the goal of this function, as the primary quality contact, is to ensure global quality practices are integrated in the region to ensure Compliance and safety obligations are met with regard to ucb and local regulations.
this position is responsible for the maintenance of the GXP status of the affiliate in accordance with national and international GMP and legal requirements.
release of products according to the requirements including final evaluation of deviations with regard to their impact on the pharmaceutical quality of drugs.
- deliver best in class service and ensure implementation, maintenance, and upgrading of the local Quality System in order to drive Compliance of all relevant cgxp with local/international regulatory requirements and ucb global standard operating procedures
- lead and coordinate periodic management review of Quality Systems
- ensure efficient information flow and effective communication of all relevant quality matters within the relevant affiliate organization, from the territory to the global quality organization and vice-versa including but not limited to issue escalation and communication of new regulations
- ensure that co-ordinated contact is maintained with the local regulatory authorities and the local partners (suppliers, third parties, licensees, and distributors) and interface with authorities in collaboration with ra as appropriate
- ensure affiliate readiness for all GXP regulatory inspections and management of those inspections.
- ensure that adequate input is provided through the relevant quality plan and Budget Process to make sure adequate quality resources are available.
- ensure that appropriate Quality Management of local partners/vendors/3pls to the external network governance (eng) guidance (Qualification, quality agreements, vendor management, divestment) and manage qa activities associated with global partnerships where agreed
- ensure all quality deliverables are completed in a timely manner in accordance with corporate qms (e.g. follow up and closure on all relevant complaints, deviations and capas, change controls)
- support global projects on Quality Systems as needed.
- maintain list of all local licenses and certificates in collaboration with ra
- minimum of 10 years working in the Pharmaceutical Industry in a Quality Management position. operational GMP experience would be a distinct advantage.
- experience interacting with regulatory bodies and third party organisations with respect to qa systems and regulatory inspection preparedness
- Auditing expertise would be a distinct advantage.
- solid knowledge of relevant legal requirements of the global Pharmaceutical Industry, including the interpretation and practical application of applicable regulations. has good background knowledge of the Pharmaceutical Industry from a business and technical perspective.
- ability to work with high level of autonomy and handle complex/difficult situations. output from actions will most likely impact activities across several departments.
- possess Auditing capabilities and skills.
- must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product and quality related matters.
- management skills + Project Management skills
- strong motivator that can set challenging objectives for self and others and drive for results.
- must possess excellent interpersonal, verbal, and written Communication Skills at all levels, internally and externally, especially at senior management level.
- self-motivated team player, who can encourage and support new ideas and act as a role model for others in driving the departmental/company vision.
- be able to Coach/train/mentor colleagues, as well as deliver Training within area of expertise and assist with the development of top talent
- must be skilled and experienced in operating in a multi-cultural environment
- must possess root cause and Risk Management/assessment skills
フレックスタイム制 （コアタイム無し） 7.5ｈ×月間所定労働日数で清算
Find a Job Find Candidates