POSITION SUMMARY
The 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 continuous improvement.
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 process
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 System/Process Owners.
Provides training for the CSV program to new System/Process Owners.
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 assigned
MINIMUM QUALIFICATIONS
Minimum 5-7 years in GXP computer system validation experience
7 + Biotech/pharmaceutical/GXP industry preferably in Quality
Working knowledge of GxP regulations and CSV/CSA principles, including, but not limited to 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.
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 Smartsheet.
Veeva experience is a plus.
Familiarity with ERP and Clinical Data Management systems a plus.
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, LICENSES, REGISTRATIONS
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 $135,000 - $155,000.
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.
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