Merck Director, Quality Management System | Batch Disposition in Topeka, Kansas
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 committed 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 Director, Quality Management System | Batch Disposition 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 Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Summary, Focus and Purpose
This position is critical in our Company's effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products, with an objective to enable consistently compliant product quality, continuous improvement and effective life-cycle management.
The Director, Quality Management System | Batch Disposition is responsible for providing leadership and direction for the development and execution of processes and procedures for Batch Disposition. Development and maintenance of procedures will be implemented in accordance with QMS Chapter 1 – Quality Management Systems Operation. The Director is also responsible for ensuring the E2E (End-to-End) life cycle process for their QMS is well defined per the attributes of a quality system, there is a robust management system in place to monitor the process, and that any gaps are identified and managed to completion. More specifically:
Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities and Accountabilities
Organization and Infrastructure to support the execution of the processes are defined and installed
Metrics are developed for the ongoing evaluation that the system is working as intended, reviewed by the appropriate levels of management, and used as a basis for continual improvement
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Lead the design, development, and implementation of the Batch Disposition topic area within the Quality Systems and Compliance chapter (Chapter 3). Define the strategy for global requirements and procedures to drive harmonization of batch disposition processes and systems across the network
Lead cross-functional global teams developing content for the topic, and interface with other chapters/topics, and stakeholders across the network
Work with sub-topic owners and subject matter experts to assess system performance and drive continual improvement
Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS as it relates to lifecycle management of global and site/functional QMS documents and related processes
Provide leadership and technical direction on regulatory requirements for the batch disposition system in the GMP/GDP environment
Monitor global regulations with impact on the batch disposition topic with a focus on developing and sustaining an accurate interpretation of regulatory requirements in alignment with QMS policies and procedures
Help identify, resolve/mitigate, or appropriately escalate any issues or delays in topic content development and or improvements, and ensure all targets are met on time in alignment with quality expectations
As the business owner of several digital systems, actively participate in the identification, test and approvals of IT solutions that enable procedures execution in digital platforms
Drive the development, implementation and realization of permanent inspection readiness for the batch disposition topic
Actively participate in pharmaceutical industry meetings / regulatory symposia etc., to establish industry relationships, leverage industry best practices and benchmarking, stay abreast of regulatory trends, and implement action plans to proactively address potential GMP compliance impact
Bachelor's degree in Life Sciences, Engineering or related relevant discipline
Masters or PhD preferred
Required Experience | Skills | Knowledge
Ten years in an FDA and/or EU regulated pharmaceutical environment, preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality
Principled verbal and written communications
Demonstrated leadership in Quality and Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements
Subject matter expertise in regulatory requirements and expectations defined in ICH Q 10 for Pharmaceutical Quality Systems
Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites and functions
Excellent facilitation and project management skills
Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities, effective time management
Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
Demonstrated ability to make and act on decisions while balancing speed, quality and risk
Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights
Capable of working and communicating effectively with all levels of the organization globally
Proven ability to effectively initiate and drive change across the Manufacturing Division network
Capable of facilitating global forums and maintaining effective Communities of Practice, Common Interest Groups and other Knowledge Management solutions
Experienced with data analytics, development and use of visualization tools to convey performance messaging
Preferred Experience and Skills
- Experience in vaccines, biologics, devices and API regulations
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.
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.
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Expected salary range:
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Flexible Work Arrangements:
Hybrid, Remote Work
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Requisition ID: R231387