Job Details

Sr. Director, R&D Quality Risk Management

Company name
Biogen

Location
Cambridge, MA

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Provides global strategic leadership for R&D Quality Risk Management (QRM), sets vision for team in alignment with R&D Quality and Compliance (RDQC) vision and manages broad cross-functional change for Research and Development; Manages workload and resources for the QRM; Enables use of GCP, GLP, and GVP expertise to make risk-based decisions and action plans for quality & compliance issues across R&D using trend analysis. Serves as a point for escalation of identified risks to governance boards & Sr. Management. Develops and manages framework for R&D Quality Management System (QMS); Provides risk evaluation and consultation on compliance issues (includes GCP, GLP, & GVP or non-GXP) with senior leadership. Partners with Quality and Compliance organizations across Biogen to enable transparency & escalation of R&D quality and compliance issues as well as supports non GXP quality and compliance efforts that impact R&D. Manages team budget and associated contracts, purchase orders and invoices. May also lead in inspection readiness and inspection management activities as well as the development of associated processes to enable R&D to be in a steady state of inspection readiness.

Principal Accountabilities include:

1. Develop, build and manages framework for the R&D quality Management system, inclusive of policies and internal standards

2. Provides leadership & Management of people for the QRM team, cascading messages and goals from Sr. Management and escalates proposals for direction, and issues & risks escalations to Sr. Management

3. Manages and advises on critical compliance issues. Evaluates and provides risk assessment to senior leadership on critical R&D activities on an as needed basis, including before, during and after inspections, as needed

4. Leads/Drives key R&D compliance or quality related initiatives, and provide strategic guidance to teams for ongoing initiatives

5. Participates in or may lead quality related steering committees to provide oversight of quality and compliance issues across R&D (including quality oversight of vendors). Represent R&D quality on company-wide compliance and quality forums

5. Identifies, approves and serves as the process owner / provides oversight of the design and implementation of relevant processes and procedures, including metrics, thresholds, continuous improvement initiatives

7. Co-leads the establishment of the overall R&D inspection strategy and facilitates inspection planning across R&D function as well as enables ongoing efforts to maintain a steady state of inspection readiness. Engaging senior leadership as necessary to enable execution of the plan Location US-MA-Cambridge Job Category Quality Requisition Number 32485BR Qualifications • 10-12 years pharmaceutical or biotechnology drug development experience

• 8 years global GCP, GLP and/or GVP QA or Compliance experience

• 8 years of people management experience (including senior level positions)

• Demonstrated experience with building a quality management system or equivalent cross-functional project/system Education Bachelor's Degree required, Masters/PhD optional - Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred About Biogen Corporate Overview

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.

Our Science

We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.

For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer's disease, Parkinson's disease, and ALS. As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.

Biogen is revolutionizing biologics manufacturing, developing the industry's most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.

Our Corporate Citizenship

The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek's 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science's list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Please be advised that all legitimate correspondence from a Biogen employee will come from @biogen.com email accounts.

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Company info

Biogen
Website : https://www.biogen.com

Company Profile
Biogen Idec Inc. discovers, develops, manufactures, and markets therapies for the treatment of neurodegenerative diseases, hemophilia, and autoimmune disorders in the United States and internationally. Its marketed products include AVONEX for the treatment of relapsing multiple sclerosis (MS); TYSABRI to treat relapsing MS; RITUXAN for treating relapsed or refractory, CD20-positive, and B-cell Non-Hodgkin’s lymphoma (NHL); FUMADERM for the treatment of severe plaque psoriasis in adult patients; and FAMPYRA, an oral compound for the improvement of walking in adult patients with MS with walking disability. The company’s products that completed Phase III clinical trials comprise TECFIDERA (BG-12) for MS; Peginterferon beta-1a to prolong the effects and reduce the dosing frequency of interferon beta-1a; and long-lasting Factor VIII and IX product candidates for the treatment of hemophilia. Its products under Phase III clinical trials consist of Daclizumab, a monoclonal antibody in relapsing MS; TYSABRI for secondary progressive MS; and GA101, a monoclonal antibody for chronic lymphocytic leukemia and NHL. The company’s Phase II clinical trial products include Anti-LINGO for optic neuritis; STX-100 for idiopathic pulmonary fibrosis; and ANTI-TWAEK for lupus nephritis. The company’s Phase I clinical trial products comprise Anti-LINGO for MS; BIIB037 for Alzheimer's disease; Neublastin for neuropathic pain; and Anti-CD40 Ligand for general lupus, as well as Phase 1b/2a clinical trial product includes ISIS-SMNRx for spinal muscular atrophy. It has collaboration agreements with Genentech, Inc.; Elan Pharma International, Ltd; Acorda Therapeutics, Inc.; Portola Pharmaceuticals, Inc.; and Swedish Orphan Biovitrum AB. The company was formerly known as IDEC Pharmaceuticals Corporation and changed its name to Biogen Idec Inc. in November 2003. Biogen Idec Inc. was founded in 1985 and is headquartered in Cambridge, Massachusetts.

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