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Job Description
Primary Purpose of the Job
The Quality Assurance Manager is responsible in ensuring that all quality related activities of Takeda Healthcare Philippines, Inc. are in compliance with the local regulatory and statutory requirements in the conduct of its business. In addition, the job required the person to assure and maintain the quality of products and processes, including standard procedures, quality audits/review.
Key Responsibilities and Accountabilities
Implement Takeda QMS and ensure on-going compliance with quality standards and procedures.
Implement the Quality Plan in Philippines.
Ensure Quality Council is conducted at the LOC.
Provides Supplier Quality Management and oversight in accordance with Takeda Supplier Quality Management requirements. These would encompass the selection & qualification of new suppliers, ongoing quality performance monitoring and exit of suppliers which provide materials and services with GxP/product quality impact. Ensure new GxP suppliers/contractors are audited and qualified before use. Lead or participate in quality audits, & support QA due diligence of new business partners according to local regulatory requirements
Accountable and oversee the management of local Quality activities to support Quality operations. Quality activities include but not limited to: product release, complaints handling, deviations, change controls self-inspection, trainings, control of GxP documentation, quality risk management, in-country testing requested by health authority, support new product launches, quality oversight of local GMP/GDP activities etc.
Local release: Ensure batch release is in compliance with local regulatory requirements and local procedure prior to distribution.
Evaluate returned goods and ensure that damaged and expired materials are properly destroyed
Checks the quality of packaging materials, from artwork development up to the finished product
Organizes / partakes in internal audits (self-inspection) in cooperation with other functions
Ensures that changes with impact on quality, safety, and registration status of products are being reviewed, approved, and authorized prior to implementation
Ensure all relevant LOC colleagues performing GxP quality-related tasks are appropriately trained prior to performing activities.
Ensures proper documentation and archiving of QMS documents, along with maintaining traceability
Ensures gap assessment on global procedures applicable to the LOC is being done timely
Reviews adverse event reporting made by the Pharmacovigilance team monthly by conducting random check
Performs other tasks and duties which may be assigned by the immediate supervisor from time to time
Provide quality expertise and resolution of all product quality issues originating in the LOC in conjunction with other functions (ie. Regulatory Affairs, Medical, Business Unit, GMS). Timely escalation of reportable events in accordance with Takeda Global process.
Participate and lead the implementation of integrated GxP enterprise systems.
Influence LOC Quality strategy cascaded from Global Quality Roadmap and align to LOC Business Plan.
Drive and strengthen the Quality Culture
Good Manufacturing Practice
Audits third party distributors and suppliers, ensuring adherence to GMP / GDP, QMS, and regulatory requirements
Supervise testing methods and repackaging of products as approved by FDA and ensures compliance with GMP and ASEAN requirement of toll manufacturers
Strategic Planning
Patient-Centricity
People Management
Contribute toward building a performance-based culture that leads to operational excellence within the QA Department
Promote teamwork and boost overall team morale
Corporate Governance and Quality Management System
Comprehend and drive Takeda’s operational procedures and policies
Create and implement departmental standard operating procedures for QA activities and ensure compliance with relevant corporate / department policies / procedures
Support internal/external audits and implementation of corrective actions when applicable
Maintain up-to-date knowledge of Takeda’s standard operating procedures and guidelines
Ensure timely training of applicable SOPs and retain training records
External Stakeholder Management
Participate in local authority inspections and internal audits, as applicable
Foster strong working relationship with local regulatory authority to ensure optimal stakeholder management and LOC support
Cross-functional Collaboration
11 Qualification Requirements
Bachelor of Science Degree in Pharmacy or Industrial Pharmacy
Pharmacy professional license holder
A minimum of 5 years of relevant QA expertise in the pharmaceutical industry
Competencies Required
Demonstrated leadership and strategic planning skills
Performed successfully within a team environment and as an individual contributor with the ability to work in a matrix environment
Proficient practical application of QMS knowledge to drive improvements
Strong understanding of linkages and interrelationships between different QMS elements, and able to effectively integrate quality data sources
Good knowledge of ICH Q10 requirements, and application to LOC operations (CC, QMR, Deviations, CAPA, Knowledge Management, Management Review etc
Ability to communicate effectively with senior management
A mind-set of continuous improvement, innovation and be solution-focused with strong problem-solving ability
Ability to assess and make risk-based decisions while keeping stakeholders appraised
Experienced in assessing a situation, identifying issues and developing solutions that result in efficiencies or process improvements
Ability to work with a sense of urgency, prioritize work, meet objective / deadlines with strong organizational capability
A sense of commercial acumen and have met department goals within specified timelines
Excellent negotiation, project management, verbal and written communication skills in English
Knowledge in local regulations regarding Licensing
Background in Good Manufacturing Practices
Microsoft Office Skills (in particular MS Word, MS Excel, MS PowerPoint)
Ability to plan, organize and prioritize
This job description defines and captures key expectations. However, duties and / or roles are not limited to details above and may evolve or change during the course of the role based on the company priorities and manager’s discretion.
As with all Takeda positions, the Quality Assurance Manager is expected to conduct self in line with the company culture and Takeda-ism.
Locations
Manila, Philippines
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time