Location(s): United States; Massachusetts; Marlborough
About Us: What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world.
We are an $18 billion unit of General Electric Company (NYSE: GE), employing more than 52,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare.
Something remarkable happens when you bring together people who are committed to making a difference - they do!
GE Healthcare Life Sciences provides products and services used as tools for biopharmaceutical manufacturing, drug discovery and the latest in cellular technologies, thereby enabling our customers around the world to be more productive, effective and creative. Our motivation is to create better health for more people. Through our five decades of supporting the biopharmaceutical industry and its research partners to become more productive, we are helping to reduce costs, increase access and improve quality in the healthcare system. We use our expertise and know-how in imaginative ways to work with our customers to provide what’s needed today and create products and solutions to enable the medical treatments of tomorrow. We add value to our customers by:
Providing cutting-edge research tools that give deeper insights into cell function to enable disease diagnosis and the development of treatments.
Enabling manufacturing productivity: we provide solutions for the entire bioprocess workflow (i.e. start-to-finish bioprocessing) helping our customers to develop and manufacture biopharmaceuticals more efficiently.
Providing high quality support and maintenance services.
We are the home of many famous brands, including Whatman, Amersham, Biacore, WAVE, Applied Precision, Xcellerex and more.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: The Project Manager position is responsible for providing project management leadership to ongoing activities. In addition, this position is accountable for achieving quality objectives, meeting development schedules, and effective team execution, as well as communicating program status and escalating issues when appropriate to facilitate project delivery.
Essential Responsibilities: • Leading and managing new product development quality and execution for cell therapy and other projects • Managing budgets for ongoing projects under program activities • Working closely with all cross-functional groups in delivering effective new product development process results • Coordinating and scheduling cross-functional program activities for the cell therapy product development teams. • Ensuring compliance with Design History File (DHF) and other QMS requirements • Managing quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives
Qualifications/Requirements: Qualifications: 1. BS Degree in an engineering, physical or biological science or equivalent (defined as a High School Diploma/GED and 4 years relevant work experience) 2. 4 years relevant project management experience 3. Demonstrated leadership of cross-functional project teams and an ability to drive project design plans to completion 4. Familiarity with ISO, FDA and other regulatory standards
Quality Specific Goals: 1. Comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Ensure compliance/closure of Regulatory and Quality requirements before approving design control reviews and product development program milestones 5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Desired Characteristics: 1. Strong written and verbal communication skills 2. PMP or equivalent certification 3. Experience with a milestone-driven gated product development process 4. Experience with conflict resolution 5. 7 years of relevant project leadership experience 6. Experience with entire NPI cycle of GEHC products
Locations: United States; Massachusetts; Marlborough
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