Sr. Manager/Manager Quality Assurance

Position Overview:

The Sr. Manager/Manager of Quality Assurance (QA) Manager will lead the maintenance and continuous improvements of the organization's Quality Systems to ensure compliance with GMP requirements. The QA Manager act as the primary contact for GMP Systems supporting contract GMP QC testing and oversees the approval process for releasing data and products. Interested in hearing more about this opportunity with a small growing organization? Apply in!

Key Responsibilities:

• Oversee and manage the organization's quality systems (i.e. change control, document control, deviation/investigation/CAPA, and the internal audit program). This would also include managing inspections and audits.
• Act as the on-site representative for regulatory inspections and customer audits, lead inspection readiness activities and audits, coordinate responses to audit findings, and monitor the completion of corrective and preventive actions.
• Review updates to global regulatory requirements and industry best practices, facilitating their implementation through new or revised processes.
• Develop and secure Quality Agreements with vendors and clients.
• Manage supplier qualifications and ensure procurement specifications are met.
• Review and approve company procedures, reports, test methods, validation plans, and other documents to ensure regulatory compliance.
• Foster a GMP and Quality mindset throughout the company.
• Communicate issues and questions between staff and management.
• Collaborate with the Medical Director to ensure proper oversight of clinical testing and compliance with the Clinical Laboratory Improvement Amendments (CLIA).

Key Qualifications:

• Bachelor's or Master's degree in a science-related field.
• At least 8 years of experience in Quality Compliance or Quality Systems within GMP operations in the pharmaceutical or biopharmaceutical industry.
• Prior experience supervising Quality staff.
• Strong experience in quality audits, and experience with maintaining and leading continuous improvement initiatives with quality systems.

• Strong understanding of CLIA regulations for clinical testing and knowledge of quality risk management.
• Experience in inspection readiness.
• Experience with MasterControl is preferred.
• Experience with large molecules is preferred.
• ASQ CQA is a plus.