343705BR
May 10, 2022
Italy

Job Description

The CMO Quality Manager will be responsible for managing quality aspects at third party suppliers for AAA and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Quality Manual and is conducted according to the relevant SOPs.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Acts as Single Point of Contact / SPOC for all quality related activities at the Third Party Supplier, leading also Third Party Suppliers Qualification process.
• Ensure that all aspects of the handling, manufacturing and distribution of drug substance /drug product/ intermediate product/material/GMP consumables are in compliance with the Quality Manual
• Being responsible for driving or initiating Third Party Supplier Quality risk assessments to be carried out for all Third Party Suppliers. Identify gaps with Quality Systems with an evaluation of the associated risks. Define and monitor remediation plans to ensure that issues are suitably addressed
• 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 AAA and the Third Party Supplier, as well as Product details and requirements.
• Request, review and process GMP documentation as defined by the Quality Agreement and SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
• Being responsible for coordinating and ensuring that quality auditing of Third Party Suppliers is carried out according to the Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at Third Party Suppliers where appropriate.
• Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Quality Manual. Ensure investigations are correctly executed.

Diversity & Inclusion / EEO

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:

• Education: Bachelor Degree in Biochemistry, Chemistry, Microbiology or another related science
• Languages: Italian and English proficient
• At least 5 years’ experience in the pharmaceutical industry, with direct experience with pharmaceutical or Biopharmaceutical or Radiopharmaceutical or API products.
• Previous experience in Third Party Supplier oversight
• Thorough knowledge of cGMP requirements and strong understanding of regulatory requirements for commercial products

Work location: Colleretto Giacosa – Ivrea (TO)

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!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Italy
Colleretto Giacosa
Quality
Full Time
Regular
No
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343705BR

CMO Quality Manager

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