We are seeking an experienced laboratory professional to lead strategic remediation and compliance initiatives in a regulated medical device environment. This role is critical to ensuring laboratory infrastructure, equipment, documentation, and practices meet global regulatory standards.
Overview
Key Responsibilities and Qualifications below outline the expectations for this senior role.
Responsibilities
* Lead and execute laboratory remediation programs aligned with cGxP standards (ISO 13485, GLP, FDA QSR, GDP).
* Develop risk-based strategies for equipment qualification, calibration, and lifecycle management.
* Own CAPA and deviation processes, ensuring timely resolution and robust documentation.
* Author and approve SOPs, work instructions, and technical documentation in line with GDP and Data Integrity standards.
* Deliver training programs and mentor staff on compliant lab practices, equipment use, and safety.
* Collaborate with Engineering, QA, Facilities, and external service providers to support lab operations.
* Implement lean processes for inventory and procurement, and lead 6S and EHS initiatives.
Qualifications
* Bachelor’s or Master’s degree in Engineering, Science, or related technical discipline.
* Minimum 10 years of experience in a regulated medical device or pharmaceutical laboratory.
* Strong knowledge of cGMP, GLP, GDP, ISO 13485, and EHS standards.
* Proven track record in leading remediation and compliance initiatives.
* Proficiency with Blue Mountain software.
* Excellent communication, organizational, and stakeholder management skills.
* Experience supporting audits and regulatory inspections.
* Six Sigma or Lean certification preferred.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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