Quality Assurance Manager (m/w/d) ESO

Job description

Stellenbeschreibung

• Lead External Suppliers Qualification process
• Act 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
• 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
Positionsbezeichnung

Quality Assurance Manager (m/w/d) ESO

Desired profile

Mindestanforderungen

• Bachelor degree or higher in Biochemistry, Chemistry, Microbiology or another related science
• 5 years experience in the pharmaceutical industry/ device industry
• Experience in QA operations, production, QC and/or other relevant operational areas, but must have a min. of 2 years in QA
• Ideally 2 years of management and or project management experience or equivalent
• Thorough knowledge of cGMP requirements
• Solid understanding of regulatory requirements for commercial products
• Proven track record with inspections from health authorities is preffered
• Strong understanding of risk assessment and risk management fundamentals/tools
• Technical understanding of pharmaceutical processes
• Team and consensus builder, with definitive and authoritative decision making ability
• Fluent in English, good skills in German desired

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
Art der Stelle

Vollzeit
Land

Deutschland
Standort

Barleben
Funktionsbereich

Quality
Division

Novartis Technical Operations
Geschäftseinheit

NTO QUALITY
Anstellungsverhältnis

Unbefristet
Unternehmen/Rechtsträger

Salutas Pharma GmbH