Job Information
Takeda Pharmaceuticals Associate QA Manager in Manila, Philippines
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Job Description
Primary Purpose of the Job
- The Associate Quality Assurance Manager is responsible for ensuring that all quality assurance activities of Takeda Healthcare Philippines, Inc. are in compliance with the quality requirements in the conduct of its business. The job requires the person to assure and maintain the quality of products and processes, including standard procedures, quality audits/review.
Key Responsibilities and Accountabilities
Overall
Work towards vision and priorities of Takeda and ensure team engagement through effective communication and involvement in strategy development
Complete relevant reports within designated timeframes (e.g. expenses, monthly / quarterly reports, etc.)
Handle multiple priorities to achieve long and short-term goals
Implement and monitor the Quality Management System (QMS) within the LOC
Establish, monitor, and coordinate implementation of the Quality Plan
Quality Assurance
Implement the Quality Plan in Philippines.
Lead the Quality Council in the LOC.
Conducts, coordinates and monitors training of personnel in QMS
Enhances awareness on quality for all personnel
Establishes and maintains Quality Agreements with third party distributors and suppliers in Philippines
Maintains process to ensure that products being released are of good quality
Maintains process to ensure that damaged and expired materials are properly destroyed
Ensures that product and process deviations, out-of-specifications (OOS), complaints, and recalls are reported, investigated, resolved, and documented properly
Checks the quality of packaging materials, from artwork development up to the finished product
Organizes / lead 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
Ensures that GxP SOPs, JDs, and CVs are aligned with QMS standards
Ensures proper documentation and archiving of QMS documents, along with maintaining traceability
Ensures gap assessment on global procedures applicable to the LOC is completed in a timely manner
Reviews adverse event reporting made by the Pharmacovigilance team on a monthly basis by conducting random check
Good Manufacturing Practice
Audits third party distributors and suppliers, ensuring adherence to GMP / GDP, and QMS 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
Undertake QA activities in accordance with agreed business priorities to optimize commercial success for the business
Keep abreast of QA developments and guide internal stakeholders on local guidelines and practices
Patient-Centricity
- Provide QA support to internal stakeholders as expected in Takeda’s global standard operating procedures (SOPs) and policies
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 and RA 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 quality authority and partners to ensure optimal stakeholder management and LOC support
Cross-functional Collaboration
Cultivate excellent working relationships with other departments (in particular commercial, medical affairs, market access, pharmacovigilance, supply chain, compliance, legal and finance) and senior management
Implement strategies in collaboration with key internal stakeholders to support early submission and approvals in accordance with agreed quality plan
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
Have in-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical and medical devices
Knowledge in local regulations regarding Licensing and Product Registration
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 Associate Quality Assurance Manager is expected to conduct herself in line with the company culture and Takeda-ism.
Locations
Manila, Philippines
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Takeda Pharmaceuticals
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