External Posting TitleSr. Manager, Quality Risk Management - R&D ComplianceJob DescriptionSupports and/or leads R&D Quality Risk Management (QRM) initiatives and serves as a Research & Development Quality and Compliance (RDQC) resource for compliance or quality issues that impact R&D functions. This includes partnering with Quality and Compliance organizations across R&D and throughout the Biogen organization. This role will provide expertise and guidance related to relevant and current GxP (GCP, GLP, GVP) regulations and guidelines as well as those non-GxP compliance guidelines that impact R&D functions enabling transparency and escalation of R&D quality and compliance issues. It is expected that this role provide expertise in the following areas:
* CAPA prioritization, development and execution as pertains to major and critical audit or inspection findings and quality issues requiring CAPA
* Develop and evaluate relevant metrics
* Proactively assess potential risks and recommend mitigations/remediations to relevant R&D staff
* Understanding when and providing guidance on how to escalate quality issues and acts as point of escalation of identified risks to governance boards and senior leadership
* Risk evaluation and consultation on quality and compliance issues
* Lead inspection readiness and inspection management activities
1.Provides strategic direction and advisement to functional quality representatives (FQRs) and Process Owner Network (PON) to support ongoing implementation and maintenance of R&D QMS
2.Provides instruction and consultation on the use of risk assessment and process improvement methodologies
3.May serve as the GxP inspection lead providing strategic guidance and or/oversight of planning, conduct, close-out of inspections as well as post-inspection responses.
4. Serves as key cross functional decision maker regarding compliance/quality risk management/ mitigation prioritization associated with regulatory inspection planning and execution
5.Drives execution of R&D GxP quality and/or compliance initiatives that have cross-functional R&D impact or as it relates to a critical compliance issues.
6.Provide support, leadership, coordination, direction, advisement and/or oversight in the implementation of new and existing GxP requirements in R&D.
7.Support and/or lead GCP serious breach assessments.
8.Supports process owners in designing and implementing relevant RDQC processes and procedures including metrics, thresholds, and continuous improvement initiatives
9.Serves as ad hoc Chair for Quality Council (QC) and as such determines agenda items for discussion and escalation to Quality and Compliance Executive Committee (QCEC) Chair.
10.Serves as coordinator for QCEC meetings
11.Provides direction and leadership to direct reports and mentorship to more junior level staff in RDQC.LocationCambridge, MA, USJob CategoryQualityRequisition Number31683BRQualifications
* 2 - 4 years pharmaceutical or biotechnology drug development experience
* 1-2 years in a quality or compliance related discipline or equivalent quality management activities
* Basic knowledge of international GxP drug development regulations, including USA (FDA), EU (EMA, MHRA), Japan (PMDA), and ICH Guidelines
* Strong analytical skills, ability to perform quantitative analyses, derive insights and implications
* Excellent communication skills, verbal, written and presenting in English
* Working knowledge of MS Word, Excel, PowerPoint, SharePoint, Outlook, and audit management systems
* Ability to management multiple project simultaneously, prioritize workload for teams and function in fast paced environment
* Prior project management experience is a plusEducation
* Bachelor's degree required, Masters in Regulatory Science, Regulatory Compliance, or Drug Development preferredAbout BiogenCorporate 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.
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 "" email accounts.