Purpose of the Role
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 assesses and addresses risks associated with storage and distribution of lifescience and healthcare products.
The role will also serve as the single point of contact (POC) for both internal teams and the customer, driving collaboration and continuous improvement.
Key Responsibilities
Regulatory and Certification Compliance
- Manage the application and maintenance of licensesfor the importation, wholesale and distribution of lifescicence and healthcare products, including controlled drugs.
- Act as the responsible person (RP) for implementing and maintaining an effective quality management system that meets GDP Standard and ISO13485
- Coordinate with clients and relevant functions for timely FSCA (Field safety corrective action) reporting to local health authority.
Governance of Quality Documents and Procedures
Establish Quality SOP / WI to support the regulatory and industry (eg. ISO13485) requirementsEstablish and maintain postponement activities such as kitting, labelling, redressing, repackaging etc.Support document control activities to ensure that documentation are timely review, revised, and archival of controlled documents in accordance with GDP requirements.Oversee qualification of warehouse (IQ,OQ,PQ), including temperature mappingSupporting the validation of processes, instruments, and software to ensure they meet quality requirements.Managing and reviewing changes to processes and procedures to ensure they do not compromise quality.Oversee the proper functioning of temperature and environmental monitoring systems in storage areas.Managing deviations from standard procedures, investigating their causes, and implementing effective corrective and preventive actionsSupport risk assessments for storage and distribution processesMaintain training matrices and records; monitor compliance with required training.Lead and oversee internal and external audit programs to ensure compliance with applicable regulations and standards.Continuous Improvement
Track and report on quality related KPI reporting (eg, CAPA closure timeline, etc)Provide recommendations for continuous improvement in quality systems, operational procedures, departmental processes, and client work instructions.Respond to temperature excursions and environmental deviations, including investigation, documentation, and CAPA implementation.Required Skills, Experience and Competencies
Qualification & Experience
Possess a Degree in Science or other relevant fieldsMin 5 years of work experience managing QMS systems and compliance, including in operational Lifesciences and Healthcare environmentDemonstrable experience managing Quality systems and compliance to Goods Manufacturing Practice (GMP), Good Distribution Practices (GDP), and ISO13485 standards.Strong interpersonal and communication skills with the attributes of a team player and a keen eye for detailsProven ability to collaborate, influence and work effectively with internal teams, customer stakeholders and external vendor partners to drive the required business outcomesRegistered Pharmacist in Singapore and willing to be a license holder for SG Lifescience Healthcare facilities will be an added advantageKey Competencies
Proven leadership, problem-solving, assessing and managing risk, and QMS management skills.Methodical, well organized and process orientedExcellent communication and interpersonal skills.Strategic thinking with attention to details.Highly motivated, self-starter demonstrating ability to use initiative with respect to scheduled work activities