Vendor Quality Lead Job Smyrna area,Georgia USA,Quality Assurance

Primary Purpose / Regulatory Responsibilities

This position will provide leadership and in-depth QA expertise in driving strategic and operational Quality Assurance activities associated with complex Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for company Products.

This will be achieved through close partnering with QA management within company and at interfaces with Product CMC Quality Leads, Vendor Quality Leads for other vendor sites, and in collaboration with company Technical Operations and other company teams (Vendor Team, Extended Vendor Team).

The incumbent takes responsibility for above summarized scope of activities in relation to the assigned Manufacturing sites.

Major 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 and investigations, retrieve and collect supportive information from involved stakeholders (company Vendor Team, CMC Quality Leads, 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 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 vendors.

When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the company Stability Program.

Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the established lead times. Ensure that this review is documented and made available in the company EDMS.

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 Complaint System and provision of responses to the complainant are professionally coordinated and managed.

If needed work with the Vendor team and CMC 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 company Product/Global Change Control Committees for activities related to the vendors.

Provide in-depth expert QA advice, support and management for technical operational QA and general QA strategic 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 commercialisation 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 company 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 company EDMS.

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. Be the point of contact for…