Job Description he Lead, Investigations oversees the responsibilities of the Investigations , Performance and Process Improvement groups; develops team members and career paths; implements best industry practices; leads and participates in projects; participates in cross-site teams; develops and implements improvements within the function. The incumbent will proactively engage and collaborate with cross-functional groups to continuously improve the investigation process and ensure on-time closure of investigations. The incumbent will demonstrate exceptional networking skills through interactions across departments and divisions.

　　What You’ll Do

　　Responsible for mentoring and development of Investigation team membersManagement of highly technical/visible cross functional projectsResponsible for assigned highly complex/visible Quality investigations at Biogen manufacturing sitesResponsible for sharing relevant investigation information from internal and external meetings with appropriate colleaguesCollaborates cross-functionally to ensure robust investigation conclusions, effective communication, and sharing of learningsWorks cross-functionally and across sites to maintain alignment on how processes and systems are improved as a result of investigative findings and/or risk analysesResponsible for technical leadership and guiding of professional staff.  Fully accountable for directing and coordinating activities related to Quality investigations to meet business, safety and reliability objectives within scope of team’s assignment.Reviews and approves investigation reports generated by his/her team.Confers with functional heads on all critical decisions, identification of issues and problem resolution to ensure concurrence and  operational impact, especially as related to high-risk investigations.Confers with team members on appropriate standards for investigation process.

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　　Who you are

　　You are a talented Biopharma expert in the investigation space, leading and developing teams to focus on deviation investigations, root cause analysis, and effective communication across all levels of the business. A keen eye for growth and improvement with a passion for developing your team and your own skills through collaboration, detail, and a strong background in technical writing

　　Qualifications  

　　Required skills

　　B.S. Degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline plus 5 years of transferrable experienceAssociates Degree and 7 years of transferrable ExperienceExperience in identification and management of diverse stakeholders with strong interpersonal/influencing skills. High level of personal credibility and relationship management. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.  Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniquesPractical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy.Ability to work with relevant electronic systems. Preferred Skills

　　Demonstrated experience in supervision, coaching and mentoring of personnelTraining or development of investigative techniques Demonstrated experience in performance improvement with basis in Human and Organizational Performance principles. 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.

　　At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

　　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.