Sr. Specialist - Third Party Quality Management)
The mission of Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.
Working in the Finished Goods Platform TPQM (Third Party Quality Management) department within our Research & Development Division. The Packaging Liaison will be responsible for serving as the quality representative for and providing quality oversight of contractors performing various GMP activities supporting the production of clinical supplies, on behalf of our company.
Key responsibilities include:
Quality oversight of nominated Third-Party Vendors in the Clinical Finished
Goods (FG) Platform includes:
Reviewing and approving of contractor-initiated investigations associated with deviations.
Negotiating site and global Technical and Quality Agreements.
Participating in contractor GMP audits and assisting with audit CAPA reviews/acceptance.
Supporting internal cross-functional investigation and resolution teams.
Assisting in contractor “deep dive” quality assessments such as data integrity and cross-functional contractor performance reviews for the platform.
Collaborating with external contractor quality and technical personnel.
Interacting with Quality Disposition, Global Clinical Supply groups and Procurement on strategic objectives linked to external contractors including GMP qualification as well as site/project selection.
Working on projects related to quality oversight of vendors such as development of key quality performance metrics.
Serving as a quality representative in oversight and business review meetings with members from our company and contractor personnel to discuss projects, financial, operational/quality, and overall performance topics.
In addition to the job specific responsibilities discussed above, the Packaging Liaison is expected to independently execute the following:
Key activities this position would encompass:
Global maintenance and accuracy of the Development Approved Vendor Listing.
Establishment, management and impact assessment of supplier related changes and identification of opportunities for further improvements and streamlining.
Support of cross functional impact assessments using risk-based tools for significant vendor related events.
Plans and facilitates Quality-related process reviews and/or investigations under minimal.
Communicates with senior management within our company's and the contractor organization.
Facilitates and/or prepares cross-functional management presentations.
Makes independent decisions and acts with authority to carry out required actions.
Identifies trends and/or potential compliance gaps and proactively leads the resolution of issues affecting quality and efficiency.
Interprets regulatory requirements for various audiences, including source area management, and facilitates communication of these requirements across stakeholders.
Education Minimum Requirement:
Bachelor’s Degree in Engineering, Biology, Chemistry or related field.
Required Experience and Skills:
A minimum of seven (7) years of relevant experience within the pharmaceutical industry OR
Advanced Degree with a minimum of five (5) years relevant experience.
Preferred Experience and Skills:
Experience interacting with regulatory officials and external auditing parties.
Strong compliance knowledge of EU/US/ROW regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment.
Strong understanding of regulatory agency regulations and requirements.
Ability to independently interact with external auditing parties.
Possess drug development knowledge.
Demonstrated knowledge of continuous improvement methodologies; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions, and follow through on implementation.
Strongly developed cross-functional teamwork, collaboration, influencing and negotiation
Demonstrated skills in communicating (oral and written) effectively with diverse individuals/groups.
Demonstrated time management skills, ability to conduct well defined projects within discipline or area of expertise.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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.
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Flexible Work Arrangements:Remote Work, Telecommuting
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