Quality Manager

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Job Description

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

• 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:

• 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 build the confidence of stakeholders
• Ability to coach and elevate capabilities of peers and stakeholders.
• Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed
• Execute goals and objectives in a driven and a high-performance culture with ability to achieve results
• Delegate for LOC Quality Head, when required.

Decision-making and Autonomy:

• Anticipate potential problems and risks related to quality systems/regulatory expectation, assess potential impact, implement compliant solutions to issues.
• Responsible for timely execution of local market actions and Health Authority communications once a global decision had been aligned. 

Interaction:

Internal

• Key interactions with local key stakeholder groups to stay connected with business and respond to business needs.
• Key interactions across manufacturing and Quality regional and operating unit teams & other quality functions to enable timely issue resolution

External

• Manage relationship and communication with local regulatory authority on GWP, GDP and Controlled Substances matters.
• Key interactions with external GxP suppliers / distributor partners / clinical research organization (as identified) to maintain good quality support.

Innovation:

• Understanding of local industry, scientific and regulatory trends, and its market conditions and requirements.

Complexity:

• Multiple external suppliers, supply & distribution models, regulatory frameworks, local clinical study and medical device requirements, and a wide diversity of products.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Minimum 10 years’ experience in Pharmaceutical Company in quality function
• Experience in managing GxP supplier audits, internal audits, regulatory authority inspections.
• Ability to work independently and identify compliance risks and escalate when necessary
• Strong sense of urgency
• 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

Core Competencies / Skills

• Critical Thinking
• Investigation and problem solving
• Strong communication and stakeholder management skills
• Ability to influence and work effectively with local cross-functional team
• Agility and ability to manage complexity & balance priorities
• Risk identification, evaluation, and management.

Leadership Behaviors

• 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.

ADDITIONAL INFORMATION

• Domestic travel as required up to approximately 20%

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