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Let's push the boundaries together and make the most of your talents!

Quality Lead Italy

Location: 

Milan, Lombardy, Italy

Job Function:  Quality Assurance
Job ID:  67371

Help us transform patients' lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases.  Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in this pioneering adventure? 

To strengthen our Regional Quality team, based in our affiliate in Milan, Italy, we are looking for a talented individual to fill the position of: Quality Lead Italy.

 

As a Quality Lead Italy you like to work in an environment where you can:

  • Be the primary QA contact for the Italian affiliate and lead of the Local Quality organization. The primary goal of this function is to ensure implementation of UCB Global Quality practices in the area and to ensure compliance with cGxP and local Regulations.
  • Be responsible to maintain and continuously improve the GxP system of the above-mentioned Affiliate, assist in the identification and mitigation of issues and risks, highlight improvement opportunities and facilitates the development of solutions.
  • Ensure all QA deliverables are achieved in a compliant timely manner.
  • Work with the Affiliates management and Regional/Corporate organization to facilitate the proper support for the Local Quality organization.
  • Ensure that all the goods distributed in the Italian territory are in compliance with GMP/GDP and local regulations.

 

As a UCB 'scieninspiring' person and Quality Lead Italy you will contribute by:

  • Facilitating, implementing and maintaining an effective and compliant Quality System in line with the Regional Quality strategy and according to UCB policies, corporate quality standards, global SOPs, cGxP and applicable local regulatory requirements
  • Supporting Regional Quality in defining the appropriate organization of the area, according to UCB strategic plans, with enough competent resources to carry out quality responsibilities
  • Ensure the establishment of a business continuity plan for GxP activities
  • Ensure Country readiness for all cGxP internal, external and regulatory inspections, ensuring systems are in place for managing them and addressing any deficiencies identified through audits or other means by providing guidance for identification and timely implementation of appropriate corrective and preventive actions
  • Partnering with the local area management and Regional Quality Management to establish, optimize, develop and elevate local Quality skills, capabilities and capacities
  • Oversight of the local quality organization by quality governance and quality planning in the countries through the establishment and implementation of a Quality Plan and a Quality System Manual, identifying the appropriate Key Quality Indicators, and applying a Quality Risk Management approach – as appropriate
  • Ensuring the execution, and having the oversight, of the periodic Management Review of GxP Quality Systems and consistently update local area management and Regional Quality management regarding the suitability and effectiveness of the Quality System
  • Ensuring efficient information flow and effective communication of all relevant quality matters within the relevant Affiliate organization, from the Territory to the Global QA organization and vice-versa including but not limited to issue escalation and communication of new regulations
  • Providing quality oversight to Local GxP relevant Vendors particularly such as Contract Manufacturing Organization and Warehouse/Distribution Service Providers in compliance with UCB Quality Standards and ENG guidance (qualification, quality agreements, vendor management, divestment)
  • Ensure that within the area a Local GxP training program is established and training timely performed, documented and its effectiveness checked with the scope of availability of competent Quality personnel
  • Ensure that adequate input is provided through the relevant quality plan and budget process to make sure adequate quality resources are available
  • Evaluation of major / critical deviations with regard to their impact on the pharmaceutical quality of drugs distributed in the Italian territory
  • Ensuring compliance to GDP and ensuring shipping conditions followed, driving a QA decision on the disposition of the product in case of deviations (including temperature excursions)
  • Leading if necessary Local recalls following the Global / Local recall process
  • Ensuring 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)
  • Ensuring periodic Product Quality Review for each product (or APQR) are reviewed and assessed in accordance with the MA holder’s responsibility
  • Ensuring all relevant documents are maintained in the appropriate UCB tool or an appropriate archiving system is in place
  • Ensuring appropriate qualification of site computerized systems, if applicable
  • Attending leadership management meeting at the Affiliate, as needed
  • Ensuring inter-site quality agreement with Global QA and associate appendices are complete and up to date
  • Ensuring appropriate systems in place at the Affiliate to ensure product traceability of all products

 

Interested? For this position you’ll need the following education, experience and skills:

 

  • 5 years ‘experience working in the pharmaceutical industry in a Quality Management position, having operational GMP experience
  • Experience interacting with Regulatory Bodies and Third-Party Organizations with respect to Quality Systems and Regulatory inspection preparedness
  • Solid knowledge of relevant legal requirements of the 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 good 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, 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 levels.
  • Self-motivated team player, 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 and deliver training within 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
  • Root cause and risk management/assessment skills
  • Must have the ability to independently analyze data and information to draw conclusions and make effective decisions
  • Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way
  • Must be able to coach staff and colleagues through effective problem solving to ensure the best resolution is obtained
  • Must be able to develop innovative solutions through judgment and reasoning leveraged from extensive quality experience
  • Italian: mother tongue; English. fluent

 

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

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