Job Title: Compliance QA Manager - Systems

Job Description

The Compliance QA Manager - Systems oversees, supports, and administers the company's Quality Management Systems (QMS) to ensure they are effective, efficient, and maintained to support GxP functions. This role supports end users and QA requirements, account management, and evaluates changes for implementation and continuous improvement initiatives.

Hard SkillsAnalyze user enhancement requestsGather and document user and functional requirementsAuthor and execute implementation plansPerform User Acceptance Testing (UAT)Perform Performance Qualification (PQ) and Validation testingManage system access and permissionsPerform change management activitiesDesign solutions and manage configurationCreate and run reportsSupport activities related to internal and external audits/inspectionsSupport activities related to Computer System Validation and Data Integrity programOversee and maintain the Integration tool with the Learning Management System, ComplianceWireExperienceAt least 5 years of experience working on validated applications in a pharmaceutical or regulated environment.Experience and knowledge of the quality and regulatory business processes.Direct hands-on experience implementing GxP computerized systems and maintaining validated state.Strong process improvement skills and orientation.Must have proven business and technology skills with success providing customer- oriented technology solutions environment.Proven strong communication skills interacting with user and technical communities.Ability to communicate ideas in both technical and user-friendly language.Problem-solvingAttention to detailCommunicationProject managementContinuous improvement mindsetCustomer focus

Work Site

This is a fully on-site position in Alameda, California.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.