Vendor Quality Lead Drug Product

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #16363

Vendor Quality Lead Drug Product

Contracting – Walloon Brabant

#quality #vendor #drugproduct #qa #gmp #operationnalQA #pharma

Our partner is currently looking for a Vendor Quality Lead Drug Product to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?

As a Vendor Quality Lead Drug Product, you will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Japanese Global Vendors located (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for our client’s products. To be successful in your role, here are your tasks:

  • Being 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 and change controls, retrieving and collecting supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) 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 performing periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
  • When applicable, being sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
  • 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 Controlled Documents System.
  • Participating as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
  • Monitor and trend vendor performance including tracking of CAPA events and closure
  • Quality Complaints: Being the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensuring that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed. 
  • If needed, working with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinating vendor quality related investigations
  • Participating on ad-hoc basis to the Product Change Control Committees for activities related to the vendors and review change controls as QA stakeholder.
  • 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 commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
  • Owning 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 audit and HA inspections related to the vendors. Tracking and following-up on Audit observation and CAPA plan implementation at the vendor.
  • Being the QA stakeholder for Vendor Risk management. 
  • Managing and controlling quality documents related to the vendors in the Controlled Documents System
  • Providing support to customer audits and Health Authority inspections at the vendors, as needed
  • Receiving, coordinating, reviewing and authorizing product reworks and repackaging
  • Being the point of contact for post-release vendor quality issues (supply chain, distribution, etc.)

Who are you?

You hold a degree in scientific domain. Ideally, you have 5-10 years of experience in the pharmaceutical industry (QA, QC, production). You are experienced in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness. You have experience in conducting customer / vendor audits and participation in the management of regulatory inspections. You speak fluently English.

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Marie Defruit, [email protected]

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