Senior Specialist, Information Technology Quality Assurance Job - United States
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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 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.
Education Minimum Requirement:
- Bachelor's degree in Science, Information Technology or equivalent.
- IT experience related to Computerized Systems Development, Implementation and/or IT Operations.
Required Experience and Skills:
- 7-10 years of experience in regulated pharmaceutical manufacturing or laboratory environment.
- Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance or auditing to GMP regulations.
- 5 - 7 years of experience in leadership 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:
- 2-3 years in a leadership capacity with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
- 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
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.
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
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Qual Assurance & Ops Generic
Job Title:Sr. Spclst, Quality Assurance
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Whitehouse Station
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biotech, Pharmaceutical, Information Technology, Laboratory, Consulting, Science, Technology