Associate Director, R&D Quality and Compliance (Research and Biotherapeutic and Medicinal Sciences)
Company: Biogen
Location: Cambridge
Posted on: June 22, 2022
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Job Description:
Job Description
About This Role:
As the Associate Director, R&D Quality and Compliance you play
an essential role within Biogen's quality team. In this role you
provide expertise and leadership for GxP and non-GxP compliance and
quality activities specifically within the Research and
Biotherapeutic and Medicinal Sciences (BTMS) functions. You will
also be responsible for driving a culture of quality and overseeing
compliance within the functions and will serve as an advocate for
the Quality Management System (QMS). As a Functional Quality
Representative (FQR), you will liaise with the R&D Quality and
Compliance team and FQRs from other R&D functions and operate
within the defined quality governance structure.
This role will report to the Head, R&D Quality Culture, Process
and Systems with a dotted reporting line to the Head, Translational
Biology.
What You'll Do
Drive a culture of quality within the Research and Biotherapeutic
and Medicinal Sciences (BTMS) departments
Provide quality support to the Research and BTMS departments with
activities such as audits, inspections, vendor management, and
CAPAs.
Assess risks and issues and guide staff to take a risk-based
approach to quality
Who You Are
You are passionate about Quality and enjoy educating and helping
teams to see the value it brings to their work.
Qualifications
Required Skills:
Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is
a unique focus within our industry and this shared purpose is what
connects us as a team. We work together to overcome obstacles and
to follow the science. We are resilient as we strive to make an
impact on our patients' lives and on changing the course of
medicine. Together, we pioneer. Together, we thrive.
Keywords: Biogen, Cambridge , Associate Director, R&D Quality and Compliance (Research and Biotherapeutic and Medicinal Sciences), Executive , Cambridge, Massachusetts
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