Senior Manager, Quality Assurance

About the role

The Senior Manager, Quality Assurance is responsible for the direct oversight, management, and execution of Quality Operations and Quality Systems activities at the Cranbury, NJ, and Rye, NY facilities, ensuring compliance with current Good Manufacturing Practices (cGMP), FDA regulations, applicable international quality standards, and company policies and procedures. Provides leadership, oversight, and direction for Quality Operations and Quality Systems including manufacturing floor operations, incoming material inspection, raw material disposition, in-process quality review, and finished batch release. Ensures the effectiveness and compliance of quality processes supporting facilities, equipment, utilities, materials, production, laboratory, packaging and labeling, distribution, and other GxP regulated operations. Accountable for maintaining compliance with applicable FDA regulations, current Good Manufacturing Practices (cGMP), Quality System Regulations (QSR), applicable ISO standards, and global regulatory requirements. Leads inspection readiness efforts, supports regulatory inspections. Serves as the designated backup to the Site Director of Quality.

Responsibilities

• Provides leadership and oversight for Quality Operations for quality floor operations which include but are not limited to manufacturing floor quality support, line clearance activities, product sampling, incoming material inspection, material disposition, and batch release activities.
• Oversees the review and approval of raw materials, in-process materials, and finished product batches to ensure compliance with cGMP requirements and internal quality standards.
• Reviews and approves product stability data and supports stability program management.
• Directs batch record review and batch data review activities to ensure product quality and regulatory compliance.
• Develops, implements, and maintains Quality Assurance procedures, policies, and processes to support compliant operations and continuous improvement.
• Provides oversight of the site's environmental monitoring program which includes routine monitoring, annual requalification activities, and post-maintenance requalification of manufacturing rooms and other classified plant areas.
• Manages Quality Assurance owned equipment and ensures appropriate calibration, preventative maintenance, and life cycle management activities are completed in accordance with established procedures.
• Leads and contributes to the development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.
• Leads deviation investigations, root cause analyses, corrective and preventive actions (CAPAs), and effectiveness monitoring in the Quality and Manufacturing areas.
• Leads non-conforming material investigations and product quality issues.
• Reviews and approves OOS/Laboratory investigations.
• Lead or support regulatory inspections, customer audits, and internal audits while ensuring