QC Lab Compliance Manager

Position Overview
The Quality Control Lab Compliance Manager will focus on ensuring that laboratory operations meet regulatory standards and high-quality outputs, and be responsible for Stability and Sample receipt programs.

• Quality Control Oversight: Oversee laboratory processes and workflows to ensure they meet quality and compliance standards. Develop and manage Stability and Sample receipt programs.
• Equipment Management: Review equipment logbooks, audit trails, preventative maintenance and calibration of equipment.
• Handle Non-Conformities: Investigate and resolve any compliance issues which arise in the laboratories including OOS and deviations. Initiate change controls and implement CAPA as needed.
• Conduct Audits and Inspections: Perform regular audits and inspections of laboratory practices and documentation to ensure compliance with regulatory standards.
• Technology Transfer and Method Validation: Lead protocol/report writing and training. Support the execution in coordination with Lab Managers.
• Training: Review and maintain training records for the department. Identify training needs and design programs to enhance staff competency. Responsible for creating and maintaining department training curriculum in QMS.
• Team Leadership: Lead and train a team of lab compliance officers and technicians.
• Compliance: Stay updated on industry regulations and ensure that the laboratory complies with all relevant laws and standards.
• Data Analysis and Reporting: Review and analyse data related to lab operations and compliance to identify trends and areas for improvement. Prepare detailed reports on lab compliance activities including data integrity and present findings in department and global meetings.

• Education: Bachelor’s Degree in a relevant field such as Chemistry, Biochemistry, Biotechnology or a related field.
• Experience: Generally, 5-7 years of lab experience in analytical method development, validation, and transfer in the biopharmaceutical industry. 1-3 years of investigation and audit experience in compliance with regulatory standards.
• Skills: Proficient or knowledgeable in HPLC, UPLC, Gas Chromatography, Atomic Absorption, Mass Spectrophotometry, pH, CCIT, Water Testing (TOC), Karl Fischer, CIEF, CE-SDS, ELISA and other analytical methods. Skilled in LIMS /Veeva/TrackWise/Master Control