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Job Description

ABOUT THE ROLE:

• Support the achievement of business success with regards to GDP and quality related activities in the LOC.
• Responsibilities cover GxP-regulated activities including in-country distribution quality, local Health Authority relationships, local quality surveillance, local packaging / analytical testing quality oversight, and quality oversight of local GCP/GVP/Devices/Medical related activities, as applicable.
• Work in collaboration with other GxP and non-GxP functions focusing on patient’s needs, regulatory compliance, as well as internal standards and SOPs and continuous improvement.
• Serves as the Quality point of contact with key stakeholders in the Hungary LOC on quality matters and initiatives.

HOW YOU WIL CONTRIBUTE:

General

• Employee is obliged to work in accordance with applicable legislation and Takeda’s internal requirements and processes

COMMERCIAL QUALITY

• Manage GxP regulated activities in Hungary LOC to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner.
• Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs) that are aligned with local requirements.
• Implement Takeda QMS and ensure ongoing compliance to the quality standards and procedures at the LOC. These include but are not limited to: change control, deviation, CAPA management, training, document management, complaint handling, etc.
• Develop and maintain GxP related controlled documents in the LOC Quality Management System.
• Ensure that LOC QMS is implemented and aligned with the needs of the organization, including a contribution for development and review of QMS documents. Track and assess if local documents are compliant with local/global GxP requirements and arrange for necessary actions, such as consultation with subject matter experts and creation/update of processes and applicable training.
• Ensure all relevant LOC colleagues performing GxP/quality-related tasks are appropriately trained prior to performing activities.
• Implement Supplier Quality Program at Hungary LOC according to Takeda Global Quality requirements and regulatory expectations. Establish and maintain local GxP supplier quality agreement. Ensure new local GxP supplier/contractor audited and qualified before use, as applicable.
• Ensure local Quality Council on a regular basis, monitor and report key performance indicators (KPIs) according to Takeda Global Quality requirements.
• Perform self-assessments to monitor compliance with applicable procedures and requirements.
• Manage inspections/audits and ensure LOC audit/inspection readiness.
• Lead or support local Health Authority communication on product quality issues.
• Support local process for first batch notification to Health Authority
• Collaborate with Pharmacovigilance for periodic reconciliation of product complaints and AEs/SSRs
• Maintain oversight of contracts and quality agreements on LOC level.
• Support the preparation of external quality agreement between business partners (distributors and/or customers) and Trading Entity and/or Manufacturing release sites, as applicable.
• Lead regulatory surveillance & intelligence in the Hungary LOC for new or emerging regulations.
• Ensure there is quality oversight of local GCP/GVP/Devices/Medical related activities, such as for local studies (e.g., Investigator Initiated Trials (IITs), Collaborative studies, Interventional studies (NI), Non-Interventional Studies (NIS)) & activities impacting the PV system, e.g PV, Regulatory Affairs activities, as applicable.
• Strengthen Quality Culture at LOC. Champion a culture of continuous improvement and implementation of best practices

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Strong knowledge of the regulations in the Geographic Scope and EU.
• Deep understanding of LOC/Commercial Quality requirements, including in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (returns, recalls, complaints).

Leadership

• Ability to collaborate and partner well locally, within MCO EE Q-Team & cross-functionally with stakeholders.
• Ability to drive change by influence.
• Strategic enterprise thinking, finding innovative ways to serve patients, build reputation and trust.
• Delegate for Area Head Commercial Quality MCO EE.

Decision-making and Autonomy

• Responsible for resource management within the Hungary LOC Quality including budget responsibility.
• Responsible to anticipate potential problems and risks related to quality system / regulatory expectations and implement solutions.
• Responsible for timely execution of market actions and Health Authority communications in Hungary once the decision had been aligned. 

Interaction

• Key interactions with LOC and MCO EE QA colleagues to improve performance & maintain compliance
• Key interactions with LOC leaders/GMs and other key stakeholder groups including Regulatory Affairs to stay abreast with business and LOC strategy and respond promptly to evolving business and QA resourcing needs.

Innovation

• Understanding of industry, scientific and regulatory trends in the Geographic Scope, and its market conditions and requirements.

Complexity

• Regulatory framework, clinical study and medical device requirements, and a wide diversity of products, as applicable

WHAT YOU BRING TO TAKEDA:

• Scientific degree (BSc, MSc)
• On job experience in pharmaceutical company in the last 5 years.
• Experience and proven track record in quality assurance and deep understanding of EU and local laws, regulations and Industry codes related to QA.
• Experience of working in a matrix management environment.
• Managing and leading by influence, conflict management.
• Fluent in written and spoken English and Hungarian.

Core Competencies / Skills

• Critical Thinking
• Investigation and problem solving
• Good communication and stakeholder management skills
• Ability to manage complexity & balance priorities.
• Risk identification, evaluation, and management.
• Continuous improvement / appetite for continuous learning

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.

ADDITIONAL INFORMATION

• Travel across LOC as needed, MCO and other EU countries (for training if needed)

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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