vendor quality lead drug product

As an Vendor Quality Lead Drug Product your mission will be:

• 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, ILA, ALO, 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, SpiderImpact) 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.

• Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. Ensure that this review is documented and made available in the company’s 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 company’s 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) escalation meeting. Coordinate vendor quality related investigations.

• Participate on ad-hoc basis to the company’s 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 Global QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way.

• Cover 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.

• 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 the company’s audits and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.

Requirements for this mission of A&L Evidence Generation Learning Lead are:

• Master’s Degree.

• 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 be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.

• 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.

• Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.

• Generate commitment from within teams, 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 an 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.

Consultancy project (01/03/2024 to 31/12/2024)

For this position of Vendor Quality Lead Drug Product, we offer an attractive salary with extra-legal advantages:

• Group insurance

• Hospitalisation insurance

• Meal vouchers of 7 euros gross per working day

• Reimbursement km or company car

• Monthly allowance (80 euros net per month)

• A 13th month

• Training

• Etc.

A rate as a freelancer is also possible.