idec IT to the FDA, other external and
internal auditing agencies. Formulate and coordinate
audit response and commitments to the auditors as
applicable on behalf of IT Management.
3.Influence the strategic direction and overall
management of the IT organization.
4. Develop an IT Staff Training program to demonstrate
competency on the job with curricula assignments,
training materials and delivery, and measurement.
5.Provide technical expertise and recommendations to the
CIO, IT Board, and as appropriate to others in the
company on day-to-day quality and compliance issues.
6. Manage the IT Quality Staff and contractors.
7. Continuously be up-to-date on latest industry
regulations and ensure they are implemented accordingly
and promptly.
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QUALIFICATIONS: Should
have at least 10 years total IT experience in the
pharmaceutical industry with minimum 5 years in Quality
Management role.
Candidates must have hands-on IT experience an intimate
knowledge of all FDA regulations and Sarbanes Oxley.
