Director, External Quality - Remote
Merck
3 days ago
Remote
United States
Operations
Responsibilities:
- Lead a team of quality professionals accountable for activities at the External Entity (EE) site for manufacturing Company products and devices.
- Provide quality oversight over molding, manufacturing, assembly, testing, packaging, storage, and distribution.
- Ensure products are produced/tested using approved processes in conformance with applicable regulatory requirements, regulatory filings, and company policies.
- Serve as a subject matter expert for EQA and manufacturing quality systems, technology platforms, regulatory expectations, and/or external entity management.
- Represent the company in external forums and lead complex cross-functional initiatives to develop/optimize quality and business processes.
- Manage and lead Quality Assurance professionals, including regular 1-on-1s and Employee Development Plan discussions.
- Collaborate cross-functionally to improve effectiveness and efficiency of quality management and systems supporting the external network.
- Oversee performance management (objectives, revisions, year-end evaluation, and performance discussions).
Qualifications:
- Minimum four-year degree in Science, Engineering, or related technical discipline.
- Minimum 12 years relevant experience in Pharmaceutical and/or Medical Device industry with strong knowledge of Quality Systems/QA/QC and global GMP and MDCP regulatory requirements.
- Good knowledge and experience with MDCPs; familiarity with domestic and foreign regulations and compendia governing plant operations.
- Previous experience participating in regulatory inspections.
Required skills:
- People leadership, quality assurance, QMS, regulatory compliance, audit management, driving continuous improvement, supplier quality management, process improvements, FDA inspections, training and development, decision making, strategic thinking.
Application instructions:
- Apply today. (Current employees/contingent workers: use “apply HERE”.)
- Lead a team of quality professionals accountable for activities at the External Entity (EE) site for manufacturing Company products and devices.
- Provide quality oversight over molding, manufacturing, assembly, testing, packaging, storage, and distribution.
- Ensure products are produced/tested using approved processes in conformance with applicable regulatory requirements, regulatory filings, and company policies.
- Serve as a subject matter expert for EQA and manufacturing quality systems, technology platforms, regulatory expectations, and/or external entity management.
- Represent the company in external forums and lead complex cross-functional initiatives to develop/optimize quality and business processes.
- Manage and lead Quality Assurance professionals, including regular 1-on-1s and Employee Development Plan discussions.
- Collaborate cross-functionally to improve effectiveness and efficiency of quality management and systems supporting the external network.
- Oversee performance management (objectives, revisions, year-end evaluation, and performance discussions).
Qualifications:
- Minimum four-year degree in Science, Engineering, or related technical discipline.
- Minimum 12 years relevant experience in Pharmaceutical and/or Medical Device industry with strong knowledge of Quality Systems/QA/QC and global GMP and MDCP regulatory requirements.
- Good knowledge and experience with MDCPs; familiarity with domestic and foreign regulations and compendia governing plant operations.
- Previous experience participating in regulatory inspections.
Required skills:
- People leadership, quality assurance, QMS, regulatory compliance, audit management, driving continuous improvement, supplier quality management, process improvements, FDA inspections, training and development, decision making, strategic thinking.
Application instructions:
- Apply today. (Current employees/contingent workers: use “apply HERE”.)