Need Manufacturing Project Manager III (Pharma/medical/Biotech Industry)

Need Manufacturing Project Manager III (Pharma/medical/Biotech Industry)

21 Apr 2024
Massachusetts, Marlborough, 01752 Marlborough USA

Need Manufacturing Project Manager III (Pharma/medical/Biotech Industry)

Vacancy expired!

Title : Project Manager III (Pharma/medical/Biotech Industry)
Location : Marlborough, MA
Role Summary/Purpose:
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.

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, 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

Qualifications/Requirements:
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

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