About This Role

The successful candidate will be responsible for the leading the QA department and strategy under the R&D QMS. This includes business elements covering Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), Good Research Practice (GRP) and Good Pharmacovigilance Practice (GVP).

What You’ll Do

1. Provides global strategic leadership for the quality assurance of GxP (GLP, GCP, GVP and GRP) processes and functional areas (Clinical operations, Safety, Regulatory, Research, Nonclinical etc.) governed by the R&D QMS through a proactive identification and escalation of quality and GxP compliance risks

2.  Leads and oversees the operational execution of R&D Quality and Compliance GxP processes which includes audits, regulatory intelligence, inspection management, change control and quality risk management. 

3.  Supports strategic changes to the R&D Quality Management System to ensure compliance to GxPs and industry standards. Partners, consults or leads large cross-functional quality projects ensuring alignment to GxP regulations and R&D’s QMS. 

4.  Develps and maintains effective working relationships with individuals within and outside the company including senior leadership, vendors, quality teams, legal, corporate compliance, regulatory agencies/competant authorities to enable transparency of GxP risks, escalation and actions to resolve quality and compliance issues.

5. Provides expertise, interpretation and guidance related to relevant and current GxP regulations/guidelines to drive compliance across R&D QMS.

6. Chairs applicable quality governance forums and is responsible for escalation of quality and GxP compliance risks and issues to drive resolution.

7.  Actively manages a global team which includes organizational strategy, resource allocation, budget and management to HR requirements.

 Who You Are

We are looking for someone who is passionate about Quality, loves to learn, and enjoys collaborating with many different functions.

Required Skills

• Bachelor’s Degree; science, engineering or other technical are preferred.

·       At least 15 years pharmaceutical or biotechnology drug development experience;

·       10+ years in a quality or compliance related discipline or equivalent quality management activities;

·       10+ years GXP QA or Compliance experience, with strong GVP and/or GCP experience and experience in multiple disciplines.

·       10+ years people management experience

·       Demonstrated experience with a clinical QMS (Transcelerate model of the clinical QMS preferred) or PV QMS

·       Working knowledge of international GXP regulations and directives, including USA (FDA), EU (EMA), UK (MHRA), Japan (PMDA), China and ICH Guidelines.

The Sr Director, R&D Compliance is a global leadership position which includes managing teams and collaborating with key stakeholders across several time zones. Core business hours expected are 8am-5pm EST and may include ad-hoc urgent responses during audits or inspections being conducted by global partners off hours. Candidates with previous experience managing across US Eastern and European time zones are strongly preferred. 

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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.