Quality Assurance

Vor 4 Tagen

Basel, Schweiz Lonza Vollzeit

Switzerland, Basel**Quality Assurance Manager (Supply Chain Compliance Manager)**

**Location: Basle/Switzerland**

**Fixed Term Contract - End Date December 2025**

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

**Role Purpose**:
Assist the implementation of integrated offering for Lonza Sales AG.

**Key responsibilities**:
Responsible for ensuring compliance with:

- Federal Act on Medicinal Products and Medical Devices (HMG SR 812.21)
- Medicinal Products Licensing Ordinance (AMBV SR 812.212.1)
- Ordinance on Medicinal Products (VAM SR 812.212.21)
- Good Distribution Practice of Medicinal Products for Human Use (2013/C 343(01))
- Falsified Medicines Directive (2011/62/EU)
- Legal requirements and mandatory due diligence by Swiss firms wishing to engage in foreign trade with medicinal products from Switzerland (Swissmedic I-SMI.TI.18)
- Good Manufacturing Practice (Eudralex vol. 4) in line with oversight of licensed activities associated with contract manufacturing activities, as required per Swissmedic
- Oversee shipment validation processes to maintain product quality and safety
- Oversee the qualification of service providers
- Create / implement the temperature monitoring and transportation related incidents SOP.
- Assessment of transportation carrier routes and modes.
- Provide expertise in Regulatory Compliance for the products traded by Lonza Sales AG
- Ensure that products-related GMP activities that are delegated or contracted to other Lonza Sales AG sites or third party contract sites by the RP are controlled through agreements and where appropriate audits.

**Key requirements**:

- In depth knowledge of Good Distribution Practice requirements and regulations, experience in warehouse management is an asset
- 5+ years experience within pharma industry, preferably in a QA or GMP focused role
- GDP certificates or other relevant certifications is a plus
- Understanding of the cGMP regulations, especially GDP
- Strong organizational and problem-solving abilities.
- Ability to work autonomously with and to develop procedures if required
- Ability to oversee project execution to identify non-compliance from quality standards
- Excellent verbal, written and interpersonal communications skills in English (German is a plus)
- Ability to work in partnerships as an active member of a team and or/cross functional working groups
- Requires independent decision making regarding quality and compliance.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

LI-SG1
- Reference: R60030
- Apply

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