Actalent
Compliance QA Manager
Actalent, Alameda, California, United States, 94501
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 Skills
Analyze user enhancement requests
Gather and document user and functional requirements
Author and execute implementation plans
Perform User Acceptance Testing (UAT)
Perform Performance Qualification (PQ) and Validation testing
Manage system access and permissions
Perform change management activities
Design solutions and manage configuration
Create and run reports
Support activities related to internal and external audits/inspections
Support activities related to Computer System Validation and Data Integrity program
Oversee and maintain the Integration tool with the Learning Management System, ComplianceWire
Experience
At 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-solving
Attention to detail
Communication
Project management
Continuous improvement mindset
Customer 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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 Skills
Analyze user enhancement requests
Gather and document user and functional requirements
Author and execute implementation plans
Perform User Acceptance Testing (UAT)
Perform Performance Qualification (PQ) and Validation testing
Manage system access and permissions
Perform change management activities
Design solutions and manage configuration
Create and run reports
Support activities related to internal and external audits/inspections
Support activities related to Computer System Validation and Data Integrity program
Oversee and maintain the Integration tool with the Learning Management System, ComplianceWire
Experience
At 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-solving
Attention to detail
Communication
Project management
Continuous improvement mindset
Customer 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.