Quality Assurance Manager

3 weeks ago

Boston, Massachusetts, United States KMR Search Group Full time
Job Title: Manager of Quality Assurance

About the Role:
The Manager of Quality Assurance will be responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system that supports clinical development and regulatory approval of products. This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs.

Key Responsibilities:
  • Develop, implement, maintain, and continually assess a quality assurance function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements.
  • Execute processes related to the development of all quality assurance activities and quality management system.
  • Administer policies and standard operating procedures (SOPs) relating to the quality assurance function and the quality management system.
  • Establish and maintain a document control system for procedures, work instructions, and forms.
  • Batch record review and disposition.
  • Manage Deviation and Change Control programs.
  • Assist with executing appropriate quality training for the team.
  • Quality oversight of IT systems used to support Quality activities, including Veeva, document management, Quality training.
  • Gather relevant information and author report related to Annual Product Reviews.
  • Review of CMC sections for regulatory submissions.
  • Assist during regulatory inspections.
  • Conduct incident investigations and identify related Corrective and Preventive Action (CAPA) activities and processes.
  • Performing internal quality auditing (including applicable vendors or subcontractors), customer quality audit response, and other quality management system activities.
  • Execute Vendor management program.
  • Implement short-term and long-term strategies, goals, and objectives related to the quality assurance function and the quality management system.
  • Review corrective actions to ensure consistency with the quality assurance function and the quality management system.
  • Implement a continuous improvement plan for growing and maturing the quality assurance function and the quality management system.

Requirements:
  • Bachelor's Degree is required (Biological sciences, Engineering or related degree); advanced degree is a plus.
  • Minimum of 5 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
  • Ideally a minimum of 3 years of experience in leading a Quality function, preferably at the manager/supervisor level.
  • Proven ability to effectively develop, communicate, and gain support for execution plans with Team members from other functions.
  • Management skills to grow and manage a high-performing Quality organization.
  • Demonstrated skills in project management and working with vendors and contractors.
  • Background in FDA, ISO, EMA, GMP, and ICH requirements ideally for ATMPs.
  • Familiar with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
  • Ability to work in a fast-paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
  • Energetic, flexible, collaborative, and proactive; a leader who can positively and productively impact initiatives.

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