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:

• Bachelor’s degree in Engineering, Life Sciences, Information technology or equivalent experience required

• 15+ years in Medical Device or Pharmaceutical industry, delivering technology solutions and services

• Expertise in FDA and ISO regulations, and the delivery of solutions to enable compliance required

• Expertise in Product Lifecycle Management and Document Management

• Knowledge and experience implementing Siemens TeamCenter and Polarion, Salesforce.com, SAP, Trackwise and Veeva (or equivalent systems), and how they integrate to enable end-to-end operations is required

• Functional knowledge of integrated business planning and sales demand forecasting, along with corresponding knowledge of AI, analytics and automation solutions, is strongly preferred

• Excellent communication skills both written and verbal;· Demonstrated ability to effectively interact with diverse collaborators at various levels within organization

• Self-motivated and able to work independently under pressure deadlines

• Experience working in cross functional teams;

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit  https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA CA - San Diego Bldg A&B

Work Shift

NA (United States of America)

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://jobs.bd.com/benefits) .

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$153,900.00 - $254,000.00 USD Annual

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.