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.
This opportunity can either be hybrid (part-time on campus) from our Cambridge office or fully remote.
About This Role
The Senior Manager, BPE, is responsible for process document management (PDM), including the processes and systems used to manage process. Process management includes ownership, documentation, monitoring, and improvement. This role provides tactical leadership within the BPE team, helping to lead team meetings and providing input to and mentoring other team members. The role contributes to team strategy development and drives its implementation. This role oversees process document management (PDM) systems such as the Electronic Document Management System (EDMS) and the BPE SharePoint sites, as well as PDM processes. This role is responsible for creation, quality control checking (QCing), and processing SOPs, JAs, Forms, Templates, and other types of process documents, consulting with document owners to guide them through the process, and ensuring all steps are being followed. This role may manage one or more employees and will coordinate the work of contractor/FSP staff. This role leads and participates in special projects to support R&D business process management. There is an opportunity for this role to spend some of their time providing Continuous Improvement (CI) support for R&D if they possess Lean Six Sigma credentials and CI experience.
What You’ll Do
- Creation, quality control checking (QCing), and processing SOPs, JAs, Forms, Templates, and other types of process documents, consulting with document owners
- Owns one or more departmental processes
- Provides leadership and mentorship to other team members, giving input into process development and system oversight.
- Manages one or more employees or FSP/Contractor staff as required.
- Supports systems such as the Electronic Document Management System (EDMS) and BPE SharePoint sites
- Leads special projects as needed to support business process management
- May lead or support CI initiatives across R&D
Who You Are
You love the idea of being able to help every function across R&D to manage and improve the processes that allow us to get lifesaving medicines to patients in this highly regulated industry. You thrive in a fast-paced environment, requiring you to juggle multiple varied tasks and learn new technologies.
- 7+ years relevant work experience, ideally in the biotech / pharmaceutical industry
- Working knowledge of Good Practice Standards (GxP) with an emphasis on GCP and GVP
- Experience with technical writing for SOPs, job aids, forms and templates
- Knowledge of good documentation principles
- Thorough knowledge of Process Document Management (PDM) in the biotech / pharmaceutical industry
- Sound project management and organizational skills
- Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills, preferably to include experience in influencing and negotiation
- Experience in managing virtual teams within different regions and cultures.
- Continuous Improvement (CI) expertise (Lean Six Sigma Green Belt preferred)
- Experience with tracking process performance, monitoring processes using dashboards and technologies
The Sr. Manager, BPE position 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 requests by global partners off hours. Candidates with previous experience managing across US Eastern and European time zones are strongly preferred.
All your information will be kept confidential according to EEO guidelines.
To apply for this job please visit jobs.smartrecruiters.com.