Full Job Description
This position reports to the Director, Clinical Supplies Quality and is critical to maintaining the clinical supply chain via supporting disposition of investigational medicinal product in our clinical supplies inventory system. Specifically, this includes ensuring our clinical supplies are in compliance with current Good Manufacturing Practices and relevant regulatory submissions via direct support for batch release and directing team-based process assessments and enhancements.
Areas of focus of this position revolve around the detailed workings of clinical packaging and labeling activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex / niche supply chains and supply types to support aspects such as Managed Access Programs, Joint Ventures / Collaborations, Independent Investigator-Initiated Studies etc. in addition to standard clinical protocols.
This role will also assist in managing when necessary significant quality events such as formal Quarantine and Recovery actions that require rapid and effective liaison with many internal and external stakeholders, including at senior levels.
Evaluation and/or disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.
Closely partner with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place.
Coordinate and provide guidance in the preparation of procedures, processes and quality improvements where warranted.
Coordinate significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions.
Education Minimum Requirements:
Bachelor’s Degree in Science (Biology, Chemistry or any related fields).
Minimum of 8 years’ experience in the Pharmaceutical or equivalent industry.
Preferred Experience and Skills:
Strong comprehension of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying current Good Manufacturing Practices (cGMPs) to our Research & Development environment.
Computer skills; knowledge and competency in ERP/MES, Trackwise, PowerPoint, Excel and Word.
Ability to manage multiple priorities and projects.
Comprehensive Lean Six Sigma and Project Management skills; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation.
Strongly developed cross-functional teamwork, partnership, influencing and negotiating skills.
Ability to lead teams of a cross-functional and multi-level nature, including senior management representatives.
Excellent verbal and written communication and presentation skills.
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 …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development
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.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
If you need an accommodation for the application process please email us at firstname.lastname@example.org