Senior Operations Leader — Regulated Life Sciences
PGD Personal Genome Diagnostics Inc.
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Benefits offered by this job
Job summary
Labcorp is seeking a Director of Operations for the Baltimore site, leading a highly regulated IVD development and manufacturing environment. This senior leader will oversee manufacturing, supply chain, engineering, facilities, quality, and EHS to ensure safe, compliant, high-quality products while driving efficiency and cost leadership.
The role partners with Quality, Regulatory, R&D, and Commercial functions to support lifecycle activities from NPI through commercialization, with
Qualifications
- 10+ years leadership experience in regulated manufacturing/ops.
- 5+ years leading managers and multi-functional teams.
- 5+ years supporting regulatory inspections and audits.
- 5+ years with NPI, technology transfer, process validation.
Responsibilities
- Lead multi-functional operations including manufacturing, supply chain, engineering, facilities, and EHS.
- Establish high-performance culture focused on accountability and continuous improvement.
- Ensure compliance with FDA, ISO 13485, cGMP and global requirements.
- Drive KPIs for safety, quality, delivery, inventory, productivity, and cost.
- Oversee technology transfer and new product introduction with product development teams.
Skills
Education
Job description
Labcorp is seeking a Director of Operations for the Baltimore site, leading a highly regulated IVD development and manufacturing environment. This senior leader will oversee manufacturing, supply chain, engineering, facilities, quality, and EHS to ensure safe, compliant, high-quality products while driving efficiency and cost leadership.
The role partners with Quality, Regulatory, R&D, and Commercial functions to support lifecycle activities from NPI through commercialization, with
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