Job Description

Sr. Manager, Computer System Validation (QA) - 1

Allendale, NJ 07401

MUST BE A US CITIZEN OR A GREEN CARD HOLDER.

This is NOT a generic IT or Software support role. 8 years of FDA-REGULATED, GMP-RELATED ENVIRONMENT IN BIOTECH OR PHARMA OR MEDICAL DEVICE industry is a MUST.

MUST-HAVE: Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4.

This position has no direct reports at this time.

The Sr. Manager, QA Validation Computerized Systems will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Hand-on validation problem-solving.

RESPONSIBILITIES

• Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.
• Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.
• Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements
• Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications.
• Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports.
• Coordinate implementation validation/qualification strategies and serve as the subject matter expert.
• Present project status reports to management as well as project teams.
• Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes.
• Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
• Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report.
• Support internal, client, and regulatory audits and inspections.
• Generate or review/update computer system related policies, procedures, templates, forms, etc.
• Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures.
• Performs other quality system related duties as necessary.

Required Knowledge, Skills, and Abilities: (Submission Summary:

1. Bachelor’s Degree in a Scientific or Engineering discipline

2. 8 + years of experience working in an FDA-regulated, GMP-related environment. Pharma, Biotech, Medical Device industry.

3. Implementation and change management of QMS (Quality Management System) and LIMS (Lab Information Management System).

4. Eight (8) + years of computerized system experience with IT compliance/validation/qualification activities.

5. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.

6. Comprehensive knowledge in Software Validation and Data Integrity Principles.

7. Demonstrated experience, results, and accomplishments in QMS (Quality Management Systems) and LIMS (Lab Information Management System) system implementations.

8. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.

9. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.

10. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)

11. Knowledge of Software Risk Management Principles and tools.

12. Knowledge and proven ability working with Risk Management methodologies and tools.

13. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4.

14. Knowledge of PMDA regulations a plus.

15. Experience with application system validation and infrastructure qualification.

16. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus.

17. Experience with writing and approving Standard Operating Procedures and Quality Standards.

18. This is NOT a generic IT or Software support role. 8 years of FDA-regulated, GMP-related environment in Biotech or Pharma or Medical Device industry is a MUST.

19. Salary Expectation? (Salary Range: $121k - $130k)

20. Must be a US Citizen or Green Card holder.

21. Complete Current Address?

Additional Pre-screen questions

1.) In which industries have you been responsible for QMS implementation, validation and compliance?

2.) Please list name of the companies you have worked for that were FDA-regulated and GMP-related environment.

3.) Please share names of QMS and LIMS (software vendor and product name) that you implemented or managed (changed/updated)?

4.) What types of system qualification documents have you created or reviewed/approved? For example, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports, etc.

5.) What is the level of your proficiency with GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4.?

6.) What activities are you involved in on a daily basis? Despite the title, this is an individual contributor role with no direct reports– are you comfortable performing hands-on responsibilities on a day-to-day basis?

7.) What are your compensation expectations?

8.) In peak traffic hours, how much time will it take you to commute to 4 Pearl Ct, Allendale, NJ 07401?

9.) Are you currently employed at the recently listed company in your resume? If not, why? If so, why are you looking for a transition?

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