Ref.number: SQH/11/2016

Objectives:

We are looking for a strong candidate for the position of Site Quality Head at the Takeda manufacturing site in Lyszkowice and Commercial Quality Head for Poland.

The employed person will be responsible for decision making on QA, QC & Quality Compliance issues.

As a member of Site Leadership Team and a Leader of local site Quality Council will be responsible for collaboration with Site Leadership to achieve site business objectives and review of metrics/KPIs.

Activities and Responsibilities:

• Site Quality Head for manufacturing site in Lyszkowice (products for local commercialization and export)
• Commercial Quality Head for all products commercialized in Poland (imported and local manufactured products)
• Decision maker on QA, QC & Quality Compliance issues
• Member of Site Leadership Team
• Collaboration with Site Leadership to achieve site business objectives
• Leader of local site Quality Council including review of metrics/KPIs
• Aligns with Site Leadership on people selection and budget
• Conducts performance management & development of site Quality people
• Qualified Person (preferred)
• Assure compliance with national and international legal requirements and TAKEDA Quality Management System
• Primary contact person for national and international authorities
• Assure the Takeda job safety rules are followed within the department
• Ensure that department complies with legal, company and customer EHS requirements
• Integrate EHS Management System into the overall management of department
• Continuously improve EHS system and performance
• Set EHS management objectives and targets and ensure that they are integrated into the business plan
• Monitor the overall EHS performance of the department against targets
• Review and ensure implementation of CCO EHS performance metrics at a local level
• Ensure that line managers are meeting their EHS responsibilities
• Ensure that employees are informed about relevant EHS matters and their actual and potential impact on the site’s operation
• Leadership role model for Takeda-ism, Leadership behaviors and Quality Culture

Detailed range of responsibilities:

The main responsibility of the Site Quality Head is to assure proper functioning of the quality management system at manufacturing plant of Takeda Pharma Sp. z o.o. in Lyszkowice, Poland.

Detailed responsibilities:

• Organization of Quality Management System with regard to manufacturing of medicinal products, importation and distribution of active pharmaceutical ingredients
• Establishes processes to assure compliance with internal and external regulations
• Leads local compliance program
• Demonstrated ability to anticipate potential problems and risks related to quality systems expectations and regulatory compliance with ability to formulate action plans and implement solutions
• Proven leadership
• Organization of work of reporting staff
• Reporting to superior and company Board about issues concerning functioning of quality management system, other non-compliance and quality problems
• Authorising quality agreements with business partners
• Supervision over archiving of documentation from production and quality control
• Assuring preparation of Quality Management Review
• Maintenance of manufacturing licence

Requirements:

• High technical education (medical analytics, biology, biotechnology, chemistry, pharmacy, medicine)
• Minimum 10 years of work experience in a relevant role in a pharma manufacturing company
• The requirements of the polish low regulations regarding Qualified Person
• Broad practical knowledge of quality management system
• Very good command of English
• Strong commitment and motivation to achieve results
• Good organizational skills
• Ability to work with a high level of independence
• Strong sense of responsibility and ability to work on own initiative
• A proactive attitude and problem solving skills
• Ability to creating the environment that inspires and enables people to collaborate and move the organization forward