Manager, NCIS (Quality Assurance)

Career in the Hospital
Join our incredible team at the National University Hospital (NUH), where we believe that a hospital is more than just a workplace. Every day, we witness the remarkable impact that our healthcare professionals can have on individuals, families, and entire communities.

At NUH, we are driven by a shared purpose - to lend a helping hand to those in need, to be a source of support and healing, and to empower patients to live their best lives.
We are looking for passionate and committed individuals to join us as we transform lives and create a lasting impact in the lives of our patients. The impact you make at NUH will be profound, regardless of the role you take up in the hospital.

About NUH
The National University Hospital (NUH) is Singapore's leading university hospital, with a proud heritage dating back to 1905 with the establishment of what's now the NUS Yong Loo Lin School of Medicine. Our strong ties with the medical school have shaped us into a unique institution, allowing us to seamlessly integrate clinical care with teaching and research. As a university hospital, we go beyond the realm of providing tertiary medical care. We are a hub of knowledge and innovation, attracting healthcare professionals who are passionate about pushing boundaries and making significant contributions to the field.

About Department and Purpose of the Position

NCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of expansion of its Specialised Programmes and to become a Reference Centre of Excellence. We are looking for a Quality Assurance (QA) Team Lead for the QA department in the organisation.
The candidate will lead and direct the assigned Quality Process (e.g. Quality Operations, Quality Management Systems, External Vendor Quality Oversight, Quality Supplier Management, Quality Compliance and Disposition) for NCIS Specialised Programmes (specifically Cellular Therapy and Haematopoietic Stem Cell Transplant) and other provided services.

Key Responsibilities

• Responsible to lead and direct the assigned Quality Process
• Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
• Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations
• Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
• Owns policies and procedures of the assigned Quality Process
• Partners with and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
• Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
• Ensures deviations from assigned Quality Process are documented and investigated
• Ensures QA personnel are qualified and trained to perform assigned tasks
• Develops strategies for assigned Quality Process to ensure a state of inspection readiness
• Supports inspection and audit preparations
• Participates in inspections, audits and Quality Management Review
• Escalates quality and compliance risks to Head of Quality
• Supports improvement initiatives, programs and projects of the assigned Quality Process
• Note: Other responsibilities may be assigned by Head of Quality, or senior management

Key Requirements

• Bachelor or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent, with preference of more than 4 years of relevant work experience in Quality Assurance Lead role in the pharmaceutical/biotechnology/medical device/healthcare industry, preferable with increasing people management responsibilities.
• At least 2 years of leadership experience
• Extensive knowledge in Quality Management System concept
• Extensive knowledge in regulations and industrial guidance especially for stem cell / cell and gene therapy
• Excellent communication and able to engage stakeholders effectively from different functional units
• Critical thinking and problem-solving skill are of advantage.

Closing & Applications
When you join NUH, you become part of a dynamic and collaborative environment where expertise, knowledge, and compassion all come together.

Working in healthcare offers satisfaction that extend far beyond the ordinary. The smiles of gratitude from patients and the profound sense of fulfilment that comes from helping others cannot be measured. It is a career that allows for both personal and professional growth. The challenges you encounter in this rapidly evolving industry push you to constantly expand your knowledge and skills, as well as encourage lifelong learning.

Be a part of a team that gets to create a transformative healthcare experience for our patients and professionals alike.