Merck Director, Quality Assurance (REMOTE) in Topeka, Kansas
Technical Director, Vaccine Drug Substance Platform, Third Party Quality Management (TPQM) and Due diligence, Global Development Quality is accountable for the overall operational and strategic oversight of third-party contractors and vendors providing contract manufacturing service for vaccine drug substance in assist of our Company’s clinical supply chain.
Key areas of responsibility include defining and driving the quality performance and ensuring compliance robustness on behalf of TPQM across a designated vendor base. This includes supporting the development and execution of a strategic global vision for TPQM and influencing the same for key stakeholder business areas. This role will provide specific quality support and be responsible for supporting the development and driving the execution of the continuous improvement of third-party quality processes within vaccine drug substance contract manufacturers to minimize and mitigate risk to our Company’s clinical development programs.
The position will require an in-depth close partnership with the vendor quality and technical personnel and associated interaction with our company's vaccine development functional area on executing against strategic objectives related to the designated vendor base. This will also include navigating technically highly complex quality related matters, both process improvements and significant quality issues and events. An advanced level of knowledge of the vaccine and biologics therapeutics development process and of the associated stakeholder organizations is required for this role in addition to technical and quality expertise and experience to enable the candidate to carry the necessary level of credibility to the stakeholder areas as well as with the vendors at senior levels to be successful. The position will also participate and provide quality assessment in the due diligence process for business development opportunity and acquisition support.
Execute the daily operational TPQM support for the vaccine drug substance manufacture contractor bases related to the most complex activities that our Company outsources, with the associated potential for high impact to the development portfolio.
Development of and driving the execution of quality strategies, improvement initiatives in line with business drivers and objectives.
Provide assistance to our Company’s Global Auditing group in relation to audits conducted and mitigation activities in regard to audit observations for the designated vendor base.
Interacting cross-functionally and cross-divisionally with senior management on quality/regulatory matters as well as special projects, and externally with inspectors and colleagues in industry in relation to the designated vendor base.
Driving the resolution of contractor / vendor related business practice, Quality and/ or compliance issues of high-impact scope and highest level of complexity on cross-functional and/ or cross-divisional basis in relation to the designated vendor base.
Provision of in-depth technical / quality expertise re; identification of trends and/or potential compliance gaps and proactively leading the resolution of long-standing or significant issues affecting quality and efficiency.
Provide assistance to quality assessment in the due diligence process for business development opportunity and acquisition support.
Education Minimum Requirements:
Bachelor’s Degree in Engineering, Biology, Chemistry or related field.
A minimum of 10+ years of relevant experience working within the pharmaceutical industry or advanced Degree with 8+ years relevant experience.
Required Experience and Skills:
Primary skills include, but are not limited to:
Strong scientific/ technical expertise in Research & Development (R&D) activities, coupled with the ability to interact with and influence scientific subject matter experts and senior leaders on various product initiatives and issues in the therapeutics vaccine development.
Strong compliance knowledge and understanding of regulatory agency regulations and requirements and interpretation and application re; good manufacturing practices (GMPs) to a R&D environment.
Possess deep drug development knowledge; demonstrated ability to facilitate training and learning with colleagues and apply knowledge to enhance the drug development process.
Strong expertise and knowledge in Quality requirement and regulations and deep knowledge and in vaccine development; knowledge in biologics, cell/gene therapy development is a plus.
Demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives.
Demonstrated leadership, including strategy deployment, in a pharmaceutical environment.
Proven track record of delivering tangible benefits from process improvement activities in a pharmaceutical environment.
Demonstrated experience in quality risk management in the pharmaceutical industry.
Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.
Strong demonstrated skills in communicating (oral and written) effectively with diverse individuals / groups.
Interact with regulatory officials and external auditing parties.
This is a remote opportunity
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
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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Flexible Work Arrangements:
Flex Time, Remote Work
Valid Driving License:
Number of Openings:
Requisition ID: R114638