Job Title: Senior Specialist, Quality Assurance IT

Requisition ID: QUA008876

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 Senior Specialist of IT Quality Assurance will be responsible for the quality/compliance, availability, support, and maintenance of specific Merck Manufacturing Division (MMD) computerized solutions. This included the security controls and requirements for data integrity and its operation in compliance with applicable Merck procedures and policies as governed by the Quality Manual and regulatory requirements. This position will work directly with Business Process or Data Owners and Technology Support & Delivery services over the life cycle of the system. Supporting the preparation, review, and approval of documentation related to validation and quality operation of computerized systems including core requirements, policies, guidelines, SOPs, quality alerts, quality bulletins, white papers, best practices, flow charts, and training with the focus on driving consistency of requirements and system function across multiple sites, multiple technologies, and multiple geographies.

Additional responsibilities will include(but not limited to):

Limited supervision required in day-to-day activities. Relevant experience with emphasis on functional and technical leadership. Business engagement skills, an ability to collaborate with both technical and non-technical roles. Experience in IT Project delivery with focus on operation / governance. Strong stakeholder management and engagement skills with demonstrated success in Change Management. Up to speed on technology with ability to understand new/changes and provide guidance on possible solutions. Ability to understand business needs and map to IT technical solutions. Manage relationship with internal IT, business clients, and all stakeholders. Strong facilitation and consulting skills. Experience in managing third-party vendors and development partners in a global environment. Review of audit or inspection reports, responding to findings, and taking appropriate actions to ensure GMP compliance. Manufacturing, Shop-floor, Laboratory, Supply Chain Management or related experience. Work in dynamic environment and global teams. Leading/participating on global projects. Experience working across countries in a multi-cultural environment.

Qualifications

Education Minimum Requirement:

Bachelor's degree in Science, Information Technology, Engineering, or related areas of study.

Required Experience and Skills:

At least 5 years of experience working in a quality and/or compliance oversight role in the pharmaceutical/biotech industry. Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance or auditing to GMP regulations. Prior experience in leadership role delivering validated solutions, regulated application support or vendor oversight role. Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
Preferred Experience and Skills:
GAMP or ICH Validation Guidance
Good understanding of Information Technology operations and maintenance.
CISA, CISP Certification and knowledge of frameworks established under COBIT and ITIL
Six Sigma Green Belt Certification


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.

Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: No
Company Trade Name: Merck