Quality Vendor Manager

Quality Vendor Manager

Scope of work

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.

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

Quality Vendor Management (QAVM) related accountabilities:

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 (internal Vendor Team, GQL, CAS, Business) to allow assessment.

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, are reviewed within the requested time period.

Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors

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

Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendor

Have the overview of internal 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

Provide Operational QA support to other vendors

Specific professional/technical expertise and key skills required:

Minimum of 6-10 years working in the pharmaceutical/biologics industry in a quality management position. Operational GMP experience would be a distinct advantage.

Experience in interaction with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection preparedness.

Auditing expertise.

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.

Possess good auditing capabilities and skills.

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 area of expertise and assist with the development of top talent.
Root cause and risk management/assessment skills
Must have the ability to independently analyse data and information to draw conclusions and make effective decisions.
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
Must be able to develop innovative solutions through judgment and reasoning leveraged from extensive quality experience.