Vendor Quality Lead EMEA

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Date: May 2, 2019

Location: Braine L'alleud, Walloon Brabant, BE

Vendor Quality Lead EMEA

Global Quality Assurance

Location: Braine l`Alleud

 

Help us transform patients’ lives.

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

To strengthen our External Manufacturing QA team, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of: Vendor Quality Lead EMEA.

 

Do you have the spirit of an entrepreneur that is curious? For UCB, you are an ‘entreprecurious’ person. This specific blend of talent means you are apt at applying ambition to an inquisitive nature for the good of patients.

As a UCB 'entreprecurious' person and Vendor Quality Lead EMEA you like to work in an environment where you can:

  • Provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors engaged in GMP manufacturing activities for UCB Products.
  • Be part of a global QA team at the department heandquarter

 

As a UCB 'entreprecurious' person and Vendor Quality Lead EMEA you will contribute by:

  • Beeing the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Performing the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders to allow assessment.
  • Managing the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance.
  • Ensuring all quality agreements are in place and take ownership of agreements for the vendors. Maintaining Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
  • Ensuring the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensuring that this review is documented and made available in the UCB Controlled Documents System.
  • Participating as QA representative to the recurrent vendor meetings, presenting issues and resolutions, and driving vendor quality performance through these meetings.
  • Beeing the contact person for Quality Complaints. When applicable, ensure that initial receipt, logging of quality complaints into the UCB Complaint System and provision of responses to the complainant are professionally coordinated and managed.
  • Providing expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors.
  • Working closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way.
  • Covering the entire product life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
  • Ownering of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
  • Ensuring all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record).
  • Ensuring review of relevant RA dossier section related to the assigned vendors.
  • Having the overview of UCB audit and HA inspections related to the vendors. Tracking and follow-up on Audit observation and CAPA plan implementation at the vendor.
  • Beeing the QA stakeholder for Vendor Risk management.
  • Managing and controling quality documents related to the vendors in the UCB Controlled Documents System.
  • Providing support to customer audits and Health Authority inspections at the vendors, as needed.
  • Receiving, coordinating review and authorizing product reworks and repackaging.
  • Beeing the point of contact for post-release vendor quality issues (supply chain, distribution, etc.).
  • Working in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
  • Deputising for the Head of EU/APAC external manufacturers when requested.

 

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

  • Minimum of 5 year experienc in the pharmaceutical/biopharma industry in an operational quality position and with additional operational experience from other roles in pharmaceutical GMP manufacturing.
  • Experience in interaction with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection preparedness.
  • Auditing expertise would be a distinct advantage.
  • Good knowledge and application of cGMP regulations concerning API and drug product and combination product.
  • Strong personality with standing and self-consciousness who can easily interact, present, influence and negotiate with senior internal and external personnel on many aspects of project and product related matters.
  • Must be professionally fluent to communicate and debate in English language. French language skills is considered as an enabler in communication with certain vendors / vendor teams.
  • Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
  • Must have the ability to manage projects/ activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.

 

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.


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