Director, External Quality - Remote

Job Description

Leading a team of quality professionals ensuring compliance and quality oversight across external manufacturing of products and devices.

In this role you will be subject matter expert in EQA and manufacturing quality systems, technology platforms, regulatory expectations, and external manufacturing management, with the opportunity to represent the company in external forums. Leads complex cross-functional initiatives to optimize quality and business processes driving continuous improvement.

Bring energy, knowledge, innovation to carry out the following:

• 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 our manufacturing division in specific Quality Systems, technology platforms, regulatory expectations, and/or external entity management.
• Represent our 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 Plan discussions.
• Collaborate with other functions to continuously improve our 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 accomplishment evaluation, and performance discussions with direct reports.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Minimum four-year degree in Science, Engineering, or other relevant technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent).
• Minimum of 12 years relevant experience in the Pharmaceutical and/or Medical Device industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including solid knowledge of global 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.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs.

Required Skills:

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