Associate Director, Clinical Supply Compliance Job - United States
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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.
This individual is responsible for the preparation and support for GMP elements of GCP regulatory inspections. This individual would also be a key participant during GCP regulatory inspections to help answer inspector questions, both in a support role as well as representing Investigational Medical Products directly to inspectors. Other responsibilities will be to lead and/or play a large role in various compliance related projects for Clinical Supply areas. Finally, this person will play a backup role for the West Point control substance coordinator role and ensure compliance with DEA needs.
Essential Duties & Responsibilities: Actively track inspection preparation activities and prepare materials needed to present and defend the entire IMP supply chain, from API through the distribution network, culminating with return and destruction records. Ensure needed documents are on hand to defend the study, and make decisions for the level of preparation for any given study. Streamline the preparation process to make it as efficient as possible, while ensuring inspector questions can be answered quickly, completely and accurately.
Manage other compliance projects to help implement management directed projects. Projects may include development of a clinical supply continuum for the quality manual, evaluation of standards for Clinical Supply areas, handling of Quality Alerts and Quality Bulletins, etc.
Learn the controlled substance basics to allow for backup capability in the event that the primary control substance coordinator is unavailable.
- Bachelor’s Degree.
- 10 years in the pharmaceutical industry with at least 5 years in Validation and/or Quality.
- Strong leadership and project management skills.
- Ability to work cross functionally with multiple groups on complex, strategic projects. Able to communicate effectively both verbally and in writing at all levels of the organization within Merck, with collaborators, colleagues, third party vendors, and regulating agencies.
- Quality experience with pharmaceutical finished goods.
- DEA Compliance and emphasis on controlled substance handling and compliance.
- Relevant experience with regulatory inspectors.
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: Qual Assurance & Ops Generic
Job Title:Assoc. Dir, Quality Assurance
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Clinic, Medical, Manager, Compliance, Supply, Healthcare, Legal, Management, Operations