SENIOR MANAGER - QA (LAB, VALIDATION & CALIBRATION)

Overview:

The incumbent is responsible for managing and overseeing quality assurance operations and/or inspection related to laboratory operations (Incoming, In-process) as well as Validation & Calibration. The incumbent is also responsible for ensuring that all processes comply with relevant standards and regulatory requirements while optimizing operational efficiency. Additionally, the incumbent is tasked with managing department’s operational costs and budgets.

Duties & Responsibilities:

Business Operations

• Oversee the day-to-day operations in the laboratory, validation and calibration, with support from the QA Manager and Assistant Managers.
• Assist the GM to communicate, implement, and monitor the implementation of all strategic planning and improvement initiatives (short, medium, and long term).
• Develop solutions for troubleshooting analytical methods and lead continuous process and quality improvements.
• Identify non-conformance trends, conduct technical investigations, and initiate corrective actions.
• Proactively identify gaps or issues and implement effective solutions in a timely manner.
• Ensure processes are clearly defined through Work Instruction (WI), Procedures, workflow, and other reference documents.
• Focus on the following key areas regarding processes under the scope of work:
• Review and improve documentation for accuracy, completeness and relevance.
• Ensure clarity in requirements and specifications that are easily understood by all stakeholders.
• Define clear workflows, roles, responsibilities (PICs), and escalation with identified lead times for timely responses.
• Review and refine the structure of QA operations to improve effectiveness and efficiency.
• Generate process and product capability reports using Statistical Process Control.
• Ensure the efficient use of resources.
• Propose, cascade and execute KPIs aligned with corporate goals and objectives.
• Ensure systems, processes, and specifications meet customer and regulatory requirements.
• Address CAPA deficiencies from audits, noncompliance in the processes or shipment, or customer complaints; focusing on effective corrective actions and sustainable preventive measures.
• Develop, implement, and maintain systems and programs to ensure products meet quality and regulatory standards, with a focus on early detection during incoming, in-process, and validation stages.
• Provide timely feedback on manpower, performance, and training requirements for Laboratory, Validation and Calibration sections.
• Manage operational costs and departmental budgets.
• Undertake additional tasks as assigned by superiors.

Lab Management

• Plan, coordinate and oversee all laboratory activities, including incoming, in-process, microbiology and equipment maintenance to ensure smooth and efficient operation.
• Ensure lab practices comply with regulatory requirements, standards and internal SOP/WI.
• Collaborate with production, validation, R&D, and pre-shipment team to deliver accurate and timely lab results.
• Oversee the calibration, maintenance, and qualification of lab equipment to ensure reliability and accuracy.
• Drive continuous improvements by evaluating existing laboratory processes and identifying efficiency gaps.

Validation & Calibration

• Oversee validation processes and calibration of instruments, equipment, and systems to ensure consistent product quality and operational efficiency.
• Lead the development and execution of validation strategies to ensure product quality and compliance.
• Oversee the preparation and maintenance of validation protocols, reports and change control documentation.
• Enhance validation protocols to improve efficiency, reduce deviations and support scalability, while ensuring timely and accurate documentation.
• Develop, implement and maintain a robust calibration program to ensure equipment / instrument operates within specified tolerance, maintaining accuracy and compliance with standards and regulations.
• Continuously evaluate validation and calibration processes to identify inefficiencies or gaps and recommend improvements.

People / Stakeholder Management

• Lead operations teams to achieve departmental and organizational goals.
• Ensure all levels of QA operations clearly understood their roles & responsibilities and are well trained in skills and knowledge.
• Build strong working relationships with stakeholders within the organization to achieve objectives.
• Manage recruitment, resource allocation, and deployment as needed.
• Oversee staff performance and career development initiatives.
• Coach and mentor subordinates to enhance skills, competencies, and knowledge.

Job Requirements:

Education:

• Bachelor’s degree and/or Master’s in Engineering and Science.

Work Experience:

• Minimum 10 years of working experience in a manufacturing environment, specifically in Laboratory Management and Process Validation.
• At least 4 years of experience in a managerial role.

Technical and Professional Knowledge:

• Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
• Extensive hands-on knowledge and experience in quality standards and regulations related to medical devices, including FDA QSR requirements (21 CFR 820), EU MDR, ISO 2859 (Sampling Procedures for Inspection), ISO 13485, ISO 14971 (Risk Management Assessment) and ISO 9001.
• Strong problem-solving, data analysis skills, including proficiency in statistical analysis tools such as Minitab and continuous improvement methodologies.
• Proven ability to lead teams, resolve conflicts, and drive accountability.
• Excellent communication and documentation skills.
• Well-verse in lean manufacturing concepts and operational excellence methods and best practices.
• Expertise in work planning and scheduling, including of operational and manpower planning.