Quality Technical Product Manager, Pharmaceutical Diagnostics
Quality Technical Product Manager, Pharmaceutical Diagnostics
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Job Description
Job Description Summary
Are you ready to make a significant impact in the world of Pharmaceutical Diagnostics (PDx). Join our dynamic IT team as a Quality Technical Product Manager!In this pivotal role you will collaborate closely with our Quality colleagues to shape strategic digitization priorities develop a robust portfolio of investments and create compelling business cases. Your expertise will be crucial in crafting detailed business requirements for approved investments and overseeing the delivery of key projects and products including LIMS Chromatography systems Environmental Monitoring system Quality Management system. This role ensures that all Quality IT systems are compliant with regulatory guidelines and drive continuous improvement in Quality processes.
You will help implement technology solutions in a cost-effective way by determining the requirements of a project or program in alignment with strategic roadmap that helps achieve business objectives.
Job Description
Responsibilities
Implement and maintain IT systems and software for the Quality department to ensure compliance with regulatory standards (e.g. FDA EMA ICH).
Manage the investigation and resolution of IT-related issues including system non-conformances and deviations. Lead investigation and troubleshooting on critical Lab application issues and coordinate with different teams to get desired results.
Adept at requirements gathering & analysis through leading business process review sessions and stakeholder interviews.
Translate unstructured or ambiguous requests into actionable requirements through problem decomposition and planning.
Ability to map As-Is process based on inputs from business SMEs and help establish the future process state
Prioritize continuously in accordance with the understanding and validation of customer problems and needs.
Stay updated with industry trends and regulatory changes to ensure compliance and best practices.
Lead the implementation of new IT technologies and methodologies to enhance QC efficiency and accuracy.
Own the short-term product roadmap and its integration into a larger application or strategic roadmap.
Strong written and verbal communication skills.
Function as communication hub for business to collate requirements and coordinate & drive deliverables.
Demonstrates strong analytical and creative problem solving and prioritisation skills
Demonstrate practical experience in Business Analysis methodologies to run meetings & stand-ups relevant project documentation and change controls to collaborate with all stakeholders.
Qualifications and Requirements
A Bachelors Degree in Computer Science or STEM Majors (Science Technology Engineering and Math) or equivalent
Strong relevant professional experience in working in the Pharma or IT Industry including experience in the Digital Lab domain
Technical experience with Quality platforms such as but not limited to LIMS (Lab Information Management System) Chromatography systems (Chromeleon Empower) Environmental Monitoring Quality Management systems is Mandatory.
Expert understanding of analysis & design and system architecture concepts.
Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP) 21CFR Part 11 EU Annex 11.
Ability to execute in a technical environment and willingness to engage and understand technical solutions challenges and issues.
Expert understanding of the Lab business processes drug development experience an advantage
Ability to break down problems build requirements for development tasks in an agile manner.
Desired Characteristics:
Experience with Cloud technologies Java JavaScript JBoss SQL Windows Server Citrix Integrations
Experience working in remote / global teams.
Entrepreneurial mindset - champions new technology predicts trends and identifies new opportunities based on trends. Ability to make technology choices based on experience and willingness to take calculated risks and experiment with newer technologies.
Ability to develop partnership with stakeholders and develop an inclusive & collaborative environment.
Ability to effectively present portfolio project plans technical roadmaps risks and recommendations to senior business leaders
Certifications such as CSBA CBAP or PMP
Leadership:
Pre-emptively sees downstream consequences and effectively tailors influencing strategy to support a positive outcome.
Able to verbalize what is behind decisions and downstream implications. Continuously reflecting on success and failures to improve performance and decision-making.
Understands when change is needed. Participates in technical strategy planning.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
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Additional Information
Relocation Assistance Provided: No
Required Experience:
IC
Employment Type
Full-Time
