Job Description Summary

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.

Reporting directly to the Director, Customer Quality, the Customer Quality Manager position is tasked with directing all BD Pharmaceutical Systems Quality Management activities for assigned key account customers in the US as it relates to Customer interface.

This position will have responsibility for all customer quality interfaces for accounts in the assigned region, including negotiation and approval of Quality agreements and customer specifications for the region, management of Customer complaints and critical issues, facilitation of Customer audits, and daily Customer support.

The role closely interacts with the US Business Directors/Account Managers, works closely with regional leaders and WW Quality counterparts to integrate international quality and compliance initiatives.

Through outstanding communication, effective problem solving, and active management of ambiguous situations, the role ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of the frequency and scale of product quality and organizational issues as well as business process effectiveness. Through internal and external partner engagement; and people development; the incumbent produces durable and industry leading results supporting key business drivers.

Primary Responsibilities:

• Assure a high level of customer satisfaction within the region for Regional customers.

• Facilitate expert-to-expert discussions between BD and the customer regarding quality topics.

• Negotiate BD’s Quality position with the customer, as necessary, on quality topics.

• Supervise and lead quality initiatives and issues with applicable customer base. Engage with customers in all matters related to product quality. Provide high level "consulting" services to the customer base in all matters related to quality.

• Bring customers’ voices to Pharmaceutical system (projects, future development, issues, trends…) and handle customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.

• Proactively lead the triaging, critical issues and closure of priority, high risk and escalated customer Complaints: define the issue and scope of the escalation, qualify the impact to the customer; notify management, develop and communicate through the contact matrix; provide regular updates (face-to-face, by phone, etc.) to BD and to the customer on action plans and achievements; participate in batch disposition strategy with site investigators based on knowledge of customer expectations, and internal processes and procedures; follow-up with customers on batch disposition, including submission/opening of RMA (Return Material Authorization), when applicable

• Stay abreast of changing national/regional regulations and/or standards; advise BD and the customer on how best to navigate changes that impact the customer.

• Define and negotiate contractual Quality Agreements, as appropriate; identify customer’s needs and expectations; Influence the use of BD’s Quality Agreement.

• Lead the review and negotiation of specifications with customer(s); ensure alignment on description of non-conformities/conditions, alignment on control methods and alignment on AQL. Ensure that committed Specifications are aligned with BD’s capability and strategy, through established processes (e.g. specification committee).

• Accountable to WW and regional Marketing teams and regional leaders for Regional customer quality issues.

• Effectively navigate and lead through the challenges of change and establish global partner engagement passionate about win-win solutions.

• Continuously evaluate progress toward objectives, adapting them to meet customer and business needs.

• Pursue and actively lead key partner relationships that support the broader strategy that are impacted by plant/business/function objectives

• Support BD preparation activities for customer audits, as appropriate.

Position Specific Overview:

• Remote candidates will be considered.

• Demonstrates a dedication to service, organization values and integrity through appropriate conduct and demeanor at all times. Adheres to and exhibits our core values

• Maintains confidentiality and protects sensitive data at all times.

• Adheres to organizational and department specific safety standards and guidelines.

• Works collaboratively and supports efforts of team members.

• Demonstrates outstanding customer service and interacts effectively with direct reports, peers, customers, visitors, staff and the broader PS and BDX community.

• Is responsible for the Customer Relationship Management process and may be audited accordingly. Performs regular process reviews accordingly.

Education & Experience Requirements:

• Typically requires a minimum of a BS degree in science, engineering or other relevant subject area with a minimum of 5-8 years of experience in the pharmaceutical, medical device or other regulated field (mainly GMP, GLP, GCP) with a minimum of 3 years of experience in quality assurance, quality control, quality systems and/or regulatory compliance.

• Strong communicator capable of interfacing at senior levels with pharmaceutical customers.

• Strong technical writing experience required (English).

• May require 25 -40% travel.

• Level will depend on years of relevant experience, and size/complexity of customer base.

• Consistent track record to work globally and form strong relationships on a global level.

• In-depth understanding of the application of quality systems to the pharmaceutical (and medical device industry).

• Leadership courage and vision.

• Outstanding presentation skills.

• Exceptional negotiation skills.

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.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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.

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