Manager, QA Compliance

About the role

The Manager for QA Compliance provides management of activities for Site Quality Operations in accordance with RayzeBio policies, standards, procedures and global cGMPs. In addition, the role will be responsible for the Change Controls Review Board, Complaints, Data Integrity, Quality Council, and other Quality metrics.

Job Responsibilities

• Implements and Manages the Change Control Quality System for all GMP activities and works with responsible cross functional areas ensure timely completion.
• Run the Change Control Review Boards, generate meeting minutes, follow up on action items and facilitate resolution when required.
• Communicates effectively with cross functional stakeholders on matters related to change control process.
• Implements and manages the necessary investigations and CAPA review boards at a timely manner.
• Responsible for the site Quality Council program and acts as Quality Council Lead.
• Develops and Maintains Quality Metrics to monitor compliance.
• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues.
• Led site Data Integrity Program.
• Responsible for complaints.
• Participates as a core team member in any corporate or health authority inspections.
• Identifies and reports discrepancies from required work practices or procedures to management.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Leads teams and cross-functional project teams and drives team performance and results.
• Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams.
• Other QA specific responsibilities as assigned by QA management.
• Applies AI to improve team execution and decision-making.

Education And Experience

• At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.
• Minimum 5 years of work experience in Quality Assurance.