Associate Director Data and Systems QA

About the role

The Quality Assurance Associate Director of Data and Systems QA plays a critical role in developing and maintaining the quality and regulatory compliance of our computer systems at LP1, along with the Data Management oversight and governance at the site. This person is also the Site Data Leader.

Responsibilities

• Provide direct quality oversight to LP1 computer system validation (CSQA) and assist others in interpretation of regulatory and corporate requirements as it relates to CSQA and data integrity/management.
• Provide quality guidance, technical support and recommendations to efficient CSV and data integrity principles, process issues and continuous improvement initiatives.
• Work as the LP1 Site Data Leader.
• Work with cross functional teams to implement QA objectives.
• Prepare for and participate in internal and external regulatory inspections.
• Coach and mentor Data and Systems QA representatives in aspects of QA support including CSV/Data Management understanding, problem solving, project management and deviation investigation/resolution.

Basic Requirements

• BS or higher degree in Engineering/Science, Computer Science, Information Technology or related field.
• 5+ years in pharmaceutical manufacturing, with specific experiences to computer system validation, and data integrity principles.
• 2+ years of direct people leadership.

Additional Skills/Preferences

• Previous facility or area start up experience
• Previous experience in QA, QC Science/Engineering or Computer Science and Technology
• Prior work with cGMPs, external regulations and inspections
• Strong knowledge of Computer System Validation, Data Integrity/Management, Quality Management Systems, and applicable regulatory requirements
• Demonstrated problem solving and decision-making skills
• Strong technical aptitude and ability to train and mentor others