Exciting opportunity for an experienced quality management professional with a track record in the pharmaceuticals industry to join an established pharmaceutical company here in Singapore as the lead of the site quality organization with overall responsibility and oversight of all quality related activities onsite, including making product quality and batch disposition decisions, and continuous improvement of quality systems through local and global initiatives

Responsibilities:

• Develop and maintain Quality Organization; QA, QC, Quality Operations and Compliance
• Implementation of company’s quality system and all applicable GMP regulations
• Primary liaison with regulatory agencies and responsible for compliance with regards to any product actions.
• Prepare quality assurance internal and external audit agenda and participate in audits
• Lead on-going continuing efforts and quality planning to improve manufacturing quality systems and processes
• Lead quality system improvements, which result from internal audits, corrective action/preventative action (CAPA), practice quality improvement (PQI) process and quality board issues
• Responsible for release of final product and disposition of non-conforming material
• Responsible for product traceability and finished goods release processes
• Set quality culture by visible leadership

Requirements

• Master’s degree in Engineering, Science or a related technical discipline with more than 5 years in the pharmaceutical industry and more than 7 in manufacturing environment with a track record in people management
• Skilled in coordinating efforts with various construction functions / projects
• Strong communication skills, with the ability to communicate compliance requirements to strategic business unit functions and other personnel
• Credibility and gravitas to gain the respect and trust of stakeholders and team/s
• Proven leadership and people management experience