This position is required to lead the Quality Investigation Engineering Excellence team which is Quality representative and partner for the site to ensure GMP compliance at Takeda Singapore.

•Quality Systems Representative

◦Lead a team of Quality Excellence Specialists in ensuring Quality oversight for the site with respect to Deviation Management/Change Control.

◦Partner the departments (e.g. manufacturing, engineering operations, PDTS and QC) and helping with implementation and adherence to the Deviation/Change Control related Quality systems and GMP requirements

◦Participate in any corporate/division alignment meetings for information learning & sharing and alignment of best practices

•Operations

◦Assume the responsibility of document owner for documents from the area of responsibility.

◦Together with the SME, assist and approve the gap analysis for current SOP/practices with the various subject matter expert to ensure compliance with DPs/DMs revision, and where gaps are identified, proposed mitigation plans for Deviation/Change Control Management System

◦Participating in investigations to support site wide deviations/change control and review/approve the investigation report.

◦Ensure timely review and approval of investigations to support timely release of BDS and raw material.

◦Support deviations/change control-related metrics for site and global reporting.

◦Lead and participate in Improvement initiatives Quality Team, and not limited to Deviation/Change Control Management System.

◦Review and approve test scripts, protocols associated with deviations/change control.

◦Ensure documents relating to deviations/change control are properly and timely archived.

◦Reviewing/approving Change Controls for supporting areas

◦Support the compliance, regulatory, audits and training activities as required and any other responsibilities as assigned by supervisor

•Leadership

◦Manage, coach and develop Quality Excellence specialists and contribute to the growth of those professionals.

◦Ensure succession planning by identifying and groom high potential employee to be the successor for the supervisor role to ensure business continuity

◦Build strong partnership with all other departments to ensure open communications and acceptance

◦Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct

•EHS

•Responsibility to adhere to any applicable EHS requirements

•Any other duties as assigned by supervisor.

Education and Experience Requirements

•The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline. Additional certification and trainings such as auditor training or QP training will be advantageous.

•At least 7 years in pharmaceutical industry, with 3 years in a senior position, in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, ideally in a multinational company.

•FDA/EU cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international regulatory network.

•Six Sigma Greenbelt certification would be advantageous

Key Skills and Competencies

•Good knowledge in the various regulatory requirements

•Process and product knowledge is preferred

•Product Release knowledge is preferred

•Able to logically solve problems in order to find timely solutions

•An ability to interact and communicate with all types of personalities in an effective and diplomatic manner

•Good presentation skills to conduct training and support audits and

•Serves as a delegate for QA manager in her absence and approve any QA related documents.