Description
QA Field and Strategic Manager
Mission Description:
This position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Vendors engaged in GMP activities. This will be achieved through close partnering with QA management for vendor sites, and in collaboration with Technical Operations and other teams.
In addition this position is accountable for the Quality related activities associated with SAP master data and Master Packaging Sheet (MPS) validation as far as it concerns the vendors.
The incumbent takes responsibility for above summarized scope of activities in relation to 2 manufacturing site (France - Germany).
Mission responsibilities:
1. QVM related accountabilities:
- Cover the entire products 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
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the Vendor
- Responsible for ensuring routine LifeCycle Product Management activities are supported
- Participate in the Change Control Committee for activities related to the Vendors
- Participate in the customer complaints committee for activities related to the Vendors
- Ensure all relevant documentation are provided to the Vendor and implemented (Methods, Specs, Master Batch record)
- Be the QA stakeholder Vendors Risk management.
- Work closely with staff in the Corporate QA teams (especially CMC Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for the Vendors are provided in an effective and efficient way.
- Establish key performance indicators (metrics) for key operational QA activities and services associated with the Vendor
2. SAP/MPS Quality related accountabilities:
- Activate Finished Products Codes and associated printed components codes linked to vendors
- Release of Bill Of Materials (via Engineering Change Orders) related to the above Finished Products
- Validate MPS for those Finished products linked to vendors
- Provide QA support to DMT and other relevant teams in dealing with issues (deviations, complaints) linked to SAP set-up of those Finished products
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.
2. Qualification
- Min. bachelor degree
3. 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 be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Key words: QA, Manager, Field, Strategic, Operationnal, SAP, Vendors