We are the people who give possibilities purpose
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.
In coordination with the Sales/Commercial organization, organize and lead all aspects of the customer relationship on behalf of BD Quality:
Act as the primary point of contact for all quality topics within BD
Facilitate expert-to-expert discussions between BD and the customer regarding quality topics
Possess strong knowledge and expertise of the assigned customer’s products, processes, business models, Quality contacts, manufacturing locations, etc.
Negotiate BD’s Quality position with the customer, as necessary, on quality topics
Consolidate and report Quality metrics specific to the customer in line with Quality Agreements and the Value Offer
Setup, manage and provide regular updates on Quality projects and/or corrective actions applicable to the customer
Share BD’s Quality vision and strategy with the customer, and develop plans to improve the Quality strategy
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 & Specifications:
Identify customer’s needs and expectations pertaining to multiple products and sites internally and at the customer; related to these expectations, educate the customer on BD products specificities, manufacturing processes and quality controls
Influence the use of BD’s standard Quality Agreement template, when applicable and possible
Lead the review and negotiation of Quality Agreements and Specifications with the customer(s); ensure alignment on description of non-conformities/conditions, alignment on control methods and alignment on AQL. Ensure that committed Specifications/Agreements are aligned with BD’s capability and strategy, through established processes (e.g. specification committee).
Sign Quality Agreements and Specifications after cross-functional internal review and validation by applicable associates (Regulatory Affairs, Plant Quality, Medical Affairs, CNC, Supplier Quality, etc.)
Store electronically signed copies of the Quality Agreement in the centralized repository
Ensure regular follow-up of Quality Agreement requirements and Customer Specifications with the customer and BD to continuously maintain alignment with expectations, needs and requirements
Proactively manage the triaging, escalation and closure of priority, high risk and escalated customer Complaints:
Ensure the proper management and escalation of customer Complaints impacting patient safety, product quality and/or compliance to requirements; define the issue and scope of the escalation, qualify the impact to the customer, challenge the customer to obtain necessary information, notify and escalate to BD management, develop and communicate effectively through the contact matrix
Provide regular updates (face-to-face, by phone, etc.) to BD and to the customer on action plans and milestones
Measure customer right-first time (RFT) and implement measures for improvement
Measure CAPA closure timeliness on behalf of the customer, and ensure effective closure of customer CAPAs/corrective actions
Lead Quality improvement projects impacting the assigned customer(s)
Lead site or multi-site BD projects and/or CAPAs that address major customer issues, initiatives and/or Complaints, when appropriate or necessary
Identify and lead business cases for change within the BD network to improve customer experience
Facilitate the preparation, execution and follow-up of Customer Audits:
Serve as the primary entry point of contact for customer Quality audits (for-cause, qualification audits, routine audits) and/or technical visits regarding Quality topics
Work with BD and customer audit coordinators, to organize the audit and support site preparation, including providing audit information, customer status, a copy of previous customer audits and associated observations, customer focus areas and auditor background/expertise (when known).
Ensure existence of the applicable audit/visit CDA (Confidentiality Disclosure Agreement)
Accompany customers to site audits, when appropriate
Assist the site, when applicable, in audit follow-up (CAPA plan exchange with the customer is managed by the site)
Voice of the Customer
Launch, collect and analyze customer surveys – prepare and define action plans for all Quality items
Communicate within the internal organization customer needs and requirements
Engage others in developing successful new ideas to improve products, processes, and services that fulfill emerging needs and reinforce BD position
A POSITION “SPECIFIC” OVERVIEW
-
Strong knowledge of Engineering and Pharmaceutical Processing (incoming inspection, filling, etc.)
-
Excellent communicator and negotiator, capable of interfacing with pharmaceutical customers.
-
Demonstrates a commitment to service, values and professionalism through appropriate conduct and demeanor always. Adheres to and exhibits BD’s core values.
-
Demonstrates the ability to interact and influence autonomously with Director and VP level at customer sites.
-
Demonstrates exceptional customer service and interacts effectively with direct reports, peers, customers, visitors, staff and the broader PS and BDX community.
-
Excellent problem solving and analytical skills.
-
Maintains confidentiality and always protects sensitive data.
-
Strong interpersonal, organizational, communication and presentation skills; ability to give and receive feedback.
-
Ability to understand PS business strategy and key strategic imperatives/metrics and align priorities and resources to deliver on customer commitments.
-
Ability to interface with technical resources and scientifically based teams.
-
Quality Engineering skills including a thorough understanding of industry regulations and basic statistical methods for Quality Assurance (e.g. AQL) strongly preferred.
-
Adheres to organizational and department specific safety standards and guidelines.
SUPERVISION
-
Coach and lead associates pertaining to developing business process enhancement and Pharmaceutical Customers’ expectations
-
Part of Korea PS Leadership team to carry out business / operation plans
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
Required Skills
Optional Skills
.
KOR South Korea - Seoul HQ
