PS_客户质量工程师_广州/深圳

该职位来源于猎聘 Position Summary（职位概述） Reporting directly to Manager, Customer Quality China. Customer Quality position is responsible for directing all BD Pharmaceutical Systems Quality Management activities for assigned Regional account customers in China as it relates to Customer interface.

This position is responsible for all customer quality interfaces for customers in the assigned region, including negotiation and approval of Quality agreements and customer specifications alignment for the region, management of Customer complaints and escalations, facilitation of Customer audits, change notification and daily Customer support. The role closely interacts with China 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/China 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 stakeholder engagement; and people development; the incumbent produce durable and industry leading results supporting key business drivers. KEY RESPONSIBILITIES（主要职责）

• Assure a high level of customer satisfaction within the region for regional customers through active support in quality field.
• Facilitate expert-to-expert discussions between BD and the customer regarding quality topics, especially for upstream proactive customer engagement, take lead in Quality Forum.
• Negotiate BD’s Quality position with the customer, as necessary, on quality topics.
• Monitor and manage quality initiatives and issues with applicable customer base. Engage with customers in all matters related to product quality. Provide high level "consulting" services and translation to the customer base in all matters related to quality.
• Bring customers’ voices to Pharmaceutical system (projects, future development, issues, trends…) and manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
• Proactively manage the triaging, escalation 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 milestones; 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 and assure post-market compliance with CFDA requirement.
• Define and negotiate contractual Quality Agreements, as appropriate; identify customer’s needs and expectations; Influence the use of BD’s standard Quality Agreement template.
• Lead the review and negotiation 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).
• Effectively navigate and lead through the challenges of change and establish global stakeholder engagement focused on win-win solutions.
• Continuously evaluate progress toward objectives, adapting them to meet customer and business needs.
• Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by plant/business/function objectives Support BD preparation activities for customer audits, as appropriate. SKILLS AND ABILITIES（技能）
• Typically requires a minimum of a BS degree in science, engineering or other relevant discipline with a minimum of 3-5 years of experience in the pharmaceutical, biological or other regulated field (mainly ChP, GMP, GLP, GCP) with a minimum of 3 years of experience in quality assurance, quality control, quality systems and/or Packaging Development / regulatory compliance.
• Knowledge in the drug combination product testing (for instance E&L, SubVP, gliding force) is preferred
• Strong communicator capable of interfacing at senior levels with pharmaceutical customers.
• Proven track record of working in cross functional
• Proficiency in English ,,Strong technical writing experience required (English); conversational French preferred.
• May require 40% to 50% travel.
• Preferred - Proven ability to work in multicultural environment (globally) and working collaboratively cross functional form strong relationships on a global level.
• In-depth understanding of the application of quality systems to the pharmaceutical (and medical device industry).
• Good presentation skills.
• Good negotiation skills. DESIRABLE（优先条件） Familiar with the client's manufacture and vendor quality management is prefered