QA Field and Strategic Manager

Quality Mentor:

This position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities.
In addition this position is accountable for the Quality related activities associated with SAP master data and Master Packaging Sheet (MPS) validation.

Mission responsibilities:
Provide QA support for all commercial initiatives and commercial activities.
Cover the entire products life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements.
Provide expert QA advice, support and management for technical operational QA and general QA matters.
Be the central point of contact for the organization for investigations/deviations/audit observations.
If needed work with the team to determine the Root cause of issues which may lead to a Technical meeting.
Owner of the QA plans and product resource and capacity overview for activities.
Ensure all relevant documentation are provided to the operator and implemented (Methods, Specs, Master Batch record)
Ensure review of RA dossier related to your operator
Have the Overview of UCB audits and inspections of CMOs and sites related to the Vendors
Be the QA stakeholder Vendors Risk management.
Establish key performance indicators (metrics) for key operational QA activities and services associated with the operators
Provide Operational QA support to other operators when requested
SAP/MPS Quality related accountabilities:
Release of Bill Of Materials (via Engineering Change Orders) related to the above Finished Products
Provide QA support to DMT and other relevant teams in dealing with issues (deviations, complaints) linked to SAP set-up of those Finished products
Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Specific professional/technical expertise and key skills required:

1. Experience
Minimum of 10 years working in the pharmaceutical/biologics industry in a quality management position. Operational GMP experience would be a distinct advantage.
Experience interacting with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection preparedness.
Auditing expertise.

2. Specific skills
Fluency in English
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 possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
Must be skilled and experienced in operating across cultures and in a multi-cultural environment
Travel to France & Germany is required on a regular basis