Associate Director, Regulatory Affairs CMC Business Process Support Job - United States
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Manager, under the broad guidance of the Director Regulatory Affairs, will be responsible for management of Regulatory CMC business processes associated with clinical and/or commercial manufacturing change control systems expanding all phases of product life cycle (development, commercialization, and deletion/divestiture). The candidate will manage a team of subject matter experts responsible for day-to-day operational activities as well as process improvement initiatives within the manufacturing change control and the health registration management system. He/she will collaborate with key system owners within Merck Research Laboratories and Merck Manufacturing Division to define/refine CMC functional requirements that are integrated and aligned with overall business process improvements and technology initiatives. This includes the development of functional project plans, user requirements, documentation, training materials, and effectiveness measures. The candidate will be accountable to achieve integrated, consistent and value focused Business Processes, reduce waste and implement meaningful process indicators; to align information technology with organizational and operational needs of the CMC team; to adjust processes to increase conformance, efficiency, and user experience; to ensure consistency in practices; to promote operational excellence across headquarters/international/site CMC teams; and, to deliver integrated digitized data management solutions. The candidate will participate in external discussion groups, societies, and/or working groups to promote harmonization and improve business processes to leverage digital data management.
- Bachelor’s Degree required (preferred post graduate degree).
- Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline
- Minimum 10 years relevant pharmaceutical industry, experience with change control and/or deviations management (demonstrated Complex problem solving)
- Project management
- Prior supervisor/manager experience
- Minimum 5 years CMC experience (direct or indirect)
- Lean six sigma, superior written/oral communication,
- Fluent in English language
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Regulatory Affairs - CMC
Job Title:Assoc. Dir, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Regulatory Affairs, Chemical Research, Law, Business Process, Manager, Legal, Engineering, Management