Senior Manager, Quality- Lab Environment

GMP Technologies; Singapore; Sur place; SGD 120 000 - 180 000; Plein temps

Résumé du poste

GMP Technologies seeks a Senior Manager, Quality - Lab Environment to lead the Quality department within a newly established laboratory in Singapore. The role will oversee QA, QMS, vendor oversight, batch disposition, and regulatory compliance to ensure lab operations meet global standards.

Responsibilities include driving quality strategy, managing a growing team, and guiding technology transfer for clinical material production, while coordinating with regulators and inspectors to uphold GMP

Qualifications

• 10+ years in Quality Lead roles in pharma/biotech/healthcare
• Extensive knowledge of quality systems, validation, and vendor management
• Strong leadership and communication abilities to influence cross-functional teams

Responsabilités

• Establish and oversee QA functions and QMS for lab programs and services
• Implement and maintain QMS to ensure compliance with policies and regulations
• Drive quality metrics and continuous improvement through management reviews
• Provide quality oversight for technology transfer during clinical material production
• Serve as Quality representative to regulatory authorities and inspections
• Lead talent development and build a high-performance quality organization
• Alert senior management to significant quality and compliance risks
• Collaborate with cross-functional teams to ensure GxP-compliant programs

Connaissances

Leadership

Communication

Problem solving

Critical thinking

Formation

Bachelor's or Master's in Science/Pharma

Description du poste

Senior Manager, Quality- Lab Environment

About the job Senior Manager, Quality- Lab Environment

Job Description: Head of Quality/Senior Manager

A newly established Laboratory is seeking a Head of Quality/Senior Manager to lead its Quality department. The role involves overseeing all aspects of Quality Assurance functions, including Quality Operations, Quality Management Systems, External Vendor Quality Oversight, Quality Supplier Management, Quality Compliance and Disposition, and Quality Control.

Key Responsibilities:

• Establish and oversee Quality functions and strategies for cell therapy programs and other services, including quality assurance, quality control, compliance, and batch dispositions.
• Implement and maintain Quality Management Systems to ensure compliance with applicable policies, standards, and regulations.
• Drive performance improvement and monitor the effectiveness of QMS by identifying and establishing key quality indicators for management reviews.
• Support cross-functional teams in ensuring clinical programs are conducted and reported according to current GxP, regulations
• Provide quality oversight for Technology Transfer requirements for clinical trial material production during the initial project phase.
• Lead and inspire a strong quality organization by attracting and developing talent and implementing talent development strategies within the organization.
• Serve as the Quality representative to regulatory authorities and third-party inspections.
• Alert senior management to significant quality and compliance risks.
• Perform other responsibilities as assigned by Senior Management.

Key Requirements:

• Bachelors or Masters Degree, or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent. Over 10 years of relevant work experience in a Quality Lead role in the pharmaceutical, biotechnology, medical device, or healthcare industry is preferred, with increasing people management responsibilities.
• Extensive knowledge of quality control, quality management systems, and validation requirements, preferably with third-party customer/supplier or vendor management experience.
• In-depth knowledge of regulations and industry guidance, with experience in technological transfer.
• Excellent communication and leadership skills, with a task-oriented approach.
• Strong critical thinking and problem-solving skills.