Senior Quality Specialist

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Job Description

About the role:

This role will be responsible for Quality activities in relation to Takeda Products commercial activities at Takeda Iberia Local Operating Company (LOC) which includes ensuring that a quality management system is implemented and maintained in accordance with the Guidelines on Good Distribution Practice for medicinal product for human use (2013/C 343/01); with local and relevant international regulations, local and international legislations, ISO 14001 requirements (in the case of TFE) and with Takeda policy.

Key activities of the role:

• In country Distribution Quality- Quality oversight of outsourced distribution partners

• Ensure the compliance of legal and corporate requirements, as well as the I-SOPs and Local SOPs.

• Establish corrective and preventive actions as requires and to promote the continuous improvement into the critical processes from quality point of view of the company.

• Local quality surveillance – connects with customers: Returns, market actions, complaints, inquiries.

• Local MOH relationship- Good Distribution Practices inspections & Work closely with RA in MOH communications

• Support geographic expansions and brand plan launches.

• Shipping Validation and Distribution processes quality oversight

• Contribution in the identification of risks in the quality area, CAPA proposal and follow up.

• Interaction with Local Stakeholders: Supply Chain & Customer service, Customers, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, Marketing.

How you will contribute:

Quality Management System:

• Batch release documentation of the company products (reviewing packaging materials for batches of products that are controlled substances or for which Takeda LOC is MAH and FMD compliance) to ensure the quality of Takeda products released including incidences and complaints solving.

• Training activities in the quality area and management of staff training record for the GxP positions

• Change Control & CAPA management and monitoring.

• Management Review Systems, Quality Council meetings. Collaboration in QMS maintenance

• Market action management

• Handling of Returns. Management of returned products to our local warehouse and destruction process through and authorized company.

• Control of damaged and broken products.

• Customer BonaFide

• Local Complaint Coordinator & management of counterfeit product.

• To resolve technical request of the products: storage, manipulation, expiry and administration.

• Responsible for Annual Environmental Declarations

• Control of free samples distribution and storage in accordance with national law.

• Supplier approval and maintenance.

• Ensure timely delivery of fully compliant products applicable to local Regulations. Import/Export requirements, manage temperature excursions and transport distribution deviations, Local Release, MoH local Plasma Product Release.

• Control of narcotics/controlled substances and hemoderivates according to National legislation. Management and authorization of narcotics vouchers and request for marketing authorization of blood products batches via AEMPS/INFARMED. Traceability of the Takeda products.

• Participation in internal audits and external audits and collaborate with CAPA plans follow up /audits closeout.

• To ensure implementation and maintenance of Quality Management System according to National legislation, corporate requirements and contribute with ISO 14001 requirements.

• Management of enquiries related to the technical/quality department.

• Artworks control sheets management when applicable.

• SOPs & Document management. Collaboration in Global procedures implementation at local level. Act according to Corporate, Compliance, Ethical codes and Legal standards

• Promotes, encourage and demonstrate commitment to Takeda-ism philosophy and values.

• Communicate to pharmacovigilance department any adverse reaction at the time of becoming aware of it, following company’s internal procedures.

• anagement of informatics systems used in Quality department (SAP, Trackwise, Veeva Vault, SAP Success Factors)

• Health Authorities communications to assure GDP compliance.

Quality Activities: Warehouse and Distribution Activities:

• Overseeing audit of the quality system on a regular basis, tracking and assisting in the closure of Internal (corporate and self-inspection) and External Audits 3rd party storage and distribution sites

• Prepare and review Local Quality Agreements and Warehouse and Distribution Agreements

• Accountable for Quality KPIs metrics

• Assist the Supply Chain Organization to ensure continuity of supply is maintained.

Additional Activities:

• Contribute to develop and strengthen global quality management systems and provide flexible support to business both at the country level and global level.

• Support to Quality Head/RPs within the country.

• Ensure inspection readiness in market.

• Support ongoing integration projects at Takeda associated with Distribution and Supply

Takeda Principles and Standards

• Act according to Compliance, Ethical codes and Legal standards.

• Ensure that Patient-Trust-Reputation-Business (PTRB) principles guide the planning and decision-making process. Promote, encourage and demonstrate commitment to Takeda-ism philosophy and values acting as role model driving a culture of integrity and speak up.

• Communicate to pharmacovigilance department any adverse reaction at the time of becoming aware of it, following company’s internal procedures

What you bring to Takeda:

• Bachelor’s Degree in Pharmacy

• Practical experience of at least 6 years in the Pharmaceutical Industry, a majority of which has been gained in a QA environment. Supply Chain knowledge is beneficial.

• Experience in supporting inspections from local authorities /global audits.

• Experience of working with suppliers and customers

• Experience in working in a global and matrix environment.

• Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team.

• Execute goals and objectives in a driven and a high-performance culture, and as applicable with ability to achieve results with non-direct reports.

• Organization agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence of stakeholders.

• Able to work with a great degree of autonomy, as part of a global virtual team

• Able to work cross-functionally and cross-culturally, in a global business environment.

• Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed.

• Able to adapt to changes and positively respond to changes.

• Enthusiastic, resilient, dynamic, versatile. Display 'Can do' attitude.

• Good interpersonal and communication skills

• Excellent verbal and writing skills and fluent in English.

• Strive to drives the business forward and look for practical and compliant solutions to issues.

• Understands total potential impact and contributes significantly to the solution of simple or complex issues arising.

• Expected to work with a number of suppliers / products.

• Provide a positive and solution-oriented environment.

• Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently.

• Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures.

• Uses own judgment to assess what to refer upwards and what to deal independently.

Knowledge:

• Good knowledge of Pharmaceutical Quality Management systems: EU GDPs, ISO standards, GMPs, , QM standards.

• Excellent knowledge of local GDP and Controlled Substances regulations, plus good awareness of other GMP requirements e.g. ICH, FDA

Takeda Core Capabilities

Takeda Leadership Behaviors:

• Clear demonstration of our leadership behaviors, as this is crucial for success in our organization: Think Strategically, Inspire Others, Deliver Priorities, Elevate Capabilities.

Digital Knowledge:

• Upskilling on everyday digital tools and platforms relevant to the position, including artificial intelligence (Eg. CRM, Portals, PowerBI) to boost efficiency, effectiveness, and excellence.

Data-Driven Decision Making:

• Proficiency in using facts, metrics, and data to guide business decisions adjusted to the role and to leverage insights for strategic planning.

• Clarity on data sources, management and analysis relevant to the role.

Agility and Adaptability:

• Ability to adapt quickly to change and embrace new business models, priorities and digital mindset.

• Drive for results. Result-oriented and able to develop plans/solutions and deliver expected results even in ambiguous circumstances.

• Increase efficiency and scalability by repurposing successful elements of existing solutions in the company.

Collaborative Mindset:

• Embracing a collaborative approach to problem-solving and innovation.

Continuous Learning:

• Embrace a life-long learning mindset and take ownership of learning journey, be proactive and build own development planning.

• Commitment to staying updated with the latest market trends, digital technologies, and best practices in the pharmaceutical industry.

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