Topic Owner, Analytical Standards
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Topic Owner - Analytical Standards (TO–AS) position is critical in Merck’s effort to create a simplified, integrated, user-centric Analytical Standards (Test Methods and Specifications) as part of the QMS Lab Controls chapter for our human health products.
The TO–AS is responsible for providing leadership and direction for the development and maintenance of processes, procedures and corresponding controlled documentation and systems within QMS Chapter 7 – Lab Controls, Topic 7.1. The topic encompasses defining requirements and processes to develop execution level method templates and redesigned specifications, associated Global Procedures and other supportive documents. The position also involves enhancing the process for development, review and approval of commercial specifications for use in Quality Laboratories, including working with new IT solutions to manage global as well as country-specific specifications.
The TO-AS is also responsible for ensuring the end-to-end life cycle process for managing commercial test methods and specifications is well defined, there is a robust quality management system in place to monitor the process and that any gaps are identified and managed to completion.
- Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities and Accountabilities
- The 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.
- Advanced Degree in Life Sciences, Engineering or related relevant discipline.
- Minimum of 10 years’ experience in the FDA and/or EU regulated pharmaceutical laboratory environment; preferably leading Quality Control laboratory operations at a site; experience working with pharmaceutical, vaccines and biologics regulations and testing methodologies highly preferred.
- In-depth knowledge of analytical techniques used in commercial testing of raw materials, excipients, drug substance and drug products required, preferably with different product modalities (e.g., vaccines, biologics and pharmaceutical products).
- Experience leading Quality Control laboratory operations at a site
- Working knowledge of end-to-end laboratory processes and systems (e.g., LIMS, Empower, etc.)
- Familiarity of Data Integrity considerations and requirements
- Subject matter expertise in regulatory requirements and expectations for laboratory and documentation controls.
- Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements with the ability to effectively translate and communicate these requirements.
- Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites & functions.
- Excellent facilitation and project management skills, with strong verbal and written communication 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 & 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 MMD network.
- Experience implementing global IT systems related to laboratory operations strongly preferred.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Quality Operations
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck