Director, Product Owner - Change Control- Hybrid

Job Description

Join our team at the forefront of digital transformation in the biopharmaceutical industry. As a Product Owner - Change Control, you will play a pivotal role in simplifying our Quality Management System (QMS) technology stack and enhancing user experience. This is an exciting opportunity to leverage your expertise in digital technologies and quality management to make a significant impact on our business operations and ultimately, patient lives.

Key Responsibilities

• Develop value maps, product roadmaps, and lead roadmap discussions with various stakeholders, communicating the results to the technical teams.

• Understand, prioritize, and develop strategically aligned IT solutions which deliver maximum business value.

• Ensure that Change Control Digital Solutions are true enablers to standard processes and ensure that all enhancements are consistent with this global design.

• Define requirements, translate them between the development and business-facing teams, and document them for GxP systems.

• Drive continuous product discovery to understand user needs and translate that to solutions and product backlog.

• Create, maintain, and continuously prioritize the product backlog to maximize value delivery and long-term sustainability.

• Work with Product Managers to develop and convey accurate and realistic project plans, resource estimates, and timelines in alignment with prioritized business requirements.

• Ensure all IT systems are designed, built, and operated in an SDLC compliant manner and promote the effective use of IT standards and tools.

• Lead the end-to-end development of systems and technology blueprints and product roadmaps.

• Establish strong working relationships with business and technology leaders to align investment planning, portfolio planning, and execution with these roadmaps and architectures.

• Monitor and optimize the product's total cost of ownership (TCO).

• Develop and regularly calibrate metrics of the Digital Products.

• Drive release and support planning and execution (go to market).

• Connect delivery squads with the customers and facilitate direct communication.

Education:

• Bachelor’s degree in computer science, engineering, biology, chemistry, or scientific field.

Required Experience and Skills:

• 10 years of Pharmaceutical Industry experience. Quality/Regulatory and Digital Enablement experience strongly preferred.

• Experience designing, simplifying, and digitizing pharmaceutical industry quality management systems processes.

• Demonstrated ability to lead cross-functional teams, manage complex projects, and drive organizational change.

• Proven experience as a Technical Product Owner, able to define and prioritize product backlogs and collaborate effectively with development teams.

• Excellent verbal and written communication skills, with the ability to present complex concepts to senior leadership.

• Proficiency with Veeva Vault, Trackwise, SAP, Dataiku, and other relevant software for quality management and change control.

Preferred …