Product Quality Lead

hace 2 semanas

Barcelona, España Novartis A tiempo completo

6000 That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.
- The Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics across multiple sites (or platforms, Drug Substance and Drug Product sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation.**Your responsibilities include, but not limited to**:

- Accountable for end-to-end quality stewardship (Drug Substance and Drug Product) of assigned Novartis biologics product(s) from late phase development to discontinuation.
- Accountable for the end-to-end product quality strategy (Drug Substance and Drug Product) across the global network and drive continual improvement through product and process lifecycle management.
- Provide expert quality guidance, technical support and quality leadership for implementation of quality guidelines, regulations, standards, processes, and strategy for assigned product(s) throughout the product and process lifecycle.
- Maintain global Quality oversight, oversee global regulatory filing activities including product registration and variation management, of assigned Novartis biologics product(s).
- Act as global quality lead in product related Quality escalations, recalls and BPDR handling for product specific quality and compliance challenges. Provide clear direction and drive efficient decision making for global Quality issues related to assigned products.
- Involved in major product relevant investigations, in particular multi-sites deviations and recurring deviations, by leading / supporting global investigations / Task Force at the sites.
- Support global site readiness for product pre-approval inspections across the platform / network.
- Maintain global quality oversight on Product Launch, Supply Chain, and Technology Transfers.
- Bridge between clinical, development and technical operation teams and engages at multiple interface(s) be-tween the organizations to functionally lead and drive robust execution of the defined Product related Quality Program.

**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**:

- Education: Bachelor degree or higher, MSc / PhD in Biochemistry, Pharmacy, Chemistry, Microbiology or another related science
- 10 years of experience in an operational GxP area, in Manufacturing/Development or Quality
- Solid knowledge in biology/chemistry, pharmacy and biotechnology, medical devices/combination products
- Thorough knowledge and expertise in cGMP and applicable guidelines
- Sound scientific, technical and regulatory knowledge, ideally in Biotechnology
- Excellent and proven ability to analyze and evaluate cGMP compliance
- Proven ability to influence people and communicate in a process-oriented organization;
- Excellent organizational and management skills.
- Fluent English, written and spoken

**Desirable requirements**:

- Expertise in validation (process and cleaning)
- Knowledge of French or German is highly valued

**You’ll receive**:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.**Why consider Novartis?**

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
- We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.**Imagine what you could do at Novartis**

**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- Spain

**Work Location**
- Barcelona Gran Vía

**Company/Legal Entity**
- Novartis Farmacéutica, S.A.

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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