Quality Assurance Manager

• Join a leading multinational pharmaceutical company in the Philippines.
• Take the lead in establishing and shaping the Quality Assurance department.

About Our Client

The company operates in the pharmaceutical space, focusing on delivering top-quality products and services to its customers.

Job Description

• Collaborates with the Quality Assurance leadership team and management representatives in the design, development, implementation, and continuous improvement of the organization's quality management system (QMS).
• Manages and oversees validation and qualification programs in line with regulatory and industry standards.
• Analyzes and manages quality-related data to support informed decision-making and continuous improvement efforts.
• Supervises quality assurance personnel to ensure effective implementation of QMS policies and procedures across operational sites.
• Supports investigations and resolution of quality incidents and customer complaints in coordination with cross-functional teams.
• Ensures compliance with deviation and change management procedures.
• Conducts training on quality systems, procedures, and regulatory standards such as GMP, ISO 9001, and other applicable guidelines.
• Leads or supports environmental management system (EMS) initiatives and programs.
• Participates in internal audits and operational assessments to ensure compliance with quality and regulatory standards.
• Attends and supports internal, client, third-party, and regulatory audits and inspections, including preparation and documentation of corrective and preventive actions (CAPA).
• Coordinates with various departments to ensure timely submission and implementation of corrective actions. Supports preparation and facilitation of client and external audits when necessary.
• Assists in regulatory inspections and ensures compliance with government agencies and applicable licensing bodies.
• Acts as an internal auditor and supports audit planning, execution, and reporting activities.
• Ensures adherence to quality and regulatory requirements applicable to storage, distribution, and manufacturing operations.
• Leads or contributes to quality improvement programs by coordinating with project teams to implement process or system enhancements.
• Provides proactive recommendations to quality leadership to improve operational efficiency and overall quality performance.
• Ensures accurate and timely reporting of key performance indicators (KPIs) and other quality-related metrics to management.
• Performs data analysis and reporting to support continuous improvement initiatives.
• Reviews and approves quality documents and reports within assigned authority level.
• Prepares and submits required quality and compliance reports to management and external partners.
• Recommends policies, procedures, and process improvements to enhance the effectiveness and efficiency of the quality function.
• Performs other duties as assigned by quality leadership in support of departmental and organizational goals.

The Successful Applicant

• A bachelor's degree in a science-related field such as life sciences, healthcare, or a relevant discipline.
• At least 3-5 years of experience in quality assurance and management systems, with proven expertise in regulatory compliance, safety reporting, and risk management.
• Strong knowledge of compliance and regulatory standards.
• Excellent problem-solving and analytical skills.
• Proficiency in quality management tools and software.
• Leadership abilities to manage a team effectively.
• Exceptional communication and collaboration skills.

What's on Offer

• Competitive compensation package
• Be a trailblazer in setting up the Quality Assurance department from the ground up