Vendor Quality Lead Drug Product
This position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for our client’s Products.
The 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, 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, Side impact) 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.
- 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) escalation meeting. Coordinate vendor quality related investigations.
- 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.
The Skills and Knowledge Requirements
- 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 capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
- Root cause and risk management/assessment skills
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Please reach out to Aylin, [email protected]
