Manager, QA Computer System Validation
Company: Cymabay Therapeutics
Posted on: May 21, 2023
POSITION SUMMARYThe primary role of the Manager, QA Computer
System Validation, will be to execute processes and procedures to
ensure the compliance and quality of GxP relevant computer systems
and solutions. -The position will provide project and quality
leadership for regulated and critical business systems to ensure
compliance with all applicable regulatory and operational
requirements. The position will act as the liaison between Quality,
Information Technology (IT) and the applicable functional business
departments to ensure GxP compliance requirements are met for
computer systems. This position reports to the Vice President
Quality.ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provides support for the Computer System Validation (CSV)
program, including writing, reviewing, and approving CSV
deliverables such as Change Controls, Plans, Specifications (e.g.,
URS), Traceability Matrices, Test Scripts, and Reports.
- Authors and/or revises CSV procedures, forms, and templates for
- Owns CSV-related Deviations and CAPAs. Manages remediation
efforts related to CSV and Data Integrity.
- Participates in the role of Quality for IT Change Control
- Partners with IT and System/Process Owners to implement and
maintain GxP computerized systems in a validated state and adheres
to Data Integrity principles in accordance with external regulatory
expectations and internal requirements.
- Facilitates Periodic Reviews for systems. Ensures adherence to
the Periodic Review schedule.
- Performs Audit Trail review requirements with IT and
- Provides training for the CSV program to new System/Process
- Supports GxP computer system audits and ensures computer system
vendors are qualified prior to system implementation.
- Partners with IT and external vendors in the validation and
delivery of new IT systems
- Provides validation guidance on data migration (ex CRO to TMF
Archive, SAS data, etc.)
- Provides support during audits and inspections.Complete other
responsibilities, as assignedMINIMUM QUALIFICATIONS
- Minimum 5-7 years in GXP computer system validation
- 7 + Biotech/pharmaceutical/GXP industry preferably in
- Working knowledge of GxP regulations and CSV/CSA principles,
including, but not limited to 21 CFR Part 11, Annex 11, GAMP 5, and
- Knowledge of Quality Risk Management per ICH Q9 and its
application to CSV.
- Proficiency in Microsoft Office, including process
mapping/project management tools such as Lucidchart and
- Veeva experience is a plus.
- Familiarity with ERP and Clinical Data Management systems a
- Understands CSV expectations for implementation and management
of pre, amd cloud-based/SaaS systems
- Maintains awareness of current and upcoming FDA Computer
Software Assurance (CSA) principles
- Excellent verbal and written skills, allowing for an open and
effective dialogue throughout the company.
- Attention to detail and quality are critical to success.
- Highly accountable for the results and outcomes of their
responsibilities and understands the impact of their efforts,
results, and attitudes on others.
- Focused on collaborative work to deliver the most effective
solutions, championing the best ideas of team members, and
assisting where help is needed yet is capable of highly independent
work when efficiency is required.
- Results-oriented individual who is highly motivated, decisive,
flexible, and has the creativity to excel in and contribute to a
rapidly growing company.
- Forward thinking mindset with the ability to manage multiple
projects and identify and resolve issues.EDUCATION, CERTIFICATES,
- Bachelor of Computer Science or related discipline preferred
-The anticipated salary range for the Manager, QA Computer System
Validation, who will work in Newark, California is $140,000 -
$160,000. - The final salary offered to a successful candidate will
be dependent on several factors that may include but are not
limited to the type and length of experience within the job, type
and length of experience within the industry, education, etc. -
CymaBay is a multi-state employer, and this salary range may not
reflect positions that work in other states. -Powered by
Keywords: Cymabay Therapeutics, Newark , Manager, QA Computer System Validation, IT / Software / Systems , Newark, California
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