BD (Becton, Dickinson and Company) Sr. Customer Quality Manager, Strategic Accounts in Franklin Lakes, New Jersey

Job Description SummaryThe Sr. Customer Quality Manager (Sr. CQM), Strategic Accounts (SAM), is responsible for directing all Pharmaceutical Systems Customer Quality activities related to the assigned Strategic Pharmaceutical Systems account(s). Reporting directly to the Director, Customer Quality, Global & Strategic Accounts, the incumbent serves as the primary Quality contact for all assigned customer quality activities covering multiple global pharmaceutical customer sites.

The Sr. Customer Quality Manager, Strategic 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 priority 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.

The Sr. Customer Quality Manager, Strategic Accounts brings the global customers’ voice to Pharmaceutical Systems (projects, future development, issues, risks, trends scorecard results, etc.) and is the voice of BD Quality to the assigned strategic customers. The Sr. Customer Quality Manager, Strategic Accounts must interact comfortably at the most senior management level (Director and VP levels) and know when to involve BD senior leadership. The position must effectively manage escalations, complex situations and internal resources to ascertain global solutions for customer issues. The position must 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. The position must be able to manage multiple competing quality topics and issues simultaneously and proactively provide direction for resolution to BD and to the customer.

This position will liaise closely with worldwide Quality counterparts and Strategic Account Managers/Directors and core teams to integrate international quality and compliance initiatives and promote worldwide business improvement for their global customer(s). The incumbent will be a key member of the 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, the role ensures 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.

Job Description

Responsibilities:

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 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

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 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

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 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

  • Participate in batch disposition strategy with site investigators regarding critical complaints based on knowledge of customer expectations, and internal processes and procedures; follow-up with customers on BD’s batch disposition

  • 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

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, initiatives and/or Complaints, when appropriate or necessary

  • 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

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 at all times. Adheres to and exhibits BD’s core values.

  • Demonstrates the ability to interact and influence autonomously with Director and VP level at customer sites, WW functional leaders, WW PS LT and global customers.

  • 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 protects sensitive data at all times.

  • 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.

Education and Experience Requirements:

  • Minimum of a BS/MS degree in science, engineering or other relevant discipline

  • Minimum of 6-8 years of experience in the pharmaceutical, medical device or other regulated field (mainly GMP, GLP, GCP), including at least 3 years of experience in quality assurance, quality control, quality systems and/or regulatory compliance.

  • Proven 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 BD and manage complex structures.

#LI-OPS

Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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

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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