Vendor Quality Lead
Brabant Wallon – contracting
Your responsibilities?
This position will provide leadership and in-depth QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for the company Products.
- Ensure all Quality agreements are in place and take ownership of agreements for the vendor(s). Maintain Quality Agreement with the vendor(s) up to date and perform periodic reviews and update of the agreement in close collaboration with the appropriate internal stakeholders (mainly the Vendor Team and External Vendor Team) and the vendor(s).
- Ensure all relevant documentation are provided to the vendors and implemented
- Be the central QA point of contact for the Quality management of: Investigations / deviations / out-of-specifications associated with the assigned vendor(s); Change Controls associated with the assigned vendor(s); Perform the QA review of the above records, retrieve and collect supportive information from involved to allow assessment. Perform the QA approval of the above records. Ensure that reviews are documented and made available in the internal Controlled Documents System.
- Drive resolution for complex quality issues related to the vendor(s) 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.
- When needed work with the Vendor team and the CMC Quality Lead(s) to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor(s) quality related investigations.
- Participate on ad-hoc basis to the company Product or Global Change Control Committees for activities related to the vendor(s).
- Ensure the key performance indicators (metrics) for key operational QA activities and services associated with the vendor(s) are managed with the support of the Vendor Quality support Team. Ensure the vendor performances are tracked in the defined tracking tools (Vendor QA KPI). Manage the periodic updates of the Vendor Quality Risk Score (QRS).
- If applicable, put in place and follow-up on the reinforced Quality Plan with the vendor(s).
- Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested timelines. Ensure that this review is documented and made available in the company Controlled Documents System.
- Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings.
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendor(s).
- Be the QA stakeholder for the Operational Review Meeting (OMR) preparation and discussion, for the company Vendor Risk management and for the setup of the Vendor Team objectives.
- When applicable, be the contact person for the follow-up with vendor(s) on Quality Complaints (Market complaints). Ensure the manufacturing investigation part is properly managed by the Vendor(s) from the initial notification until the reception of the investigation report.
- Support the Corporate audit preparation and attend, when needed, the Corporate Audit as observer, for the assigned vendor(s). Manage the follow-up on Audit observation and CAPA plan implementation at the vendor(s)
- Have the overview of HA inspections related to the vendor(s). Track and follow-up on Audit observation and CAPA plan implementation at the vendor(s), as per QAA.
- Coordinate the requests for Health Authorities in the context of a submission (Response to Question process) for the vendor team in collaboration with the CMC Quality Lead.
- Ensure the Audit / HA Inspections and CTR trackers are up to date for the need of monthly KPIs completion.
- Support on customer audits and Health Authority inspections at the vendor(s), when needed.
- When applicable, 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 vendor(s).
- Develop and own the QA plans and product resource and capacity overview for activities associated with the assigned vendor(s).
- When needed, ensure the relevant RA dossier section is reviewed and communicated to the assigned vendor(s).
- Manage and control quality documents related to the vendor(s) in the Controlled Documents System.
- When applicable, coordinate review and authorize product reprocessing and repackaging.
- Work in accordance with HSE and Corporate policy requirements and drive personal trainings and development activities to meet the needs of the business and professional career development.
- As required provide Operational QA support to other vendor(s).
- Act as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process.
- Act as a coach for the internal direct reports, perform personal development discussions and manage year-end evaluations and objectives setting.
Your profile?
- You have a Scientific or Engineering Degree (or equivalent acquired through professional experience)
- Minimum 5 years experiences in Quality Assurance in a pharmaceutical environment
- 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, supply 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 be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
- Must possess excellent interpersonal, verbal and written communication skills at all levels internally and externally especially at senior management levels.
- 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.
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.
Do you have any questions? You can contact Anaïs Malikian, [email protected]
