Job Description Summary
The TGS (Technology Global Services) Medical R&D and RAQA Business Partner is global technology leadership role accountable for defining and driving the technology / digital strategy for a specific business unit within the Medical Segment. The incumbent will report into the TGS Business Unit Senior Director, and will be accountable for shaping and defining R&D, Regulatory and Quality technology strategy in alignment with the business unit objectives and operations, while also ensuring alignment with those of the other business units and global R&D, Regulatory and Quality functions. In turn, the incumbent will be responsible for managing the total portfolio of projects, driving / leading their execution, and managing crucial relationships across both business, function and TGS stakeholders / leadership teams. The R&D/RAQA Business Partner is essential role that will deliver solutions that can directly impact the efficiency, effectiveness and overall compliance across new product development, sustaining engineering, product registration, regulatory submission, product management and quality operations.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
The scope of work will span across the product management operations for R&D, Medical Affairs, Regulatory and Quality, stretching across the end-to-end Idea-to-Retire and Plan-to-Deliver processes. As such, the selected individual must have both functional knowledge of these operations and processes, and understanding of the technology eco-system that supports them.
The R&D/RAQA Business Partner must have strong, proven business relationship leadership skills and the ability to implement / deliver global programs. The selected individual must have strong communication skills and the ability to effectively communicate sophisticated technical challenges into business language. More over, the incumbent will have experience in managing a portfolio of projects, defining and calculating business value from technology solutions, and effectively work in a sophisticated matrix organization with multiple priorities. Tactically, the position will need excellent facilitator skills working amongst the various businesses and functional organizations, as well as a skilled negotiator and diplomat when dealing with all levels of the organization.
Overall, the TGS R&D/RAQA Business Partner within the Medical Segment is an advocate for the business objectives and capability needs, while also being an advocate for TGS's enterprise capabilities and standards. A successful candidate will be highly regarded by both the Business and TGS leadership, skilled at navigating and driving large matrix teams, and successful at delivering technology solutions for PLM, PDM, Complaints Mgmt, Regulatory Management, Medical Affairs clinical trials and claims management.
Degree of Accountability:
Accountable for the total portfolio of commercial projects for the selected Medical Segment business unit. Responsible for partnering and influencing senior leaders (ex. VP of R&D, VP of Regulatory, BU President, VP of TGS, CIO) across the organization. Solely responsible for ensuring all commercial projects for the business unit are successfully delivered, return the targeted business value, and align with enterprise technology roadmaps and standards.
Financial Impact:
Execution led by this role will have impact on worldwide strategic planning for revenue and operational excellence. The individual will be responsible for a commercial project portfolio up to $10M, with targeted business value returns 2-3x the cost of the project.
Quality Impact:
Deep understanding of how to validate systems and ensure their compliance with applicable FDA and ISO regulatory requirements is a must. Additionally, understanding of how the technical design of systems could impact regulatory requirements is essential. In particular, experience with document management, product lifecycle management, regulatory submissions, complaints management and quality system management is a must.
Minimum Qualifications:
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