Associate Director – IT Quality Audit Job - United States
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 Associate Director of IT Audits is responsible for the strategy, design, implementation and operation of the Internal Audit and Vendor Assessment programs within Merck’s Manufacturing Division (MMD). This position will implement a risk-based approach to ensure required IT controls are in place on GMP computerized systems that could potentially affect patient safety, product quality, and data integrity. This role will drive continuous improvement by proactively identifying quality and compliance exposures and tracking remediation opportunities.
- Develop, Implement and Lead the IT Internal Audit and IT Vendor Assessment programs across MMD. Internal audits of computerized systems include both enterprise and manufacturing site systems. External audits include suppliers providing software and IT services to MMD.
- Harmonize the IT audit program with the Quality Systems Improvement Program (QSIP)
- Collaborate with key stakeholders in the program development that includes Global Quality Operations, IT, CISO, Procurement, Engineering, and Merck’s manufacturing sites
- Ensure a risk-based approach towards profiling and selecting internal and external (vendor) audits/assessments.
- Develop procedures to deliver audit programs.
- Manage overall internal and vendor audit and assessment plans, schedules, communications, and customer expectations
- Facilitate agreed objectives regarding audits and audit-readiness with GQO colleagues / IT leadership / Corporate peer groups and negotiate collaborative delivery of specified objectives
- Execute internal and external audits/assessments globally on behalf of GQO surveying for compliance with regulatory requirements and company policy while leveraging IT Risk Management & Compliance (RM&C) principles.
- Deliver audit reports, including corresponding findings and remediation for tracking in a management reporting system.
- Ensure responses to each audit observation including corrective actions and/or process improvement element(s).
- Manage associated audit process and customer service exceptions
- Monitoring/Reporting service metrics (SLAs)
- Manage escalations and visibility of audits and assessment outcomes
- Provide quality & compliance consultancy and expertise to GQO, IT and MMD colleagues
- Manage and/or leads other ad-hoc GQO-IT projects and initiatives
- Provide training delivery for audit and assessment programs
- Identify and implement continuous improvement opportunities
- Liaises with other GQO audit and compliance groups and Corporate Internal Audit to coordinate global IT audit schedule and agree on audit scope criteria
- Recruit and manage 2-4 audit resources to implement and deliver the services to customer.
- Establish staff objectives and manage multiple projects / ongoing work activities of high complexity within GQO and across MMD divisions that have an impact to Merck
- Mentor junior audit staff as appropriate
- Monitor quality metrics and audit trends, identify compliance issues and determine opportunities for quality improvements within GQO customer areas.
- Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions to effectively develop and advance audit strategies.
- Requires approximately 50 – 75% domestic and International travel for up to two weeks in duration.
Education Minimum Requirement:
- Bachelor's degree in Science, Information Technology or equivalent IT experience related to IT Systems Development, Implementation and/or IT Operations.
Required Experience and Skills:
- 7-10 years of auditing experience in a highly regulated environment. Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system auditing for compliance to GMP regulations
- 3-5 years of experience in delivering validated IT solutions or an application support role
- Familiarity and practical experience in the implementation of quality systems in a pharmaceutical or biotechnology manufacturing environment.
Preferred Experience and Skills:
- Good understanding of a IT technology operations
- 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 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:
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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:Assoc. Dir, Quality Assurance
Primary Location: NA-US-NJ-Whitehouse Station
Other Locations: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New Jersey
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