**AAA Statement**
**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 Compliance Officer Coordinator supports GxP compliance of AAA commercial products applicable for the site, in accordance with internal procedures and processes as well as Health Authorities regulations.
- In collaboration with the site Quality team, the person will contribute to the appropriate oversight, assessment and mitigation of risk to quality practices, processes and systems to ensure that all aspects are in compliance.
**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Ensure the compliance of the Quality System to the GMP regulation and to the corporate guidelines.
- Coordinate the activities of the QA Specialists.
- Support the annual audit of the manufacturing sites to ensure that the National and Corporate Quality System guidelines are applied at local level and tracking/closure of associated CAPAs.
- Collaborate to the redaction and revision of the Quality Agreements with the Contract Givers and/or the Contract Acceptors.
- Support the qualification activities of AAA suppliers managed at site level (including audits to the suppliers).
- Support escalation management and all commercial product field actions with FDA - Recalls, Market Withdrawals, Quality Assessments and the preparation and submission of Field Alert Reports (FARs) and Drug Shortages
- Support the implementation of training program on site, to ensure all personnel are appropriately trained and proficient in the tasks to execute.
- Support the preparation of the annual site Quality Plan, and supervise the closure of associated actions
**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**:
- Bachelor's Degree or higher in Pharmacy, Biochemistry, Chemistry, Biology, Engineering or other related life science degree.
- Fluent in English.
- +5 years' experience in the pharmaceutical industry with direct experience with Compliance and Quality Systems.
- Experience in drug development, clinical, manufacturing, outsourcing and/or other relevant operational areas which must include at a minimum 5 years in QA.
- People management skills.
Work location: Colleretto Giacosa (Ivrea)**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 groundbreaking 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!
**Imagine what you could do at Novartis!
**
**Division**
- Oncology
**Business Unit**
- ADVANCED ACCELERATOR APPLICATIONS
**Country**
- Italy
**Work Location**
- Colleretto Giacosa
**Company/Legal Entity**
- AAA Italy Srl.
**Functional Area**
- Quality
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No