- Establish and implement GWWO quality policy to assure compliance with Grifols Corporate Quality Policies ,EU and FDA Current Good Manufacturing Practices, and other applicable regulations, guidelines and practices related to the manufacture of the GWWO medicinal products.
- Ensure that Qualified Persons/Responsible Persons certify before release that each lot of product has been manufactured and tested in accordance with the requirements of its license (or marketing authorization) and the principles and guidelines of the Good Manufacturing Practices.
- Ensure that in case of any deviations or planned changes that all the additional verifications, checking and testing have been performed before the release of the lot and authorized by the persons responsible in accordance with the system defined. Also ensure that any changes requiring the variation to the license have been conveyed to and authorized by the relevant authority(ies).
- Approve the application and implementation of changes in the processes and facilities that affect the product, with the objective of evaluating their impact and documenting the change correctly. Ensure that any changes requiring the variation to the license are conveyed to and authorized by the relevant authority(ies).
- Ensure that the manufacturing and testing processes have been validated.
- Review and approve key documents from the Quality, Validation and Manufacturing departments to provide the required oversight, acceptance of operations task and compliance with the corresponding licenses and the GMP.
- Communicate with Competent Authorities (Ireland and international) and establish good working relationships with agencies that regulate company business.
- Coordinates activities of various GWWO departments whenever the recall is required.
- Oversight and management of all regulatory and customer inspections ensuring all relevant approvals obtained.
- Distribution and quality agreements review, approval and implementation in line with company product strategies.
- Manage and approve the budget and investments of the Quality Area (Quality Control, Quality Systems and Compliance and Quality Assurance) to assure correct performance of the work in these areas and implementation of improvements in Quality Systems and Quality Control in light of technical, scientific progress and changes in quality management.
- Ensure the implementation of appropriate training programs to maintain the levels of knowledge and experience in the performance of tasks in the Quality Area.
- Provide direct and clear communication to senior management and Corporate Quality regarding the current status of Quality and Quality Systems and Compliance within GWWO
- Collaborate with Grifols' other quality groups to establish uniform quality policies from a company-wide perspective.
- Supervise Mangers of the Quality Area (Quality Control, Quality Assurance and Quality Systems and Compliance), motivating and providing leadership and guidance in a manner that promotes a consistent approach to quality management for GBI.
- Implement global KPIs at site level to ensure quality and business objectives achieved, and oversight the timely application of the appropriate corrective mesures or CAPAs derived from the continuous evaluation of these KPIs if appropriate,e to correct trends or results outside the targets
- All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
- Strong understanding of biology, chemistry and microbiology scientific disciplines.
- Strong understanding of protein purification and aseptic filling processes.
- Excellent understanding of GDP and GMP regulations and guidelines
- Excellent understanding of suppliers' standards and guidelines
- Previous experience in managing teams
- A BSc / MSc in Science, pharmacy or related discipline
- A minimum of 10 years GMP/GDP experience
- Excellent communication skills.
- Possess excellent people skills in order to influence, motivate, teach and encourage his/her direct staff as well as his/her peers to understand and accept his/her recommendations, especially with borderline issues.
- Excellent delegation skills to oversee and lead the quality department.
- Solid problem-solving skills.
- Excellent technical writing and analytical skills.
- Excellent presentation skills.
- Competence in Microsoft packages specifically word, excel and PowerPoint.
- Ability to work proactively on own initiative
- Results and detail orientated.
- Process improvement and procedure writing expertise.
- Demonstrated project management experience in leading cross-functional teams.
- Flexible, able to adapt quickly to change in a fast-paced environment.
- Willing to travel as required.
Technical Director - Dublin, Ireland - GRIFOLS, S.A.
Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
The Technical Director manages all QA (Quality Assurance), QC (Quality Control), Quality Systems & Compliance and GDP (Good Distribution Practice) functions at the Grifols Worldwide Operations
(GWWO) site. This includes management of RP's (Responsible Persons) and QP's (Qualified Persons).He/She is responsible for the development of all policies, practices, procedures and specifications
applicable to Grifols' products manufactured at GWWO ensuring the quality , safety and efficacy of these products and their adherence to the Grifols Corporate Quality Policies, to the GMPs,
applicable regulations and the corresponding licenses or marketing authorizations.The Technical Director of GWWO must guarantee that Qualified Persons/Responsible Persons can
exercise their functions and responsibilities in accordance with the provisions of the GMPs and applicable legislation.He/She will interface with other members of the senior management team, at their respective sites as well at other Grifols locations, technical departments, customers, suppliers and regulatory agencies in the review of issues and data.
What your responsibilities will be:
What you will bring to the role:
If you're interested in joining our company and you have what it takes, then don't hesitate to apply.
We look forward to receiving your application.
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Location: EMEA : Ireland : Dublin:Grange Castle (Dublin)
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