Director, External Quality - Remote

Role Overview

Lead a team of quality professionals ensuring compliance and quality oversight across external manufacturing of products and devices. Subject matter expert in EQA and manufacturing quality systems, technology platforms, regulatory expectations, and external manufacturing management.

What You Will Do

Lead a team of quality professionals, provide quality oversight, ensure products are produced or tested following approved processes/methods, act as a subject matter expert, represent the company in outside forums, manage and lead a small team of Quality Assurance professionals.

Why It Might Be a Fit

Minimum four-year degree in Science, Engineering, or other relevant technical discipline, minimum of 12 years relevant experience in the Pharmaceutical and/or Medical Device industry, strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills.

Requirements

• Minimum four-year degree in Science, Engineering, or other relevant technical discipline
• Minimum of 12 years relevant experience in the Pharmaceutical and/or Medical Device industry
• Good knowledge and experience with MDCPs
• Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills
• Ability to work across boundaries; demonstrated interpersonal, relationship building, and leadership skills
• Proficiency in English, both verbally and in writing
• Previous experience participating in regulatory inspections
• Familiarity with domestic and foreign regulations and compendia governing plant operations

Benefits

• Flexible working
• Hybrid working model
• Equal opportunities to all employees and applicants for employment
• Prohibition of discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics