Head of Site Quality Assurance
vor 4 Wochen
Our Manufacturing & Supply Division is committed to being the most reliable provider of biopharmaceuticals globally. Our facilities, along with our external partners, suppliers, and contractors, form a dependable international manufacturing network dedicated to delivering high-quality products to customers and patients consistently and punctually.
For our site in Krems, we are currently seeking a:
Site Quality Head (m/f/d)
Role Overview: The primary objective of this position is to oversee the Quality unit, which encompasses Quality Assurance, Quality Control, Quality Systems, Compliance, Product Surveillance, and Quality Improvement. This role is essential to ensure quality oversight and adherence to current regulations at the Krems manufacturing site, facilitating seamless collaboration with the manufacturing unit to ensure compliant vaccine supply in accordance with global and local regulations.
This position reports to the Quality Lead Europe and includes approximately 10 direct reports, managing a team of 45 to 60 individuals.
Key Responsibilities:
Strategic Alignment:
Collaborate with the Krems Site Leadership Team to align Manufacturing and Quality strategies, representing the Quality unit both internally and externally.Planning and Budget Management:
Convert Manufacturing strategies into actionable Quality plans while ensuring effective budget management and necessary reporting.Operational Oversight:
Ensure the execution and implementation of Quality plans, manage processes related to the Quality unit, monitor progress, and initiate corrective actions as needed. Possess disciplinary and functional authority over the Quality Operations unit and GMP-functional authority over the Manufacturing unit at the site.Quality Improvement Initiatives:
Initiate, prioritize, and manage improvement initiatives for Quality processes, taking corrective actions when necessary.Expertise and Coordination:
Ensure the initiation, development, and implementation of knowledge, standards, procedures, and guidelines within the Krems site.Regulatory Compliance:
Guarantee compliance of Quality processes with relevant regulations, ensuring effective problem-solving and communication with relevant parties.Project Management:
Define the Quality unit's project portfolio and lead, sponsor, or participate in Quality and site-related projects.Management Reporting:
Ensure the preparation of periodic and ad hoc reports and analyses regarding quantitative and qualitative Quality developments.People Management:
Oversee recruitment and retention of employees, develop and implement training programs, and manage all performance-related activities.Key Contacts:
Global Management Health Authorities Site Operations ManagementQualifications:
Core Competencies in Quality:
Regulatory Standards and Compliance:
Proactively respond to new regulations and global market changes, identifying their implications on applicable quality standards. Utilize knowledge of health authority expectations to maintain compliance and ensure product quality standards are upheld.Proactive Quality Improvement:
Identify opportunities for enhancing quality processes and methodologies.Quality Risk Management:
Apply in-depth knowledge of risk management principles to support product development and process enhancement within the pharmaceutical quality system.Customer and Supplier Management:
Provide insights to constituent groups to help establish their quality standards across global markets.Quality Management System Integration:
Identify opportunities to enhance the existing quality system, including the integration of procedures, policies, and plans across all system components.Education and Experience:
Education:
Minimum of a Master's degree in a relevant field.Experience:
At least 10 years of relevant work experience. Several years of management experience.Compensation:
We offer a competitive salary, exceptional social benefits, and a stimulating work environment with diverse responsibilities in an international context. The minimum annual salary for this position is EUR and varies based on the qualifications and experience of the successful candidate.
About Us:
We are recognized as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD elsewhere. For over a century, we have been innovating for life, developing medicines and vaccines for some of the world's most challenging diseases. Today, our company remains at the forefront of research, delivering innovative health solutions and advancing the prevention and treatment of diseases that impact people and animals globally.
Our Vision:
Imagine waking up each day to a role as significant as helping to save and enhance lives worldwide. Here, you have that opportunity. You can leverage your empathy, creativity, digital expertise, or scientific acumen in collaboration with a diverse team dedicated to bringing hope to countless individuals facing some of the most challenging diseases of our time. Our team is continuously evolving, so if you are intellectually curious, consider joining us and start making your impact today.
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