Associate Director of Quality Assurance (Quality Systems)

Summary:

The Associate Director of Quality Assurance is responsible for designing, planning, implementing, directing and evaluating a quality assurance function and a quality management system which 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.

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, including but not limited to, the following tasks:
  
• Responsible for compliant execution of the processes related to the development of all quality assurance activities and quality management system.
  
• Administering policies and standard operating procedures (SOPs) relating to the quality assurance function and the quality management system
  
• Establishing and maintaining a document control system for procedures, work instructions and forms
  
• Ownership of final batch record review and disposition.
  
• Ownership of Deviation Management 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
  
• Annual Product Reviews
  
• Facilitate review of CMC sections for regulatory submissions
  
• Preparation and leadership for regulatory inspections
  
• Review and evaluate incident investigations and related Corrective and Preventive Action (“CAPA”) activities and processes. Utilize these to drive quality improvements and respond to process and service issues. Implementing, performing and overseeing internal quality auditing (including applicable vendors or subcontractors), customer quality audit response, and other quality management system activities
  
• Vendor management program
  
• Define, develop and implement short-term and long-term strategies, goals, objectives and tactics relating to the quality assurance function and the quality management system
  
• Review and recommend appropriate corrective action 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, including the following tasks:
  
• Performing periodic internal quality management system reviews and audits
  
• Designing and developing key quality, compliance and performance indicators
  
• Designing, developing, implementing and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality assurance function and the quality management system
  
• Analyzing performance of quality assurance function and quality management system activities and documented resolutions, identifying problem areas, and devising and delivering solutions to enhance quality control and prevent future issues
  
• Represent quality assurance function and quality management system and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assist with quality-related information related to (but not limited to) client assessments, RFPs, contracts and other documentation
  
• Maintain current knowledge base of regulations, corporate policies and standards to ensure that the quality assurance function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices
  
• Identify risks and assumptions in plans, anticipate problems and plan for contingencies. Remove obstacles to move work forward and/or to get efforts back on track.
  

        Skills, Education and Experience:

• Bachelor's Degree is required (Biological sciences, Engineering or related degree); advanced degree is a plus
  
• Minimum of 8 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
  
• Ideally a minimum of 5 years of experience in leading a Quality function, preferably at the senior manager level.  
  
• Proven ability to effectively develop, communicate, and gain support for execution plans with Team members from other functions
  
• Leadership and management skills to grow and manage a high performing Quality organization.
  
• Demonstrated skills in project management and working with vendors and contractors
  
• Strong 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.
  
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, excellent interpersonal skills, organizational skills, written and oral communication skills
  
• 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.