VIVA USA Inc Project Manager in Marlborough, Massachusetts
Req Ref No: SRMAIP7 Location: Marlborough, MA Duration: 8.0 months
We are looking for an experienced Project Manager (PM) to drive execution of product care and sustaining engineering projects. The PM leads projects ensuring proper execution to deliver results on-time, accurate reporting and resource allocation. The PM will be working within a cross-functional multidisciplinary team spanning over multiple global sites.
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, and resources/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
Quality Specific Goals:
• 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
• Bachelor’s 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
Preferred Qualifications: • 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
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.