Executive Director, Global Change Control COE ( MERCUSR119391ENUS)
Our Manufacturing & Supply Division is dedicated to being 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.
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant linked to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
This position is critical in our Company’s effort to create a simplified, integrated, user-centric approach to align our global change management system to the current regulatory environment. A modernized change management system that synergizes with industry and health authority expectations for post approval changes allows our Company to enable consistently compliant product quality, continuous improvement and effective life cycle management for our human health products.
Act as a cross-functional leader to Simplify and Standardize our change management strategy for the oversight of post approval changes for now and the future. This Executive Director will ensure cross functional alignment between CMC and Manufacturing Quality and act as change agent to MMD’s Global Quality Compliance, including culture and behavior.
A functional leader in the Global Quality team for developing and executing strategies to address the evolving regulatory climate related to cGMP compliance.
Hold the overall responsibility for enabling a strategy to modernize how our Manufacturing Division handles the management of post approval changes by decreasing the complexities of the system while ensuring that our Company procedures remain compliant with cGMP requirements.
Utilize an enhanced science and risk-based approach to establish regulatory strategy and manage conformance to global registrations.
Work with policymakers and key opinion leaders in Health Authorities and Industry.
Research and benchmark the regulations and best practice guidances/white papers (e.g., ICH guidances) that are relevant to the management of post approval changes.
Direct the transformation of Company policies and procedures to align with the current regulatory landscape for management of post approval changes.
Enable the development of regulatory strategies to manage post approval changes under a mature QMS that utilizes product and process comprehension, use of quality risk management and a mature quality culture combined to ensure that product quality, patient safety, and adequate supply to patients are maintained.
Develop a network to engage with regulators, industry forums and key external partners to ensure Company policies and processes stay aligned with the regulatory climate around manufacturing quality maturity including but not limited to post approval changes and advances in technology to support the reduction of drug shortages.
Ensure engagement with senior leaders across our Company to disseminate information and novel policies for feedback and execution of strategies.
Participate in industry conferences and other forums such as working groups to influence and advocate our Company's position regarding harmonized compliance regulatory requirements.
Lead interdisciplinary teams that will demand exceptional support, thoroughness and attention to detail, excellent verbal and written communication in addition to efficient execution.
Operate in a highly ethical and respectful manner to build and maintain relationships with all levels of the organization and external stakeholders.
Is able to travel ~ 25% - 50% of the time.
At least a Bachelor's degree in science, engineering, or related areas of study.
Thorough understanding of regulatory requirements for drugs, devices, biologics, including quality risk management and knowledge management, in particular with regards to state-of-the-art expectations for the quality organization and management responsibilities.
Minimum of 10 years experience working with regulatory agencies which includes building successful collaborations across Agencies and with global regulators with a proven record of consensus building to implement novel policies and initiatives.
Expertise in FDA and international rules, regulations and policies such as ICH guidance documents, Code of Federal Regulations, regulatory agency and/or PIC/S guidances, and Food Drug Administration Safety and Innovation Act (FDASIA).
Ability to accurately interpret and apply regulatory expectations for a robust and compliant quality organization and management responsibilities in a drug, device and biologics manufacturing environment.
Strong project management skills.
Capable of working and communicating effectively with all levels of the organization globally.
Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.
Proven ability to influence effectively without hierarchical authority multi-functional professionals to drive harmonization and proactive compliance.
Proven ability to effectively initiate and drive change across the Manufacturing Division's network.
Self-motivated with a high degree of ownership and accountability for results.
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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
Invent. Impact. Inspire.
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