Quality Assurance Manager

Overview

The Manager - Quality Assurance is responsible for providing guidance, support, and expertise in maintaining regulatory compliance according to established standard operating procedures and applicable regulatory requirements. The Manager - Quality Assurance should develop a sense of responsibility toward their duties.

• Bachelor’s degree or at least 5 years of relevant work experience. At least 5+ years of applicable work experience.
• At least 3+ years of experience in quality, auditing and/or project management.
• Demonstrated experience and working knowledge of applicable regulations as they relate to EPL Archives services.
• Strong communication skills (both written and oral).
• Ability to work independently when necessary and participate in a team environment.
• Ability to balance and coordinate workload for multiple projects.
• Ability to maintain strict confidentiality regarding all matters concerning the company, its customers, and employees.
• Ability to use Microsoft Office (Word, Excel and PowerPoint).
• Superior role model leadership behaviors – ability to lead and motivate others while displaying integrity, intensity, innovation, and involvement.

The Manager - Quality Assurance is responsible for providing guidance, support, and expertise in maintaining regulatory compliance according to established standard operating procedures and applicable regulatory requirements. The Manager - Quality Assurance should develop a sense of responsibility toward their duties to include the following:

• Completion of the orientation program with:
  An understanding of our work and how it must be completed in compliance with applicable US and OECD regulations and our Standard Operating Procedures.
• An understanding of Chemical Safety and the proper use of safety equipment.
• An understanding of EPL Archives’ quality program requirements, including:
  Communication of the company's quality program to internal and external stakeholders;
  Participation in the development of processes and procedures that meet quality standards;
  Participation and/or oversight of regulatory training and development;
  Participation and/or oversight of company audit programs.

Develops and manages the quality strategy for the site(s) in alignment with quality function and overall Company goals. Helps create a quality-focused culture through collaboration, training, metrics, and risk-based assessments. Works with various functions, including operations, client services, facilities, and IT to develop, implement, and continuously improve the Quality Management System. Manage the development of quality assurance staff, including coaching and development recommendations through performance reviews.

Manage the daily operation of the quality assurance unit, including maintenance of an effective system for completion of day-to-day work assignments, indexing of quality assurance records and oversight of the regulatory training program. Manage/assist with the evaluation of overall compliance of the EPL Archives facility with applicable standard operating procedures (SOPs) and regulatory requirements through internal facility and process focused inspections.

Ensure proper distribution of findings to Archives Management personnel and staff for resolution, including initiation of SOP changes based on inspection findings. Develop/coordinate changes to SOP’s, controls, and procedures sufficient to successfully satisfy any audit or other regulatory review performed by FDA, EPA, and other agencies with significant authority to conclude on the business operating compliance with complex regulations. Manage/provide oversight for Corrective Action Investigations.

Lead and coordinate regulatory/client/facility audit response and SOP Updates between EU/US sites, ensuring continuity of procedures between sites. Provide oversight for the maintenance of all inspection activity records; identify, document and report deviations from applicable regulations and standard operating procedures to Archives Management; ensure appropriate corrective actions have been completed. Provide oversight for the collection and…