Quality Technical Product Manager, Pharmaceutical Diagnostics at GE Healthcare

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical Diagnostics, HealthcareIndustries

Requirements

Bachelor's 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 (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: Experience with Cloud technologies, Java, JavaScript, JBoss, SQL, Windows Server, Citrix, Integrations
Desired: Experience working in remote / global teams
Desired: 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

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 SME’s 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

Skills

Key technologies and capabilities for this role

LIMSChromatography systemsEnvironmental Monitoring systemQuality Management systemFDA complianceEMA complianceICH guidelinesrequirements gatheringbusiness process reviewstakeholder interviewsrequirements analysisprocess mappingtroubleshootingIT systems implementation

Questions & Answers

Common questions about this position

What qualifications are required for this Quality Technical Product Manager role?

A Bachelor's Degree in Computer Science or STEM majors (Science, Technology, Engineering and Math) or equivalent is required, along with strong relevant professional experience in the Pharma or IT Industry, including experience in the Digital Lab domain and technical experience with Quality platforms such as LIMS.

What key skills are needed for this position?

Key skills include strong analytical and creative problem solving, prioritization, requirements gathering and analysis through business process reviews and stakeholder interviews, as well as strong written and verbal communication skills.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What experience makes a strong candidate for this role?

Strong candidates will have professional experience in the Pharma or IT Industry, particularly in the Digital Lab domain, technical experience with Quality platforms like LIMS, and practical experience in Business Analysis methodologies for running meetings, stand-ups, project documentation, and change controls.

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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