Site Quality Head

220 that’s the number associates working in our Quality department. As a QA head, you will run and direct all Quality Assurance and Quality Control activities for the 4 plants (solutions, visco-elastics, ointments and biologicals) as well as all the distribution activities where the Puurs plant is involved.
- Your responsibilities:

- Your responsibilities include, but are not limited to:
- Develop and implement procedures and methods to ensure that the QA department and the Manufacturing unit are compliant with GMP, GDP, Corporate Standards and any applicable Regulatory Standards.
- Staff, train, and develop the department
- Co-ordinate with other members of the management's operating team in the day-to-day conduct of the site's business.
- Develop and implement quality-engineering methods as suitable to improve quality, demonstrate ongoing control and cost efficiency.
- Ensure approval and monitoring of all Belgium suppliers, vendors and contract manufacturers.
- Maintain, along with your team the plant in a validated state.
- Participate in, respond to all Health Authority, internal and external audits, and be the site responsible for this matter. Be the GMP/QS spokesperson during external audits.
- Prepare, present and manage the budget for operational expenses, headcount and capital investments

Responsible Person responsibilities:
- Ensuring that a quality management system is implemented and maintained.
- Focusing on the management of authorised activities and the accuracy and quality of records.
- Ensuring that initial and continuous training programmes are implemented and maintained.
- Coordinating and promptly performing any recall operations for medicinal products.
- Ensuring that relevant customer complaints are dealt with effectively.
- Approving any subcontracted activities which may impact on GDP.
- Ensuring that self-inspections are performed at appropriate regular intervals
- Ensuring that any additional requirements imposed on certain products by national law are adhered to.

**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:
- Master/university education: preferably as (industrial) Pharmacist
- Pharmaceutical industry experience
- At least 10 years relevant working experience (of which the last years in a leading role) in the field of Quality and Compliancy
- Experience in GDP training
- Knowledge of Quality systems, methods, procedures and tools, continuous improvement methodologies and related processes;
- Project and process management skills
- Good communication skills and team player;
- Excellent analytical skills;
- Proficient in English and Dutch

You’ll receive:

- We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules,...). Your office will be based in Puurs. Locally, we offer benefits to ensure our associate's mental and physical well-being. There is a fitness available for our associates to use and we offer a bike-leasing program. We have a mental coach on site as well.
- Why consider Novartis?
- 769 million. That’s how many lives our products touch. 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
- .
- #li-nov**Division**
- Novartis Technical Operations**Business Unit**
- NTO QUALITY**Country**
- Belgium**Work Location**
- Puurs**Company/Legal Entity**
- ALCON BEL**Functional Area**
- Quality**Job Type**
- Full Time**Employment Type**
- Regular**Shift Work**
- No**Early Talent**
- No