Lifescience Healthcare (LSH) Quality Assurance Manager - (7502)

BDP International; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading logistics company is looking for an LSH Quality Assurance Manager in Singapore. The role involves ensuring compliance with quality regulations in the Life Sciences and Healthcare sector, managing risks, and fostering collaboration. The ideal candidate will have a strong background in quality management systems and relevant experience in the industry.

Qualifications

• 5 years of experience managing QMS and compliance in Life Sciences and Healthcare environments.
• Registered Pharmacist in Singapore preferred.
• Experience with GMP, GDP, and ISO 13485 standards is required.

Responsibilities

• Manage licenses for importation and distribution of life sciences products.
• Establish Quality SOPs to support regulatory and industry requirements.
• Lead internal and external audits for regulatory compliance.

Skills

Leadership

Problem Solving

Risk Assessment

QA Management

Communication

Education

Degree in Science

Job description

Lifescience Healthcare (LSH) Quality Assurance Manager - (7502)

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Job Title: Lifescience Healthcare (LSH) Quality Assurance Manager

Education: Bachelor's Degree

Location: Singapore

Category: Operations

Job Type: Permanent

Job Description

PSA International is a leading port group and trusted partner to cargo stakeholders. PSA actively collaborates with its customers and partners to deliver world-class port services, develop innovative cargo solutions, and co-create an Internet of Logistics.

PSA BDP focuses on supporting cargo owners to ensure their supply chain is resilient, agile, sustainable, and cost-efficient. We operate a global network of digital solutions to simplify logistics and build trustful relationships.

We are seeking a highly capable LSH Quality Assurance Manager to ensure strong quality governance for a key Life Sciences & Healthcare customer in Singapore. This position is responsible for ensuring quality excellence, compliance with industry regulations, delivering customer satisfaction, and assessing and addressing risks related to the storage and distribution of life sciences and healthcare products.

The role will also serve as the single point of contact (POC) for both internal teams and the customer, promoting collaboration and continuous improvement.

Key Responsibilities

Regulatory and Certification Compliance

• Manage licenses for importation, wholesale, and distribution of life sciences and healthcare products, including controlled drugs.
• Act as the responsible person (RP) for implementing and maintaining an effective quality management system that meets GDP standards and ISO 13485.
• Coordinate with clients and relevant functions for timely FSCA reporting to local health authorities.

Governance of Quality Documents and Procedures

• Establish Quality SOPs and Work Instructions to support regulatory and industry requirements.
• Manage activities such as kitting, labeling, redressing, and repackaging.
• Support document control activities, ensuring timely review, revision, and archiving of controlled documents in accordance with GDP requirements.
• Oversee warehouse qualification (IQ, OQ, PQ), including temperature mapping.
• Support validation of processes, instruments, and software to meet quality standards.
• Manage changes to processes and procedures to ensure quality is maintained.
• Oversee temperature and environmental monitoring systems in storage areas.
• Investigate deviations, implement corrective and preventive actions, and manage risk assessments for storage and distribution processes.
• Maintain training matrices and records; monitor compliance with training requirements.
• Lead internal and external audits to ensure regulatory compliance.
• Track and report quality KPIs, such as CAPA closure timelines.
• Recommend continuous improvements in quality systems, procedures, and instructions.
• Respond to temperature excursions and environmental deviations, including investigations and CAPA.

Job Requirements

Qualifications & Experience

• Degree in Science or relevant fields.
• Minimum 5 years of experience managing QMS and compliance in Life Sciences and Healthcare environments.
• Experience with GMP, GDP, and ISO 13485 standards.
• Ability to collaborate effectively with internal teams, customers, and vendors.
• Registered Pharmacist in Singapore; willingness to hold a license for SG Life Science Healthcare facilities is an advantage.
• Strong leadership, problem-solving, risk assessment, and QA management skills.
• Methodical, organized, and process-oriented.
• Excellent communication and interpersonal skills.
• Strategic thinker with attention to detail.
• Motivated, proactive, and able to take initiative.