Vendor Quality Lead
Contracting – Brabant Wallon
Your responsibilities:
- Be the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) to allow assessment.
- Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, QuickScore) and track the vendor’s performance
- Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain 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.
- When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
- Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
- Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
- Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure 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 work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
- Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
- Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
- Cover 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
- Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
- Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
- Ensure review of relevant RA dossier section related to the assigned vendors
- Have the overview of audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
- Be the QA stakeholder for Vendor Risk management.
- Manage and control quality documents related to the vendors in the Controlled Documents System
- Support on customer audits and Health Authority inspections at the vendors, as needed
- Receipt, coordinate review and authorize product reworks and repackaging.
- Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL’s on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
- As required provide Operational QA support to vendors for process, equipment and facilities qualification and project support
- Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
- Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
- Acts as a coach for VQL’s with less experience.
- Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process
- Act as coach for the direct reports, perform personal development discussions and manage year-end evaluations and objectives setting (if applicable).
- Oversee the VQL activities performed by the direct reports (if applicable).
Your profile:
- Master's Degree in Sciences
- Must be knowledgeable in several areas 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.
- 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.
- Possess good auditing capabilities and skills
- Must have the ability to manage projects/ activities across global geographies within the area of expertise.
- Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
- Root cause and risk management/assessment skills Problem Solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
Our offer:
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 or send me your CV, [email protected]
