Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
5 Years
Description
- 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
Qualifications
Highest qualification: University
- 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 quality field (ISO, GMP etc) 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)