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 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.

Qualifications and Requirements

• A 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 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