Manager Quality

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description The Commercial Quality, Manager ensures that all processes and product outputs meet the required quality standards. This role involves defining quality activities, auditing processes, and ensuring compliance with internal and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to deliver better health to people and a brighter future to the world. OBJECTIVES/PURPOSE:LOC Quality Manager 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 distribution quality, local Health Authority relationships, local quality surveillance, local contract manufacturing / packaging and in-country clinical activities.Works in collaboration with local cross-functional stakeholders with focus on patient’s needs, regulatory compliance and continuous improvement.Delegate for LOC Quality Head when required ACCOUNTABILITIES • Management of quality operations to ensure its compliance with local regulatory authority and Takeda’s global requirements for importation, local testing, product release, repackaging, 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, etc. • Ensure all relevant Quality support are provided for all relevant post market activities for Takeda India 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, field correction actions 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. • Support in establishing and maintaining 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 to ensure local Quality Council is conducted on a regular basis.• Monitor key performance indicators, evaluates and highlights any significant trends and identifies actions. • Support Establish and lead internal audit and lead self-assessment 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. • Secondary point of contact to manage relationship, relevant communication and inspection with local regulatory authority on GWP, GDP and Controlled Substances matters. Ensure regulatory commitments are duly completed on time • Delegated quality operations to ensure compliance to Clinical Quality Assurance for local clinical operations (as back-up).  • As Quality Business Partner with local stakeholders, ensure quality support to local business projects and product launches are successful 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. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge) • Good knowledge and experience as Quality Management Representative on the development, implementation and maintenance of a Quality Management System compliant to India regulatory requirements on Good Storage Practice (GSP) and Good Distribution Practice (GDP) and NMC corporate standards. • Strong in managing/performing quality operation activities and the regulatory requirements for the importation, repackaging, product release, storage and distribution of pharmaceutical products (including solid dose, biologics and cold chain). • Strong understanding with cGMP and quality management system elements and guidelines (e.g. PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging. Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change) • Ability to collaborate and partner well with cross-function stakeholders locally and regionally. • Organization agility (knowledgeable about how an organization works) and ability to lead change, deliver strong results and b