Director, External Quality - Remote

Merck•Durham, NC

1d•Remote

About The Position

Leading a team of quality professionals ensuring compliance and quality oversight across external manufacturing of products and devices. In this role you will be a 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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.