Quality Country Lead
vor 2 Monaten
**AAA Statement**
- Over 1000 associates at 31 sites in 12 countries currently make up Advanced Accelerator Applications. AAA is also an expanding business where we have the unique advantage to leverage the size and scale of Novartis, while working in a culture that is unbossed, curious and inspired - all to create impact for patients**Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.**
**AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).**
The role can be filled in Bonn OR Munich
**Your responsibilities**:
Your responsibilities include, but not limited to:
- Provide the strategic and technical leadership for German sites;
- Ensure the compliance of the Country Quality System to the GMP regulation and to the corporate guidelines;
- Perform the annual audit of the manufacturing sites to ensure that the National and Corporate Quality System guidelines are applied at local level;
- Evaluate the manufacturing sites quality performances defining and monitoring the Key Quality Indicators at National level;
- Upon request of the Corporate Quality Department, collaborate to the redaction and revision of the Quality Agreements with the Contract Givers and/or the Contract Acceptors;
- Actively collaborate during inspections of the health authorities and external bodies (e.g. clients or external certification bodies);
- Manage at Country level the follow up of the health authorities and external bodies (e.g. clients or external certification bodies);
- Coordinate and guarantee the qualification activities of AAA suppliers managed at national level (including audits to the suppliers);
- Perform, at the request of the Quality Corporate department, audits to suppliers managed at the corporate level;
- Management of customer complaints in strict collaboration with the Corporate Quality department;
- Guarantee, in strict collaboration with RA department, that all the variations made to the Marketing Authorization of AAA-MI products are implemented at National level;
- Responsible to ensure appropriate escalation of Quality/cGMP issues and deficiencies to the Head of AAA-MI QA and other Heads of the network if relevant;
- Conducts Quality Assessments with AAA national sites, ensures timely & cGMP-compliant decisions, documentation & follow-up including Health Authority Notifications (e.g. Rapid Alert, market recalls);
- Evaluate performance reports of site QA, initiate corrective actions where necessary, and perform follow-up on resulting measures;
- Report progress in the respective QA-management meetings;
- Provide inputs for the selection, training, people development and performance evaluation, development planning in recruiting process of Quality teams in the sites;
- Ensure QA coverage during launches
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
**What you’ll bring to the role**:
- Scientific Degree
- Mandatory German and good knowledge of English required
- At least 5 years of experience as Manager in a pharmaceutical Quality Department
- Excellent organizational (time management, risk management) and communication skills
- Knowledge of quality system (GMP and ISO)
- Knowledge of regulatory requirements
- Leadership skills
**Why Advanced Accelerator Applications (AAA)?**:
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications(AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer.**How will we continue to be on the cutting edge of medicine?**:
We believe new ground breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Novartis
**Division**
- Oncology
**Business Unit**
- ADVANCED ACCELERATOR APPLICATIONS
**Country**
- Germany
**Work Location
-
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