Director, Clinical Supply QMS
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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
This position reports to the Clinical Supply Quality Management System (QMS) Head, Global Development Quality and is the Clinical Supply Continuum Owner of one (1) of two (2) QMS Chapters (defined below) playing a key role in the design, implementation and long-term maintenance of a new QMS, including Quality Standards and Global Standard Operating Procedures, for all Clinical Supply and Commercialization sites performing Clinical Supply functions within the Merck Global network.
In addition, the responsibilities of this position include, but are not limited to, the following:
- Act as a cross-functional leader and Clinical Supply subject matter expert to hold the overall responsibility for one of the following QMS Chapters & associated topics:
3.1. Training & Qualification
3.2. Data governance and GMP records
3.3. Computerized systems
3.4. Change control
3.5. Deviation Management
3.6. Batch Disposition
3.7. Annual Product Review
3.8. Audit and Inspection
Chapter 6 – Manufacturing:
6.1. Facility & Equipment
6.2. Environmental Control
6.3. Materials Management
6.4. Manufacturing Practices
6.5. Sterile Requirements
6.6. Packaging & Labeling Practices
6.7. Good Distribution Practices
- Own the development, implementation and ongoing maintenance of a new Clinical Supply Continuum for one of the above-mentioned QMS Chapters that is based on regulatory requirements while allowing the greatest flexibility to allow for a rapid, effective and compliant pharmaceutical development process and ensuring phase appropriate needs are considered to minimize unneeded requirements especially during early development manufacturing.
- Act as a change agent to stimulate, facilitate and coordinate the adaptation of the QMS redesign contributing to the overall the transformation of Merck’s business and culture.
- Accountable for identification of Clinical Supply specific requirements for responsible areas and implementation at all sites with Clinical Supply functions.
- Help define appropriate means for Commercialization sites in the Merck network to simply and effectively operate in a hybrid Commercial and Clinical Supply space.
- Liaise with and leverage the expertise of commercial regulatory intelligence personnel and chapter owners, the Clinical Supply Regulatory Intelligence Lead as well as external bodies to set direction for GMP requirements for Clinical Supply areas and ensure current regulatory requirements are met using, as well as developing, industry best practices.
- Significantly harmonize diverse Clinical Supply site practices by developing efficient, yet flexible Global SOPs and effectively implement at all sites with Clinical Supply functions.
- Identify areas of continuous improvement for simple lean quality system deployment, linked to Merck Production System (MPS), ensuring best practice sharing while driving improvement within the Clinical Supply GMP network.
- Bachelor’s Degree in an appropriate scientific or engineering field of study
- Degree Concentration /fields of study: Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology
- An advanced degree
- Minimum of ten (10) years’ experience in the Pharmaceutical or equivalent industry with at least 5 years within the development space
- Strong technical knowledge, skills and experience in R&D activities, coupled with the ability to interact with technical subject matter experts on one of the defined QMS Chapters.
- Strong compliance mindset and knowledge of GMP regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment
- Flexibility to travel up to 25% both domestic and international
- Experience directly related to Quality Assurance or Quality Control
- Significant experience directly related to the development of Quality Standards and core requirements for Market Supply and / or Clinical Supply
- Excellent verbal and written communication skills as well as presentation skills
- Strongly developed cross-functional teamwork, collaboration, influencing and negotiating skills within and across divisions as well as within matrix organizations
- Multiple connections within industry to keep abreast of current regulatory trends.
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 Assurance
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck