Description
The Compliance Manager, Quality Assurance will be responsible for the development, maintenance, monitoring, and continuous improvement of the Quality Management System (QMS) at ATLAB-Indianapolis, a next-generation commercial-scale facility for sterile radiopharmaceutical manufacturing. This position plays a critical cross-functional role in ensuring site readiness and ongoing compliance with FDA, EMA, ICH, and applicable GMP requirements through effective management of quality systems, inspection readiness programs, audits, metrics, training governance, and continuous improvement activities. This role will provide site oversight contributing directly to the timely and compliant delivery of life-saving therapies.
Key Responsibilities - Provides daily oversight and ownership of the site Quality Management System (including the electronic document system).
- Develops, compiles and monitors appropriate KPI's for site quality metrics, including quality trends, Right First Time (RFT), record closure turnarounds, and support of timely batch release. Presents KPIs at quarterly management reviews.
- Develop and manage document control processes and change management.
- Directs investigations of product complaints, raw material quality issues, and system-related discrepancies. General responsibility for all supplier quality oversight.
- Develops and executes internal audit program for multiple OranoMed sites (cross-site responsibility).
- Develops and executes site CAPA program and change management program, along with all required effectiveness checks.
- Ensures completeness, accuracy and compliance with all documentation. Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metric/ KPIs.
- Participates in Regulatory/FDA inspections and audits by providing information or expediting/ obtaining information required by the inspectors/auditors.
- Develops and manages the site data integrity program.
Requirements
Qualifications Education - Bachelor's degree in Chemistry, Engineering, or a related technical field.
Experience - Minimum of 5 years of progressive challenging experience in quality assurance.
- 3+ years as a supervisor or above, in pharmaceutical or related regulated industry
- Sterile injectable and radiopharmaceutical experience is a plus
- Strong attention to detail and organizational skills.
- Proficiency in document management systems and Microsoft Office Suite.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a team environment.
