Job Responsibility:

• Develops strategy and executes the direction for CQA’s approach in collaboration with the Regulatory/Pharmacovigilance/Quality Leadership Team /CQA Management Team and relevant stakeholders. Directs the development and implementation of this approach to ensure an effective CQA oversight and audit program which complies with regulatory requirements and stakeholder expectations. 
• Manages and directs CQA staff and/or provides leadership, development, mentoring and support for direct reports and/or appropriate CQA resources. May be responsible and accountable for the CQA staff recruitment, development, and performance management.
• Continuously evaluates strategic approach, drives changes in the audit program to meet changing needs of the organization, regulatory environment, and industry best practices. Manages development and maintenance of the schedules for internal and external audits (e.g. investigator sites and vendors)
• Assures the creation and implementation of the appropriate strategic risk-based support model for each program. May represent CQA on Study Teams, Clinical Teams and/or Project Teams. 
• Ensures the development of short and long-term risk-based quality strategies in support of development programs based on current regulatory interpretations, and drives their implementation locally and globally as appropriate
• Collaborates within CQA and Development and Nonclinical functions to establish the audit and oversight program
• Provides strategic direction to ensure that the appropriate processes and procedures are in place for CQA
• Responsible for forecasting and managing the assigned budget for the CQA group as part of the overall QA budget
• Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal CQA key stakeholders and development functions, as well as of relevant external stakeholders

Requied Qualifications:

• Bachelor’s degree with a minimum of 6 years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development or Operations
• Minimum of 2 years of significant experience in clinical quality assurance
• Minimum of 2 years people/project management experience
• Experience leading/hosting US and international health authority inspections/interactions.
• Expert knowledge of the pharmaceutical and/or CRO industry, pharmaceutical R&D processes and global regulatory agencies, regulations, and procedures
• Proven experience with GCP Quality Management Systems and quality support and oversight of global clinical trials and drug development operations
• Preferred, experience with monoclonal antibodies, recombinant proteins, and cold chain inventory.
• Practical experience and understanding in GLP and/or GVP.
• Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities.