QA Manager

**QA Manager (d/f/m), Schaftenau, Tyrol, Austria**

25 This is the number of Novartis production sites that our Austrian External Supplier Organization (ESO) Team supports all over the globe. Being part of the ESO team you will be working in a very international team with a lot of global interaction and attractive tasks.

As a QA Manager, you will ensure all aspects of manufacturing, testing, release and distribution for bio-logics and/or sterile pharmaceutical products at external supplier sites comply with interna-tional standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Novartis Group Quality Manual, and the applicable Quality Agreements.

**Your Responsibilities**:
Your responsibilities include, but are not limited to:

- Act as single point of contact for all quality related activities at the external supplier. Provide the quality presence and input to technical meetings with the external suppliers and establish good working relationships.
- Lead the external supplier qualification process, including setup and maintenance of related core documents (e.g. quality assurance agreement, supplier quality risk assessment).
- Manage all quality aspects of the relationship in accordance with the effective Quality Agreement, the Novartis Quality Manual, relevant cGMP regulatory requirements and local SOPs. Including but not limited to the management of investigations (complaints, deviations, out of specification results, quality events), change controls, and regular quality reviews (e.g. annual product review)
- Oversee the technical release of batches manufactured at the CMO. Including but not limited to batch record review, incident review, and change review.
- Assess quality trends and drive continuous improvement including stability reports and annual product quality reviews. Escalate any incident per Novartis escalation policy, and initiate any market action that is required
- Ensure QA Oversight during commercial product transfers. Assesses validation readiness. Ensures knowledge transfer for stable commercial manufacturing operations. Supports the establishment of continuous process verification programs.

**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 or higher in Biochemistry, Chemistry, Microbiology or other related science
- Fluent in English -spoken and written
- Minimum 5 years of experience in in the pharmaceutical industry.
- Minimum 3 years of experience in the manufacturing of sterile pharmaceuticals. Good understanding of aseptic/sterile pharmaceutical processes.
- Minimum 3 years of experience in operational quality assurance. Good knowledge of cGMP requirements for major regulated markets (EU, US).
- Proven track record with FDA, EMEA and other Health Authorities
**Desirable requirements**:

- Team player with a structural and pragmatic working style
- A high degree of flexibility, the ability to work under pressure and good communication skills strengthen your profile
**Why Novartis?**
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and 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**

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group.

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 52,204.04/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

We are open for part-time and job sharing models and support flexible and remote working where possible.

**Commitment to Diversity & Inclusion**:Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are