Team Lead QA Compliance

vor 1 Woche


Rheinfelden, Deutschland Tillotts Pharma Vollzeit

To be located at our HQ in Rheinfelden, we are looking for a

**Rheinfelden**:
**Chemistry / Pharma / Biotechnology**:
**100%**:
**Team Lead QA Compliance **100%**:
**Your key responsibilities**:

- Lead and mentor the QA Compliance team
- Ensure readiness for regulatory inspections and customer audits, coordination and preparation of HA inspections
- Plan and perform internal self-inspections and external GDP audits (e.g. distributors, carriers, Affiliates, etc.)
- Supplier selection and qualification to support Tillotts business
- Primary contact point for Tillotts affiliates as responsible QA / Organize & lead the Global Quality Meeting
- Management of GDP Quality Agreements with partners and affiliates
- Establish, maintain, and support a Quality Risk Management approach and Quality Risk Management tools
- Ensure suitainable management of Tillotts eQMS MasterControl
- Optimize the pharmaceutical quality systems, assessing and improving procedures, systems, and quality tools
- Perform shipment releases (incl. document check, specification check, and artwork check where applicable), ensure on-time releases by the QA Compliance team
- Author, review, and approve QA documents (e.g. Policies, SOPs, Work Instructions)
- Perform GxP, system, and process trainings and support of all Tillotts's departments in GxP topics
- Support the organization with monitoring of compliance quality process and GxP standards
- Keep track of new regulatory guidelines and implement them together with the QA Team at Tillotts / Lead the guideline committee to review the impact of new regulatory guidelines on the organization
- Responsible for the safety and health of the QA Compliance team in the workplace /Responsible for the implementation of the HSE regulations for the QA Compliance team

**Who you are**:

- University degree in Pharmacy, Chemistry, or professional equivalence
- 5-10 years of relevant experience in QA Compliance in the pharmaceutical industry (especially GMP, GDP)
- Proven experience working according to GxP Guidelines
- At least 5 years of leadership experience, line manager
- Ability to work under pressure and prioritize tasks
- Able to lead, influence, communicate and interact with people at all levels across the company as well as external partners
- Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions
- Strong interpersonal and communication skills
- Fluency in English and German (written and spoken)

**What we offer**:

- A great opportunity to work in a diverse environment where you can learn, develop your existing competences, and learn new skills.
- A good working environment where you can directly shape and affect our business. You will be in the front line working with various departments with high visibility to senior management.
- A highly flexible workplace where we respect Work-Life balance and where open communication and great team spirit is highly valued.

**Work-Life Balance**:
**Mobility**:
**Recognition**:
**Social Security Benefits**:
**Professional Development**:
**Social Events**:

- Tillotts Pharma AG
Yolanda Perez
Senior Manager HR Operations
Baslerstrasse 15
4310 Rheinfelden**This is us**:

- Tillotts Pharma AG is a Swiss-based pharmaceutical company with global reach that is part of the Japanese Zeria Group. We are motivated to deliver quality and value to healthcare professionals and dedicated to improving the lives of people with gastrointestinal and infectious diseases.

Tillotts employs over 400 highly motivated and dedicated people. We have over 20 nationalities across our headquarters in Rheinfelden, near Basel, and our affiliates throughout Europe.

We form a diverse and dynamic team where everyone can achieve their full potential and learn from each other. Our collegial culture is characterized by trust and openness, and we are proud of what we do.



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