Compliance QA Manager - Systems

The Compliance QA Manager - Systems is responsible for the oversight, support, and administration of client's Quality Management Systems (QMS) to ensure these are effective and efficient, and maintained to support GxP functions. Supports end users and QA requirements, account management, and evaluates changes for implementation and continuous improvement initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
As QA Core, supports QA Partner:
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
Maintain system documentation
Create and run reports; track follow-up actions to ensure data quality and compliance
Reviews and approves validation deliverables (URS, FS, IQ/OQ/PQ, etc.)
Identifies, mitigates, escalates, and resolves issues and risks
Authors and review CSV, DI policies, procedures, lifecycle documents
Help generate metrics to support business goals
Maintain end-user support information
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 Leaning Management System, ComplianceWire, if applicable

SUPERVISORY RESPONSIBILITIES:
None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
Bachelor's degree in science or related field and a minimum of 7 years of related experience; or,
Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:
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.
Collaborative working approach.

Knowledge/Skills:
General knowledge of System Administration with the Veeva Platform (Quality QMS, Quality QDocs)
Working knowledge/experience with Other Regulated Applications, such as Learning Management Systems and Quality Management Systems.
General knowledge of database and computer networking
Working knowledge/experience with SaaS systems

WORKING CONDITIONS:
Environment: primarily working indoors, performing office work.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.