Compliance Quality Assurance Manager

2 days ago

Fremont, California, United States Actalent Full time
Job Title: Quality Assurance Manager

Actalent is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our clients' business processes and systems.

Key Responsibilities:
  • Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization.
  • Gather and document user and functional requirements.
  • Participate in the authoring and execution of implementation plans, development of solutions, and manage project/change timelines.
  • Perform User Acceptance Testing (UAT), Performance Qualification (PQ), and Validation testing, if applicable.
  • Day to day business system administration: manage system access and permissions, perform change management activities, design solutions and manage configuration, liaise with users to resolve issues, create reports based on defined requirements, and maintain system documentation.
  • Track follow-up actions to ensure data quality and compliance.
  • Help generate metrics to support business goals.
  • Manage updates to business guidance and user reference documentation.
  • Continuously look for ways to improve monitoring, user issues, and deliver better value to the customer.
  • 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, if applicable.

Requirements:

  • Validated applications in a pharmaceutical or regulated environment
  • Quality and regulatory business processes
  • Process improvement skills
  • Veeva Platform (Quality QMS, Quality QDocs)
  • Ability to communicate ideas in both technical and user-friendly language

About Actalent:

Actalent is a leading provider of specialized experts who drive scale, innovation, and speed to market for visionary companies. With a network of almost 30,000 consultants and more than 4,500 clients across the U.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. Building a culture of care, engagement, and recognition with clear outcomes, ensuring growth opportunities for our people, and being an equal opportunity employer.

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