Associate Director, Quality Assurance Change Control

Vor 3 Tagen

Wien, Österreich Merck Vollzeit

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a growth and improvement minded Quality Management System Change Control Associate Director that can help drive our Strategic Operating Priorities.
- Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
- Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
- Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
- Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
- Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Opportunities and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us

**Additional Key Responsibilities**
- Work with the Change Control Core Team, sites, functional groups and additional stakeholders to sustain and make continuous improvements to the Change Control Quality Management System (People, Process, System)
- Provide support to the change control quality system codified in our Company's Quality Manual and monitor the performance of the quality system and drive continuous improvement efforts
- Monitor site adherence to the company’s codified change control quality system, advocate standard work across all sites, perform periodic Health of System analyses, and assist sites in the troubleshooting of change control issues
- Monitor health authority regulations and ensure that relevant regulations are incorporated into the change control Quality Management System documents.
- Author and maintain global change control topic documents. Ensure procedures are aligned with other Quality Management System topics and functionality updates to the IT platforms supporting the change control process
- Interact with Batch Disposition personnel, clinical, Integrated Product Data team and Regulatory scientists to drive further integration of these processes with change control
- Develop and maintain global training materials and deliver training to our Manufacturing Division personnel
- Direct a community of practice for Change Control and manage the content of information placed on the CoP website
- Troubleshoot network change control issues and provide guidance on resolution
- Interface with Information Technology group to identify system improvements that enhance the efficiency and effectiveness of the change control process
- Conduct Health of System analyses using relevant key performance indicators

**Education**
- Bachelor** **degree in Science or Engineering or Master degree

**Required**
- Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect
- Ethical and strong communications
- Five years in pharmaceutical and/or vaccine manufacturing environment
- Change Control and the IT systems enabling change control
- Continuous improvement mindset and bias to action is important for this role

**Preferred**
- Background in US and international GMP policy and regulations
- Demonstrated management/leadership skills
- Working knowledge in Quality Risk Management tools and principles

**Travel Requirements**
- Up to 20%

Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals 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.

**Who we are**

We are known as Merck & Co., Inc., Kenilworth, 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 opportuni

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