BD (Becton, Dickinson and Company) Sr. Customer Quality Manager, Global Accounts in Franklin Lakes, New Jersey
Job Description SummaryThe Sr. Customer Quality Manager (Sr. CQM), Global Accounts, is responsible for directing all Pharmaceutical Systems Customer Quality activities related to the assigned Global Pharmaceutical Systems account(s). Reporting directly to the Director, Customer Quality, Global & Strategic Accounts, you will serve as the primary Quality contact for all assigned customer quality activities covering multiple global pharmaceutical customer sites.
The Sr. CQM, Global Accounts is responsible for all strategic customer quality interactions for the assigned pharmaceutical customer(s) global sites, including organizing and leading all aspects of the customer relationship on behalf of BD Quality, leading and participating in customer forums (e.g. Quality Forums, Business Review meetings, etc.), negotiating BD’s Quality position with the customer, triaging and leading customer complaints and escalations, negotiating and ensuring compliance to contractual Quality agreements and specifications, leading quality improvement projects on behalf of the customer, collecting and analyzing customer surveys and proactively anticipating their customers Quality needs. In this role, you will:
Bring the global customers’ voice to Pharmaceutical Systems (projects, future development, issues, risks, trends scorecard results, etc.) and are the voice of BD Quality to the global customer
Interact comfortably at the most senior management level and know when to involve BD senior leadership
Effectively manage escalations, complex situations and internal resources to ascertain global solutions for customer issues
Stay abreast of quality and technical knowledge that is critical for understanding customer technical, scientific and quality requirements and BD’s capability to meet them
Influence the BD network to improve the Customer experience regarding Quality topics
Liaise closely with worldwide Quality counterparts and Global Account Managers/Directors and core teams to integrate international quality and compliance initiatives and promote worldwide business improvement for their global customer(s).
You will be a key member of Account core team, and will serve as the Quality team member for the account. Through outstanding communication, effective problem solving and active management of ambiguous situation, you will ensure 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.
Position Specific Overview:
Strong knowledge of Engineering and Pharmaceutical Processing (incoming inspection, filling, etc.) is a plus
Excellent communicator and negotiator, capable of interfacing with Pharmaceutical customers
Demonstrates a commitment to service, values and professionalism through appropriate conduct and demeanor at all times. Adheres to and exhibits the company's core values
Demonstrates the ability to interact and influence autonomously with internal and external senior stakeholders
Demonstrates exceptional customer service and interacts effectively with direct reports, peers, customers, visitors, staff and the broader company and Pharmaceutical Systems community
Maintains confidentiality and protects sensitive data at all times.
Strong interpersonal, organizational, communication and presentation skills; ability to give and receive feedback
Ability to understand 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.
1. 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
Facilitate expert-to-expert discussions between BD and the customer regarding quality topics
Build 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 customer-specific Quality metrics 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
2. 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 possible and/or appropriate
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.)
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
3. 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 (as necessary), 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 milestones
Educate the customer on BD’s sample packaging and shipment processes from various customer sites
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
Measures customer complaint right-first-time (RFT) metrics and implement measures for improvement
Measures CAPA closure timeliness on behalf of the customer
4. Lead Quality improvement projects impacting the assigned customer(s)
Lead site or multi-site BD projects and/or CAPAs that address major customer issues or initiatives
Through superior leadership, identify and lead business cases for change within the BD network to improve the customer experience
5. 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)
6. 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
Engages others in developing successful new ideas to improve products, processes, services that fulfill emerging needs and reinforce BD position
Education and Experience Requirements:
Minimum of a BS/MS degree in science, engineering or other relevant discipline with extensive experience in the pharmaceutical, medical device or other regulated field (mainly GMP, GLP, GCP), including solid experience in quality assurance, quality control, quality systems and/or regulatory compliance
Ability to work globally. May involve 25-40% domestic and international travel (US and EU)
Strong technical writing experience required (English). Conversational French is a plus
Level will depend on years of relevant experience, and size/complexity of customer base
Strong knowledge of applicable regulations and standards, including 21 CFR 820, 210, 211, ISO 13485, etc. required. Ability to work effectively across diverse areas of a company and manage complex structures.
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.
Primary Work LocationUSA NJ - Franklin Lakes
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