Commercial Quality Lead, Ukraine

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Job Description

About the role:

• Lead the Ukraine Commercial Quality Team, fostering quality culture and continuous learning

• Oversee all GxP aspects of LOC Quality operations, ensuring compliance with local regulations and Takeda’s Quality Management Systems. 

• Responsibilities cover GxP-regulated activities including in-country distribution quality, local Health Authority relationships & inspection readiness/management, local quality surveillance, local contract manufacturing / packaging and in-country clinical and medical device activities.

• Act as the designated Qualified Person (QP) wholesale for Ukraine, ensuring adherence to GDP and local regulatory requirements for product importation and wholesale distribution. 

• Collaborate with cross-functional stakeholders as part of the Country Leadership Team, focusing on patient needs, regulatory compliance, and continuous improvement.

How you will contribute:

• Management of quality operations to ensure its compliance with local regulatory authority and Takeda’s global requirements for importation, product release, packaging, storage and distribution of Takeda products

• Responsible to 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.

• Provide quality expertise and resolution of quality issues originating in the LOC in conjunction with other functions (ie. Regulatory Affairs, Medical, Business Unit, GMS).

• 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.

• Manage and implement the annual quality priorities and improvement initiatives at the LOC in line with Region/Area/CQ objectives. This will include the following:

  • Establish and maintain the 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.

• Ensure local Quality Council is conducted on a regular basis.

  • Monitor Quality Key Performance Indicators, evaluates and highlights any significant trends and identifies actions with local business partner(s).

• Lead regulatory inspections at LOC for GxP activities and ensure regulatory commitments are duly completed on time

• Establish and lead internal audit / self-assessment program at the LOC, to evaluate compliance with product quality systems & processes and to identify improvement opportunities.

• Provide 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.

• Quality Business Partner with LOC cross-functions to support successful delivery of LOC business strategy, product launches 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.

Dimension and Aspects

Technical/Functional (Line) Expertise

• Strong in managing/performing quality operation activities and the regulatory requirements for the importation, repackaging, product release, storage and distribution of pharmaceutical products.

• Good knowledge and experience the development, implementation and maintenance of a Quality Management System compliant to local regulatory requirements on cGMP & Good Distribution Practice (GDP).

• Assume full responsibility as QP for product import and Wholesale, and execute quality decisions in compliance with local regulations and Takeda quality requirements

Leadership

• Ability to collaborate and partner well with cross-function stakeholders locally and regionally.

• 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

• Ability to lead a team, manage elevate organizational performance, by partnering with stakeholders.

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

• Key interactions with Country Leadership Team and other key stakeholder groups to stay connected with business and respond promptly to business and QA resourcing needs.

• Key interactions across manufacturing and Quality regional and operating unit teams & other quality functions to enable timely issue resolution

• Key interactions with LOC QA colleagues in region to improve team performance & continuous improvement

External

• Manage relationship and communication with local regulatory authority.

• Key interactions with external GxP suppliers / distributor partners to maintain good quality support.

Innovation

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

Complexity

• Complex business models, supply & distribution models, regulatory frameworks and a wide diversity of Innovative products.

What you bring to Takeda:

• Minimum 7-10 years’ Quality & Compliance experience in Pharmaceutical Company, preferably with prior experience in multinational pharmaceutical companies

• Education: Must have higher education of at least second (master's) level in the specialty "Pharmacy, industrial pharmacy," a specialist pharmacist's certificate issued by a post-graduate education institution, or a certificate on assignment (confirmation) of the relevant qualification category

• Required to possess Qualified Person wholesale license

• Preferred to also possess Qualified Person import license

• 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 and possesses 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

• Prior People Management experience preferred

• Prior experience in GVP/GCP will be preferred.

• Proficiency in leveraging digital technology to optimize quality processes, including experience with electronic quality management systems and digital documentation tools.

• Six Sigma Certification will be preferred.

• Strong proficiency in English – written and spoken.

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:

• International travel as required up to approximately 10%

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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