Director, External Quality - Remote

Job Overview

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

• Lead a team of quality professionals accountable for activities at the External Entity (EE) site associated with the manufacturing of company products and devices.
• Provide quality oversight over molding, manufacturing, assembly, testing, packaging, storage, and distribution of products manufactured at an EE.
• Ensure products are produced or tested following approved processes/methods in conformance to all applicable regulatory requirements, regulatory filings, and company policies.
• Act as a subject‑matter expert for both EQA and the manufacturing division in specific Quality Systems, technology platforms, regulatory expectations, and/or external entity management.
• Represent the company in outside forums on areas of expertise, driving complex cross‑functional initiatives to develop/optimize quality/business processes.
• Manage and lead a small team of Quality Assurance professionals, holding regular 1‑on‑1 meetings and employee development discussions.
• Collaborate with other functions to continuously improve the company’s effectiveness and efficiency in quality management and quality systems supporting the external network.
• Oversee performance management processes including objectives setting, approval, revision, year‑end evaluation, and performance discussions with direct reports.

• Minimum four‑year degree in science, engineering, or related technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent).
• Minimum 12 years relevant experience in the pharmaceutical and/or medical device industry with thorough knowledge of quality systems, quality assurance, and quality control including GMP and MDCP regulatory requirements.
• Good knowledge and experience with MDCPs.
• Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• 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.

• Adaptability
• Audit management
• Decision making
• Driving continuous improvement
• FDA inspections
• Motivation management
• People leadership
• Process improvements
• Quality Assurance (QA)
• Quality Management Systems (QMS)
• Regulatory compliance
• Sterile manufacturing
• Strategic thinking
• Supplier quality management
• Training and development

While specific preferences are not listed, the company values experience in opportunity identification and solution implementation within the organization.

US and Puerto Rico Residents Only. The company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accommodations can be requested if needed.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights and EEOC GINA Supplement resources. We encourage respectful challenge of ideas and inclusive collaboration among diverse perspectives.