Associate Director, Computer System Validation 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 Computer System Validation (CSV) CoE Associate Director, reports to the Director, WP Site Quality Head and supports development quality activities at the West Point Site. This position is critical to maintaining the clinical supply chain for investigational product. Specifically this position provides line management oversight to the CSV CoE group which provides review and approval of regulated (GLP, GMP) Merck System Development Lifecycle (SDLC) deliverables including SOP’s, Quality Assurance Plans, Requirements Specifications, User Acceptance Test Plans and Summary reports, Quality Assurance Summary Reports, System Retirement / Decommissioning Plans and summary reports, IT Events, deviations, CAPA’s, Change Plans and Periodic Reviews – ensuring compliance with Regulatory (US and EU) and Merck Requirements.
Responsibilities include, but are not limited to:
- Maintain an expert level of knowledge relative to technical expertise and GMP/GLP requirements and industry trends as described in applicable worldwide regulations.
- Provide CSV Quality support for assigned Local systems in West Point PA, Rahway and Kenilworth NJ
- Schedule, perform, report and facilitate compliance Audits (Regulatory Agency, Internal). Proposes solutions to compliance issues or Audit comments with client areas.
- Perform System Assessments including GxP applicability, 21 CFR Part 11, and Data Integrity compliance.
- Provide point of contact consultation as subject matter expert relative to Computer System Validation, Data Integrity and Regulatory Expectations (GLP, GMP, MHRA, EU) to client areas and IT support.
- Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist support areas in SOP and Quality-Related system development and approval
- Identify Training needs and oversee, develop and/or conduct GxP, Regulatory or SDLC orientation sessions for internal staff or Client groups
- Support preparations for regulatory agency inspections
- Proficiency in use of Change Control tools including Remedy and PSQTS
- Collaborate with Peers (including other CSV Quality organizations), sharing and aligning best practices and developing solutions to identified problems/concerns
- Represent CSV CoE on inter-departmental and cross-functional teams, ensuring flow of information and providing quality guidance.
Education Minimum Requirement:
- B.S. in appropriate Science, Engineering or IT discipline (chemistry, biology biochemistry); advanced degree preferred.
Required Experience and Skills:
Current or previous supervisory / management experience.
- Minimum 8 years experience in Pharmaceutical or Biotechnology industry
- Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering
- Strong leadership skills with the ability to work and effectively communicate with a wide variety of clients including Scientists, Lab Managers, IT and Technical experts, and senior Quality managers within division and cross-functionally
- Demonstrated analytical, problem-solving, negotiating and excellent communication (oral/written) skills are required.
- A working knowledge of current Good Manufacturing Practices, Good Laboratory Practices and technical/scientific understanding of support areas are required
- Computer skills; knowledge and competency in PowerPoint, Excel, and Word
- Ability to independently manage multiple priorities and projects
Preferred Experience and Skills:
- Computer system development methodology is preferred
- Previous GMP Quality role (quality Systems, validation, compliance, audit, assurance)
- Familiarity with R&D or clinical supply areas and processes
- Regulatory or QP inspections
- Superior skills in collaboration, teamwork, conflict management
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:
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Clinical, Non Clinical Quality Assurance
Job Title:Assoc. Dir, Quality Assurance
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biochemistry, Developer, Manager, Biotech, Engineer, Science, Technology, Management, Engineering