Head QA Development (m/f) Respiratory Products – Quality Assurance

Job description

Stellenbeschreibung

For over a hundred years, doctors, pharmacists and patients all over the world have placed their trust in the quality medicines from SANDOZ. Following this tradition, the company’s 20,000 employees develop, produce and market high-quality, affordable medicines. SANDOZ is active in over 110 countries and part of NOVARTIS.
Choosing SANDOZ is always “a healthy decision”. Through our work and our medicines, we have committed ourselves to improving the quality of life of people all over the world. Sandoz has invested 47 million Euro into a new development and manufacturing facility for inhalation products. Let’s explore the future together!

For our Sandoz Global Competency Center for Inhalation - AEROPHARM GmbH, we are currently looking for an experienced

Head QA Development (m/f) Respiratory Products – Quality Assurance

in Rudolstadt, Thuringia

As Head QA Development, you will part of the Sandoz Development Center, responsible for leading the QA Development team of four at our Aeropharm facility in Rudolstadt which produces high-class inhalation products.
Your main task is to ensure all processes within your department as well as all projects are up to the required GMP standards and projects are completed in a timely and compliant manner.
You will be responsible for managing strategically as well as operationally all transfers from the development stage to the technical operation subject to all quality assurance aspects and compliant with the GMP standards. For enquiries regarding QA, you will be the point of contact for external authorities as well as preparing, monitoring and post-processing external audits and internal audits from the Corporate QA department.
At our Aeropharm site, you are responsible for monitoring Key Quality Indicators, initiating and implementing quality improvement programs and comprise regular reports for the Global QA organization.
As a quality expert, you obtain knowledge regarding quality relevant international standing orders, guidelines and regulatory trends and, when necessary, collaborate to implement new global quality tools and processes.
Furthermore, you review documents such as validation plans, quality reports, transfer plans.
You collaborate closely with a diverse number of partners and stakeholders across the organization such as the QA Technical Operation as well as your peers of the SDC leadership team and other development QA heads across the global organization. You report directly to the Global Head QA Product Development.
Positionsbezeichnung

Head QA Development (m/f) Respiratory Products – Quality Assurance

Desired profile

Mindestanforderungen

Your profile

• Academic degree in Science (pharmacy, chemistry, biology or similar)
• Proven professional experience in quality control or assurance or quality management in the pharmaceutical industry
• Strong knowledge of GMP and regulatory guidelines in the pharmaceutical industry
• Min. 3 yrs leadership experience
• Ability to prioritize, hands-on personality as well as strategic abilities, good judgement, problem-solving abilities, ability to win people, solution-oriented
• Fluent in English

We are looking forward to you taking part in one of Sandoz' biggest growth initiatives and supporting AEROPHARM’s expansion. We are looking forward to getting in touch with you as soon as possible. Please apply via our online tool.

Sandoz is an equal opportunity employer - a Novartis company

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
Art der Stelle

Vollzeit
Land

Deutschland
Standort

Rudolstadt
Funktionsbereich

Quality
Division

SANDOZ
Geschäftseinheit

Product Dev SZ
Anstellungsverhältnis

Unbefristet
Unternehmen/Rechtsträger

Aeropharm GmbH