Quality Assurance Manager, APM

JOB PURPOSE

The role is responsible to drive the implementation of Global Quality strategy and site strategic operational goals to ensure products manufactured, released and distributed by the site are fit for purpose for customer and in compliance with regulatory requirements and the Sanofi guidelines.

Lead and develop the Quality Management system, striving for best-in-class business practices to optimising production quality levels and supporting operational excellence.

REPORTING RELATIONSHIP

The job holder reports to the Site Quality Manager (SQM).

SITE LEVEL ACCOUNTABILITIES

Quality Roadmap Development:

Develop annual site quality roadmap that encompasses continuous improvement, current technology deployment, actions plan to ensure sustainable compliance system to meet regulatory requirements and building a compliance quality culture for the site.

Compliance & Integrity:

Take ownership to drive the Compliance & Integrity mindset and related compliance initiatives at site level.

FUNCTIONAL LEVEL ACCOUNTABILITIES

Jurong Quality Units:

• Drive Quality Units to provide efficient, timely and reliable release of products in compliance with cGMP, ICH Q7A, local regulatory regulation and Sanofi Quality guidelines.
• Establish and maintain a good communication link with internal and external stake holders on all quality matters.
• Partner all functions to ensure facilities, equipment and operations are implemented, maintained and consistent with corporate policies, quality objective and GMP regulations to a high level of standards.

Quality Assurance:

• Make informed decision on approving and rejecting of final APIs, intermediates and raw materials to assure those materials and products met the established standards and specifications that fit for the distributed markets supported by CoA.
• Establish a system for batch release after reviewing production and laboratory control records.
• Ensure that effective systems are used for maintaining and calibrating critical equipment.
• Ensure that there is stability data to support retest & expiry dates and storage conditions on API / intermediates where appropriate.
• Investigations and CAPA:
• Drive effective investigations, root cause analysis, and CAPA (corrective and preventive actions) including quality related complaints.
• Manage Quality Alert investigations. Ensure appropriate escalation of quality critical events to top management as per predefined process.

Quality Risk management:

• Implement a Quality Risk management and escalation process for risk mitigation.

Validation:

• Subject Matter Expert on validation, review and approved all validation documents on site such that facilities and buildings, equipment, methods and processes are validated according to international and local regulatory requirements and Sanofi global quality documents.

Others:

• Support site inspection readiness through audit preparation.

• Develop and implement mechanism for assessment of performance measures that motivate the department personnel in continuous improvement in all aspects of the site operations (eg: EHS, Quality, cGMP, IS security, waste minimization). Ensure timely feedback on staff’s performance in enabling inclusiveness behaviour.