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.
Supporting the Director of Global Computer Management will be responsible for management of the MMD Global Automation Systems Team. Provides regulatory guidance and provide consulting and guidance to IT Business Teams as "System Owners" by developing validation strategies and documentation in a highly regulated areas that are controlled by computerized systems.
This position will provide IT consulting and guidance to IT groups looking for regulatory IT solutions. This at times will include looking for opportunities to reach out beyond the department's scope to actively seek out opportunities to leverage strategies that are both effective and efficient. In addition this position will actively seek out teaming opportunities with other parts of the business to drive consistency and to harmonize the Merck approach to system development, compliant validation strategies, and a consistent understanding of Merck's approach to IT solutions. Position Overview - Basic Functions & Responsibility
Closely work with IT to assure regulatory compliance for all enterprise computer systems and to assure a constant state of regulatory readiness, for assigned IT Applications.
This position will have input to assigned sections for the Quality Manual (QM), Quality Management System (QMS) Computerized Systems Validation Chapter and all related documentation, web sites and training materials for the control of IT systems business ownership of the assigned application. In order to be successful this position will proactively seek the collaboration of the IT teams, the business teams and the process teams to bring clarity to the project team by providing clear and transparent consulting and guidance to a successful deployment of the application. This will require close collaboration with the IT Compliance team.
Proved guidance for projects to maximize efficiencies aligned to customer need with effective and efficient processes.
Develop and manage risk based strategies to provide efficient and effective validation of regulated IT systems. This will require a deep understanding of the MMD System Development Life Cycle (SDLC), GAMP 4 & 5, PIC/s, 21 CFR Part, 211, 820, 11, Annex 11 and developing and future regulations. Prior use and expertise in these guidelines is critical.
Act as the liaison between IT Compliance and IT groups, business functions that develop and use enterprise technology. This will include the collaboration of MRL, MMD, Human Health, Animal Health, subsidiaries, Merck strategic partners and vendors. This position will at times require support at the site level to resolve problems and provide regulated guidances.
Responsible for Quality Projects as assigned by the Director for IT Compliance.
Responsible for the management of IT Compliance, Enterprise staff, teaming with Human Resource, training of staff, assuring that staff members are kept current on IT Training for new technologies, applications and regulation.
The ability to adapt and maneuver through a rapidly changing environment. Qualifications: Education Minimum Requirement: Required Experience and Skills:
Preferred Experience and Skills:
- Regulated IT System Ownership experience
- Degree Preferred, but similar experience a plus,
- Prior Site and Global Quality experience in an FDA or EU regulated Pharma, Vaccine or biologics, API manufacturing. Prefer a minimum of 10 years' experience
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. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement