Vacancy expired!
Project ManagerGlobal Life Sciences FirmMarlborough, MALong Term ContractRole Summary/Purpose:We are looking for an experienced Project Manager (PM) to drive execution of product care andsustaining engineering projects. The PM leads projects ensuring proper execution to deliver resultson-time, accurate reporting and resource allocation. The PM will be working within a cross-functionalmultidisciplinary team spanning over multiple global sites.Essential Responsibilities:This is an excellent opportunity to work in the dynamic and fast-growing Cell and Gene Therapy (CGT)space with global, cross-functional team.
- Project planning, specification and driving projects to completion
- Reporting and tracking project resources and budget allocation
- Leading cross-functional program activities for Cell and Gene Therapy projects responsibility for timely completion within budget
- Working closely with Product Management team to drive product direction and resolve issues
- Managing and optimizing project plans, product/project risk, project budgets, andresources/task assignments
- Liaising with and working with Suppliers and our CMOs to ensure seamless production and
- maintenance of quality
- Effectively facilitating cross-functional decision making to deliver effective and timely
- improvements to existing products and processes
- Ensuring compliance with Design History File (DHF) and other QMS requirements
- Managing customer critical-to-quality (CTQ) objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives
- Provide periodic stakeholder communications and escalating concerns and issues as necessary
- Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
- Complete all planned Quality & Compliance training within the defined deadlines.
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Bachelors Degree in Mechanical, Biology, Biomedical Engineering, or related Engineering/ Science discipline 5+ years project leadership/management experience within product development, sustaining, manufacturing, or a research environment
- Demonstrated execution at meeting project goals while satisfying quality, performance, schedule, and budget requirements
- Demonstrated engineering knowledge, program management, and business planning processes, with the full product lifecycle management experience
- Familiarity with ISO, FDA and/or other regulatory standards
- Strong verbal and written communication skills
- Demonstrated analytical and problem-solving skills
- Experience in regulated industries highly desirable, preferably in Healthcare, Life Sciences.
- Fast learner, willingness to adapt to and adopt new tools.
- Ability to influence cross functional decision makers
- Demonstrated LEAN skills and working knowledge of Agile methodology
- In-depth understanding of ISO 9001 and/or ISO 13485 based QMS
Vacancy expired!