Commercial Quality Lead, Poland

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OBJECTIVES/PURPOSE

The Commercial Quality Lead 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.

How you will contribute:

• Provide strategic and managerial leadership to Quality, GDP responsible Personnel. Contribute to the achievement of business success.
• Responsibilities cover GDPs-regulated activities including in-country distribution quality, Takeda warehouse, local Health Authority relationships, local quality surveillance, local contract manufacturing / packaging / analytical testing quality oversight, and in-country clinical and medical device activities.
• Ensure strong cross-functional collaboration 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 Commercial Leaders & stakeholders in the Poland LOC on quality matters and initiatives.
• Manage large projects or processes with limited oversight

ACCOUNTABILITIES

• Manage GxP regulated activities in LOC Poland to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products (including narcotics) to patients in a timely manner.
• Fulfil Responsible Person duties and oversee GDP requirements in Takeda Pharma Wholesale warehouse according to the Polish regulations and internal company requirements.
• Ensure and supervise a process for release of all received products to the distribution. Lead and perform/deputize the activities of Responsible Person and Local Narcotics Responsible Person.
• 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.
• Manage of realization reporting system ZSMOPL and serialization requirements.
• Ensure all relevant LOC colleagues performing GxP/quality-related tasks are appropriately trained prior to performing activities.
• Implement Supplier Quality Program at LOC Poland 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.
• 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. 
• 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 other Takeda entities (e.g. manufacturing sites, TEC), as applicable.
• Lead regulatory surveillance & intelligence in the LOC Poland 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.
• Strengthen Quality Culture at LOC. Champion a culture of continuous improvement and implementation of best practices.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Scientific degree (BSc, MSc)
• On job experience in pharmaceutical company in the last 5 years.
• Advanced in Quality Assurance, capable of handling highly complex situations, making improvement recommendations, and guiding others.
• Deep understanding of EU and local laws, regulations and Industry codes related to QA.
• Experience of working in a matrix management environment.
• Ability to lead teams in a local and international environment. Experience includes successful examples of managing and leading by influence and conflict management.
• Fluent in written and spoken English.

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 (re-turns, recalls, complaints), and contract manufacturing quality oversight.
• Meet other Legal local requirements for being Responsible Person (RP) and Narcotics Responsible Person

Core Competencies / Skills

• Applies advanced decision-making skills to complex situations, provides recommendations, and mentors others in decision-making processes
• 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

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 providing superior results.
• Elevating capabilities for now and the future.

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Employees may be eligible for a comprehensive range of benefits and incentives:

• short-term incentives

• Sport cards

• private medical care subscription

• group life and accidental death insurance

• participation in Employee Capital plans (PPK)

•  social found benefits

• Well-being benefits and others  

Pracownicy mogą być uprawnieni do szerokiego zakresu świadczeń i benefitów:

• system bonusowy

• karty sportowe

• opieka medyczna

• grupowe ubezpieczenie NŻ I NW

• udział w pracowniczych planach kapitałowych (PPK)

• benefity z ZFSS

• well-beingowe benefity oraz inne