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Senior Specialist, Artwork Quality & Compliance

Requisition ID: REG004336

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 Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Artwork Senior Specialist is responsible for providing the quality and compliance expertise to support uninterrupted product supply. He/she will be supporting the Artwork business processes (internal Merck divisions and external business partners) through global procedures and through continuous improvement activities. The corporate Artwork End-to-End (E2E) Quality Lead will be the mentor for this position in order to provide strategic guidance and the real time decision making.

This position supports the global divisional Artwork projects , the harmonization of practices across the manufacturing sites and the major transformational initiatives towards digital Artwork solutions and towards streamlined processes that will drive more End-to-End (E2E) efficiency and that will continuously enhance the compliance posture of the company.

The Senior Specialist will support the proactive and corrective actions to prevent any artwork errors and to increase the robustness of the End-to-End (E2E) Artwork management . His /her technical skills associated with a good oversight of the processes will secure the built-in quality and will propose standardization across the sites.

The expected leadership will ensure that direction is given to the cross-functional, cross-divisional Artwork Community of Practices and strategic corporate projects (acquisitions, divestitures, serialization, network, product launches, E-label, etc.). The innovative mindset will support the fit for purpose solutions, the Artwork Management System to operationalize the GMP requirements in close collaboration with the end users and stakeholders. The role will also contribute to the new Quality Management system development and deployment for Artwork. This will cover participation to the design and implementation of the processes , the procedures, the instructions and the R&R associated with the Artwork topic.

Qualifications

Education Minimum Requirement:

  • A Bachelor's Degree in Life Sciences, Engineering or related relevant discipline

Required Experience and Skills:

  • Minimum of Five (5) years of experience in Artwork management.
  • Minimum of Seven (7) years of experience in an FDA and/or EU regulated pharmaceutical environment; preferably in quality roles and/or in Global Quality.
  • Lean and continuous improvements techniques qualified (Green or Black Belt certification preferred)
  • Experience in Quality risks management
  • Subject matter expertise in artwork, labeling and components
  • Experience with multi-level and/or cross-divisional interactions in a multi-cultural setting
  • The ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across markets, sites & functions
  • Facilitation and project management skills.
  • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
  • Ability to provide innovative ideas to improve quality and compliance that create value

Preferred Experience and Skills:

  • Demonstrated leadership in Quality Compliance discipline and in-depth knowledge of global health authorities regulations and requirements, with the ability to effectively translate and communicate these requirements


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.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

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:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.

MMDHJ

Job: Regulatory Compliance
Other Locations: Durham-RTP, NC, US; Kenilworth, NJ, US; West Point, PA, US; Elkton, VA, US
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: None
Company Trade Name: Merck

Senior Specialist, Artwork Quality & Compliance

Upper Gwynedd Township, PA
Full Time

Published on 06/25/2019