Quality Risk Management Lead

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 Specialist within the Quality Risk Management (QRM) group will support QRM activities at the Elkton site. Work is executed as an individual contributor or as part of a project team.
The Specialist:
+ Responds to non- standard requests from customers; investigates with assistance from others as needed
+ Explains information and persuades others in straightforward situations
+ Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines
The following are key responsibilities within this position:
+ Responsible to develop and maintain Quality Risk Management (QRM) Expertise
+ Responsible for supporting QRM site deployment
+ Responsible for activities involved in the implementation of a harmonized QRM program including standards, business processes, tools and training for the site
+ Responsible for facilitation of Quality Risk Assessments
+ Responsible for partnering with customers across site, key stakeholders and management, to communicate/escalate and ensure timely and adequate management of quality risks
+ Responsible for maintenance of Site Quality Risk tracking documentation
+ Responsible for identifying and implementing continuous improvement initiatives within the site QRM business processes in alignment with the QRM CoE program, including integration into the quality management system
+ Accountable for review of site level QRM activities
+ Accountable for on-time schedule-based risk reviews
+ Accountable for ensuring that all those involved in QRM activities meet QRM training requirements
+ Support the QRM IT Tool Implementation at the site
+ Support regulatory inspections and audits as requested
+ Collaborates with QRM Community of Practice members across the division
Maintains knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information.
Participates on, or leads teams supporting internal functions and/or evaluating site processes for improvement opportunities.
Education Minimum Requirement:
+ B.S. degree in engineering or related scientific field
Required Experience and Skills :
+ A minimum of 2 years in GMP Manufacturing or Regulatory or Process Engineering
+ Technical understanding of Biologics, Vaccines, and/or small molecules business
Preferred Experience and Skills:
+ Exposed to application of Risk Management tools and methodologies such as: FMEA, PHA, FTA, Risk Ranking and Filtering, etc.
+ Fast learner and can be a change agent
+ Understanding of Merck?s Quality System
+ Shop floor manufacturing experience
+ Project Management experience
+ Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
+ Demonstrated self-starter with capability to develop innovative solutions to challenges
+ Demonstrated facilitative leadership skills and ability to lead cross-functional project teams to deliver results
+ Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
+ Speaks with courage and candor
+ Strong written and verbal communication skills
+ In-depth working knowledge and application of GMPs/GLPs
+ Proven ability to manage multiple projects simultaneously
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:
EEOC Poster at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
EEOC GINA Supplement? at http://www1.eeoc.gov/employers/upload/eeoc_gina_supplement.pdf
OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of it?s manifestations.
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.
Job _Manufacturing Engineering_
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.
Title: _Quality Risk Management Lead_
Primary Location: NA-US-VA-Elkton
Requisition ID: _MAN005699_

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