Job Description Summary
Reporting directly to the Manager, Customer Quality Regional Accounts, the Customer Quality / Technical Specialist, position is responsible for directing all BD Pharmaceutical Systems Quality Management activities for assigned Regional account customers in Korea 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 for the region, management of Customer complaints and escalations, facilitation of Customer audits, and daily Customer support. The role closely interacts with the Korea 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 stakeholder engagement; and people development; the incumbent produces durable and industry leading results supporting key business drivers.
¡¤ PRIMARY RESPONSIBILITIES
- Facilitate expert-to-expert discussions between BD and the customer regarding quality topics
- Negotiate BD¡¯s Quality position with the customer
- Monitor and manage quality initiatives and issues
- 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 and manage customer impacting issues
- Manage the training, escalation and closure of priority, high risk and escalated customer complaints
- Participate in batch disposition strategy and internal processes and procedures, RMA (Return Material Authorization), when applicable Stay abreast of changing national/regional regulations
- Lead the review and negotiation Specifications with customer(s);
- Accountable to WW and regional Marketing teams and regional leads
- Effectively navigate and lead through changes and evaluate the progress toward objectives
- Pursue and actively manage key stakeholder relationships
- Promote the use of knowledge management tool
¡¤ EDUCATION AND EXPERIENCE REQUIREMENTS
- Typically requires a minimum of a BS degree in science, engineering or other relevant discipline
- 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
- 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 Organizing and facilitating initiatives with various stakeholders
- Strong technical writing experience required (English); conversational French preferred
- May require 25-40% travel
- Level will depend on years of relevant experience, and size/complexity of customer base
- Proven ability 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)
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