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