Quality Assurance Manager

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Job Description

PURPOSE OF ROLE:

• Oversees all GxP aspects of LOC Quality operations to ensure compliance with local regulatory requirements and Takeda’s Quality Management Systems.
• Responsibilities cover GxP-regulated activities including in-country testing, in-country distribution, local Health Authority relationships and local quality surveillance.
• Works in collaboration with local cross-functional stakeholders with focus on patient’s needs, regulatory compliance and continuous improvement.

ACCOUNTABILITIES

• Management of quality operations to ensure its compliance with local regulatory authority and Takeda’s global requirements for importation, local country testing, product release, storage and distribution of Takeda products.
• Develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as per local regulatory authority and Takeda’s global requirements. These include but are not limited to: Change Control, Deviation, CAPA management, Training, Document Management, Complaint Handling, Gap Assessment, Self-inspection etc.
• Ensure all relevant Quality support are provided for all relevant post market activities for Takeda Vietnam and are executed timely as per local regulatory authority and Takeda’s global requirements to minimize any product supply interruption (e.g. support relevant document and communication preparation for local regulatory authority on product testing and recall).
• Initiate Quality Incident Notification to Management / escalation report for notifiable events in accordance with Takeda Global Procedure. Execute local recall/market action once the decision is endorsed by Market Action Committee (MAC) and ensure timely completion of the required actions.
• Responsible for local risk register. Engage the key LOC stakeholders to proactively identify GxP quality risk areas, and establish appropriate risk mitigations and risk monitoring program at the LOC.
• Responsible for local Quality Council. Monitors key performance indicators and highlights any significant trends and identifies mitigation actions.
• Support internal audits and lead self-inspection program at the LOC, to evaluate compliance with product quality systems & processes and to identify improvement opportunities.
• Lead the quality oversight of GxP supplier management, customer and distributor qualification and lifecycle management. Lead or participate in quality audits, & support QA due diligence of new business partners. Establish and maintain internal and external Quality Agreements.
• Primary point of contact to manage relationship, relevant communication and inspection with local regulatory authority on GSP matters. Ensure regulatory commitments are duly completed on time
• As Quality Business Partner with local stakeholders, ensure quality support to local business projects and product launches are successfully delivered in adherence to quality and regulatory compliance.
• Drive and strengthen the Quality Culture at the LOC
• Provide support to other countries’ quality operations if needed.

EDUCATION AND SKILLS: 

• Minimum 10 years’ experience in Pharmaceutical Company in quality function
• University Degree or Bachelor of Science Degree in Pharmacy or Industrial Pharmcy.
• Experience in managing GxP supplier audits, internal audits, regulatory authority inspections.
• Ability to work independently and identify compliance risks and escalate when necessary.
• Ability to manage complex projects and timelines in a fast environment
• Demonstrated interpersonal skills including strong negotiation skills
• Excellent teamwork and coordination skills
• Excellent verbal and writing skills and fluent in English and as applicable, local language is desired
• Experience as Chief Pharmacist or deputy Chief Pharmacist role.

COMPETENCIES:

• Good knowledge and experience on the development, implementation and maintenance of a Quality Management System compliant to Vietnam regulatory requirements on Good Storage Practice (GSP) and Good Distribution Practice (GDP)
• Strong in managing/performing quality operation activities and the regulatory requirements for the importation, in-country resting, product release, storage and distribution of pharmaceutical products.
• Strong understanding with cGMP and quality management system elements and guidelines (e.g. PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product.
• Strong understanding of local industry, scientific and regulatory trends, and its market conditions and requirements.
• Experience in quality auditing of GxP suppliers

BEHAVIORAL

• Strong communication and stakeholder management skills. Ability to collaborate and partner well with cross-function stakeholders locally and globally.
• Key interactions across manufacturing and operating unit teams & other quality functions to enable timely issue resolution
• Enhanced enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Creating an environment that inspires and enables people.
• Focusing on the few priorities and provide superior results.
• Elevating capabilities for now and the future.

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