Change manager Jobs in Berkeley, CA

QA Manager

This role oversees, supports, and administers Computer System Validation (CSV) and Data Integrity activities to ensure effective and efficient process maintenance for GxP functions. The QA Manager analyzes user enhancement requests, designs and implements process and system improvements, and ensures that quality management systems remain compliant, efficient, and aligned with business goals. The position focuses on supporting end users, business owners, and system owners, while managing quality-related changes, deviations, and CAPAs, and driving continuous system and process improvements.

Responsibilities:

• Analyze user enhancement requests to design and deliver solutions that improve business processes, enhance system efficiency, close process gaps, and enable automation.
• Assemble and document user and functional requirements to support new or updated system capabilities.
• Author and execute implementation plans, develop solutions, and manage project timelines to ensure timely and successful execution.
• Perform User Acceptance Testing (UAT), Performance Qualification (PQ), and validation testing to confirm systems operate in a validated and compliant state.
• Create and run reports, track follow-up actions, and ensure data quality and compliance with applicable standards and procedures.
• Generate metrics and dashboards to support business goals and provide visibility into system and process performance.
• Proactively improve system monitoring, identify and eliminate user issues, and deliver better value to cross-functional teams.
• Drive CSV and Data Integrity (DI) activities and Quality Management System (QMS) results, ensuring timeliness and compliance across QA, system owners, business owners, and cross-functional project forums.
• Escalate issues, risks, and non-conformances in a timely and effective manner.
• Manage day-to-day business system administration, including system access, user accounts, and permissions.
• Perform QMS activities such as managing changes, deviations, tracking actions, and supporting CAPAs related to systems and processes.
• Design system solutions and manage configuration in line with business and regulatory requirements.
• Work proactively with users to resolve issues, clarify requirements, and drive adherence to project timelines.
• Create reports based on defined requirements and maintain ongoing reporting to support operational and quality needs.
• Maintain system documentation and associated records in accordance with CSV and QMS requirements.
• Create and run reports, track follow-up actions, and ensure data quality and compliance across systems and processes.
• Review and approve validation deliverables, including URS, FS, IQ, OQ, PQ, and related lifecycle documents.
• Identify, mitigate, escalate, and resolve issues and risks related to systems, validation, and data integrity.
• Author and review CSV and DI records and QMS records, including policies, procedures, and lifecycle documents, as applicable.
• Generate metrics to support business goals and provide insight into system performance and compliance status.
• Maintain end-user support information, FAQs, and other support materials to assist users in effectively operating systems.
• Revise business guidance and user reference documentation to reflect system changes, process updates, and best practices.
• Support internal and external audits and inspections by providing documentation, evidence, and explanations related to CSV, DI, and QMS activities.
• Support the CSV and DI program by contributing to strategy, execution, and continuous improvement initiatives.
• Collaborate with cross-functional project teams, technical communities, and users to deliver customer-oriented technology solutions.
• Drive process excellence by applying strong process improvement and negotiation skills to optimize workflows and system usage.

Essential Skills:

• Bachelor's degree in science or a related field and a minimum of 7 years of related experience, or an equivalent combination of education and experience.
• At least 5 years of experience working with validated applications in a pharmaceutical or other regulated environment.
• Direct, hands-on experience implementing GxP computerized systems and maintaining them in a validated state.
• Experience and knowledge of quality and regulatory business processes in a regulated environment.
• Demonstrated oversight, support, and administration of Computer System Validation (CSV) and Data Integrity programs.
• Proven ability to manage accounts, evaluate and manage CSV/DI-related changes, deviations, and CAPAs, and support QMS activities.
• Knowledge of system administration for Veeva Platform (Quality QMS, Quality QDocs) and other SaaS-based regulated applications.
• Experience with other regulated applications such as Learning Management Systems and QMS tools.
• Knowledge of databases and computer networking concepts relevant to regulated systems.
• Proven business and technology skills with a track record of delivering customer-oriented technology solutions.
• Strong process improvement skills with the ability to drive process excellence and negotiate effectively with stakeholders.
• Excellent communication skills, including oral, written, and presentation abilities, with the capacity to communicate in both technical and user-friendly language.
• Experience collaborating with cross-functional project groups, technical communities, and end users to achieve results and meet timelines.
• Demonstrated ability to act as a collaborative team player focused on results, timeliness, and compliance.

Additional Skills & Qualifications:

• Experience supporting end users, business owners, system owners, and QA in a GxP environment.
• Familiarity with SaaS-based quality and regulatory systems, particularly on the Veeva platform.
• Experience generating and interpreting metrics and reports to support business and quality objectives.
• Background in supporting internal and external audits and inspections related to CSV, DI, and QMS.
• Ability to develop, revise, and maintain business guidance, user reference documentation, and end-user support materials.
• Comfort working in cross-functional project forums and contributing to continuous system improvement initiatives.
• Strong organizational skills with the ability to manage multiple tasks, timelines, and priorities in a regulated environment.

Work Environment:

This position is based onsite Monday through Friday in Alameda. The role operates within a regulated, GxP-focused environment that relies on validated, SaaS-based quality systems, including the Veeva platform for Quality QMS and Quality QDocs, as well as other regulated applications such as Learning Management Systems and QMS tools. You will work closely with cross-functional teams, business owners, system owners, QA, and end users in a collaborative, process-driven setting. The environment emphasizes compliance, documentation, and continuous improvement, with regular interaction with audits and inspections and a strong focus on maintaining validated systems and robust data integrity.

Job Type & Location:

This is a Contract position based out of Alameda, CA.

Pay and Benefits:

The pay range for this position is $50.00 - $70.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully onsite position in Alameda, CA.

Application Deadline:

This position is anticipated to close on Oct 5, 2026.