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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.

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