Director Medical Device & Combination Products Quality System Improvement Program 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.
The individual selected will report to the Executive Director Medical Device and Combination Product Quality (MDCPQ) Quality Systems Improvement Program (QSIP) lead, responsible for independent support of MDCP compliance support of Medical Devices including the device constituent part of Combination Products quality system improvements. This position will interact with cross-functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business solutions or audits of data, information, procedures, and systems to ensure compliance with Medical Device and Combination Product Current Good Manufacturing Practices (CGMPs), other worldwide regulations and Merck requirements. In addition, the MDCP Quality Director is responsible for planning and program execution relating to MDCP QSIP workstream.
Primary Responsibilities Include:
- Drives maintenance, knowledge transfer, and as needed development of Merck’s Device specific Quality Management System.
- Participates on Merck teams supporting MDCP CGMP and quality issues related to pure medical devices and the device constituent of a combination product.
- Works with External and Internal Partners to ensure that effective and robust MDCP Quality Systems and Quality management are in place.
- Supports the development and implementation of MDCP Quality metrics, procedures and guidelines, as needed.
- Provides training and coaching to initiate quality improvements within Development, Operations and Quality, as needed.
- Drives the development/revision of policy and procedures for MDCP Quality and /or supported areas.
- Supports preparations of regulatory agency discoverable documentation with focus on relevant MDCP regulations and Quality system requirements.
- Remains informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards. Maintains an expert level of knowledge related to a specialized area of expertise.
Education Minimum Requirement:
- B.S., M.S., and/or Ph.D. degree in an appropriate Science or Engineering discipline. Minimum of fifteen (15) years’ experience with MS / BS or five (5) years’ experience with Ph.D. in pharmaceutical or engineering with medical device or combination product experience.
Required Experience and Skills:
- Expert knowledge of pharmaceutical and/or medical device regulations and/or compliance in a specialized area with experience in their application, including current GMPs for combination products.
- Demonstrated ability to work effectively in teams.
- Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others.
- Effective written and oral communicator.
- Able to speak up and contribute in a team forum.
- Able to apply prior experiences and learning's in new settings, even if these are unfamiliar.
Preferred Experience and Skills:
- Working knowledge of technical aspects of device development and commercialization.
- Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset.
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 email@example.com.
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Visa sponsorship is not available for this position.
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Job: Quality Engineering
Job Title:Dir, Quality Systems & Compliance
Primary Location: NA-US-NJ-Whitehouse Station
Other Locations: NA-US-New Jersey, NA-US-Pennsylvania
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 3
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: New Jersey
Job Segment: Medical, Manager, Law, Pharmaceutical, Engineer, Healthcare, Management, Legal, Science, Engineering