Quality Assurance Manager, Czech Republic and Slovakia (part-time)

Náplň práce, pravomoci a zodpovědnosti

Our challenge: Your impact!

We aspire to be the patient-preferred global biopharmaceutical leader, transforming the lives of people with severe diseases, and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.

At the earliest date possible we search in the Czech Republic to further strengthen our Quality Assurance function for a

Quality Assurance Manager, Czech Republic and Slovakia (part-time)

The goal of this function is to ensure global quality practices are integrated in the affiliates (the Czech Republic and Slovakia) to ensure compliance and safety obligations within UCB and local regulations. Acts as the Primary QA contact person for the affiliates.

Job responsibilities:
-Lead the local QA organization to deliver best in class service and ensure implementation, maintenance and upgrading of the local Quality System.
-Assure that gaps identified through Key Quality Indicators are addressed appropriately in order to mitigate risk and escalate critical trends to the Local Leadership Team.
-Ensure the affiliates readiness for all GxP regulatory inspections and the management of those inspections.
-Ensure self-inspection plan is in place and adhered to, in collaboration with the Responsible Person for GDP.
-Ensure that any deficiencies identified through audits or other means are addressed timely through the implementation of appropriate corrective and preventive actions.
-Ensure that a local GxP training program is established and trainings are timely performed.
-Manage QA activities associated with Global partnerships.
-Ensure all Quality deliverables are completed in a timely manner in accordance with Global SOPs (e.g. follow up and closure on all relevant complaints, deviations and CAPAs, change controls).
-Lead (if necessary) local recalls following the global recall process.
-Attend leadership management meeting at the affiliate.
-Ensure that appropriate, written procedures are in place to handle critical areas such as quality complaints, product recalls, third party warehouse management, trainings, etc.
-Ensure that all local newly hired staff (permanent and contractor) has the appropriate qualification and training.
-Provide professional input to define and manage risks in the affiliates. Ensure that Affiliate Risk Management Database is updated according to the company request. -Actively participate in risk management planning.

Minimální požadované vzdělání: Secondary with school-leaving examination
Pozici vyhovuje i uchazeč se vzděláním: Follow-up/Higher Professional Education, University education (Master's degree), University education (Bachelor's degree)

Osobnostní předpoklady a dovednosti
Requirements:
-Minimum 3 years of experience in a pharmaceutical industry in a quality management position. -Operational GMP experience would be a distinct advantage.
-Experience in interacting with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection preparedness.
-Solid knowledge of relevant legal requirements for the global pharmaceutical industry, including the interpretation and practical application of the regulations. 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.
-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.
-Strong motivator, setting 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 levels.
-Be able to coach/train/mentor colleagues and deliver trainings within the area of expertise and assist with the development of top talent.
-Must be skilled and experienced in operating across cultures and in a multi-cultural environment.
-Must have ability to identify risks and propose corrective actions within the areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way.

Práce v oboru: Zdravotnictví, farmacie, sociální péče, Management, Právo a legislativa

Lokality: Praha