Quality Assurance & Control
Our client is a European, research oriented Pharmaceutical / BioTech company, global player, within Top 10 of the industry.
The Quality Assurance Organization is in full expansion, this job profile is newly established for managing external suppliers under quality aspects. The place of work is in the inner city of Magdeburg with direct contacts to the headquarters in Basel. Travel activities, mostly in Europe, will have some 20% of total time, there are no activities in operative production or QA. This offer serves as entrance to company extremely successful, if desired other functions will follow.
We are looking for our client for a
Senior External Supply Quality Assurance Manager (m/f)
In this position you manage quality aspects at external suppliers for Pharmaceuticals / Devices with complex and high risk product portfolio and you ensure that the operational business is in compliance with GMP, the Quality Assurance Agreement and regulatory requirements.
Your key responsibilities are as follows:
- Lead External Suppliers Qualification process
- Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier
- Ensure that all aspects of the handling, manufacturing and distribution of products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
- Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. If gaps are identified, remediation plans are to be defined to ensure that issues are suitably addressed.
- Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
- Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements. Signs QA agreements if assigned by QA Lead.
- Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Makes recommendations for amendments to the agreement based on identified needs and issues.
- Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual. Ensures action plans are in place and follow up on agreed on CAPAs is performed. Supports site readiness for regulatory inspections at External suppliers where appropriate.
- Manages all critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed.
- Ensure that the QA Lead and the Supplier Relationship Manager is kept informed of all critical and major issues which may have an adverse affect on the quality of the product at an External Supplier
To fill this position successfully you have a degree in Biochemistry, Chemistry, Microbiology or another related science and 5 or more years experience in the pharmaceutical industry / device industry as well as experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 2 years in QA, 2 years of management and or project management experience or equivalent.
Do you have thorough knowledge of cGMP requirements and solid understanding of regulatory requirements?
For this position we are looking for a team and consensus builder, with definitive and authoritative decision making ability.
If you feel attracted by this position we kindly ask you to apply in full confidentiality in English, with resumee and list of key competences.
PP PHARMA PLANING
International Executive Search & Specialist Recruitment Healthcare
Dr. Bergauer + Partner GmbH
Mrs. Brigit Strecker-Gerdes, Senior Partner Consulting
Bismarckallee 2a D-79098 Freiburg im Breisgau
Telefon: +49 761 2 9615-0 oder Direktwahl: +49 761 2 96 15-16
Your application will be treated with strict confidentiality.