Site Quality Head (m/f/d)

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

For our site in Krems, we are currently looking for a:

Site Quality Head (m/f/d)

Job intention is the management of the Quality unit consisting of the elements Quality Assurance, Quality Control, Quality Systems and Compliance, Product Surveillance and Quality Improvement with the purpose to ensure Quality oversight and compliance according to the current guidelines at the manufacturing site Krems, enabling in close collaboration with manufacturing unit unconstraint compliant supply of vaccines according to global and local legislations.
This position reports to the Quality Lead Europe and has about 10 direct reports, managing an organization of 45 - 60 people.

EXPECTED RESULTS / FUNCTIONAL ACTIVITIES

Divisional Liason

• Alignment of Manufacturing and Quality strategies, as a member of the Krems Site Leadership Team and represent Quality unit in- and externally.

Planning and Budget

• Translate Manufacturing strategies into proposals for Quality plans and ensure budget management and required reporting.

Operational Management

• Ensure execution and implementation of Quality plans, manage Quality unit related processes, monitor progress, and take corrective actions when necessary.
• Holder of position has disciplinal and functional authority of the Quality Operations unit and a GMP-functional authority of the Manufacturing unit of the site.

Improvements

• Initiate, prioritize, manage or co-ordinate improvement initiatives for Quality processes and take corrective actions when necessary.

Expertise and Advice/Co-ordination

• Ensure initiation, development and implementation of knowledge, standards, procedures, and guidelines within the Krems site.

Compliance

• Ensure compliance of Quality processes with relevant regulations, ensure problem solving and information of relevant parties

Projects

• Determine Quality unit's project portfolio and steer, sponsor and/or participate in projects in Quality and site related projects.

Management Information

• Ensure production of periodical and ad hoc reports and/or analyses regarding quantitative and qualitative Quality developments.

People Management

• Ensure recruitment and retaining of employees, development and execution of training programs and execution of all performance management activities.

Contacts

• Global Management
• Health autoritäres
• Site Operations Management

Functional Core Competencies Quality

Regulatory Standards and Compliance

• Able to proactively respond to new regulations and global/emerging market changes to identify the implications of these regulations on applicable quality standards.
• Uses knowledge of HA and regulatory authority expectations to uphold behavior that maintains our compliance and to ensure product quality standards are met.

Proactive Quality Improvement

• Proactively identifies opportunities to improve quality processes and approaches.

Quality Risk Management

• Uses in-depth knowledge of risk management principles and their application to support product development and process improvement within the pharmaceutical quality system.

Customer and Supplier Management

• Provides input to constituent groups to help develop their quality standards across global markets.

Quality Management System Integration

• Able to identify opportunities to improve the existing quality system including integration of procedures, policies and plans across all components of the system.

Education/knowledge/experience

Education:

• Minimum Master's degree in a relevant field.

Experience:

• Minimum of 10 years of relevant work experience
• Several years of management experience

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 102.800 and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us--and start making your impact today.