Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

Position Summary:
Leading the Singapore - Marsiling and Gul Circle Site Quality teams, the Director of Quality will develop quality system and quality assurance plans to back the Genetic Science Division (GSD) and Life Sciences Group (LSG) businesses.
Reports to Sr. Director of GSD Quality , ensuring that the Singapore Site quality systems align with all applicable internal and external quality regulations and requirements. Lead quality systems, plan strategically, monitor regulations, integrate/improve QMS, enhance product quality according to business and regulatory requirements.
Key Responsibilities:

• Develop and guide a Quality vision and strategic objectives aligned with the quality targets.
• Lead and inspire the strong site quality organization by hiring and developing quality leaders, leading performance expectations, and providing development and training opportunities.
• Use continuous improvement skills to boost product quality, cut costs, and align with objectives.
• Establish site-wide QA priorities and key objectives to improve compliance with regulations and the Quality Management System (QMS).
• Develop, implement, and ensure strict adherence to a quality system aligned with 21 CFR 820, ISO9001, ISO 13485, MDSAP, CE-IVDD, and CE-IVDR across all site locations.
• Collaborate with corporate, group, and divisional quality partners on quality issues, audits, and special projects.
• Further connections within LSG and regions, collaborating with essential collaborators to identify current deficiencies and future needs in Quality Management Systems for business expansion.
• Develop the continual improvement of Quality Management Systems, being responsible for efficient management reviews, handling complaints, implementing CAPA system, regulating changes, conducting internal audits, and supporting the NPI process.
• Support the commercialization of New Product Introductions by working with cross-functional NPI team members.
• Collaborate with the Regulatory organization to ensure compliance with applicable regulations.
• Serve as the Management Representative for Singapore to the US FDA and Notified Bodies
• Perform other miscellaneous duties as assigned.

Minimum Requirements/Qualifications:

• Bachelor's degree in science or engineering fields or equivalent experience.
• A minimum of 15 years of professional quality experience within the Life Sciences, Medical Device, Pharmaceutical, or IVD industry.
• Customer focus: Prioritize customer needs in decision-making, work prioritization, resource investment, and process improvement.
• Quality systems: Ability to implement strong quality systems (ISO 9001, ISO 13485, and MDSAP) that provide vital controls as defined by regulatory, marketplace, and customer requirements.
• Regulatory experience: Preferred experience in IVD/IVDR, 510K, and GXP requirements.
• Impactful Team Building: Ability to build a strong team, aligning strategy, interpersonal structure, and dedicated leaders.
• Operational execution: Clear understanding of mechanisms vital to lead a quality assurance organization efficiently and reliably.
• Flexibility and multitasking: Ability to lead multiple sophisticated projects simultaneously.

Skills Required