HireDiversity

Piscataway, NJ, US

Senior Analyst, Quality & Compliance-8190130110

Description

Johnson & Johnson Health Care Systems, a member of the Johnson & Johnson family of companies, is seeking a Senior Analyst, Quality & Compliance. This position is located in Piscataway, NJ.

Johnson & Johnson Health Care Systems Inc. provides account management and customer support services to key health care customers, including hospital systems and group purchasing organizations, leading health plans, pharmacy benefit managers, and government health care institutions. The company also provides contract management, logistics and supply chain functions for the major Johnson & Johnson franchises.

The Senior Analyst, Quality & Compliance will be responsible to serve as a liaison to associates in the areas of Computer System Validation (CSV) and the tools needed to support the validation of systems at JJHCS. Will ensure the solutions are maintained in a compliant state.

Principal duties and specific responsibilities will include;

Drive understanding and adoption of Quality and Compliance standards. Ensure Quality & Compliance requirements are considered in any initiative or major change request. Responsible for managing small to medium size projects or components of larger projects. Ensure the Tracematrix is updated and kept current with all applicable changes. Work with IT and business teams within JJHCS to maintain Quality systems. Ensure all deliverables are standard and meet the Quality Systems requirements. Execute change control review. Provide training to JJHCS on tools and processes. Create metrics and dashboards for Q&C activities like Change Control and SDLC activities. Act as liaison to other Business teams. Participate in the review and approvals of validation documentation produced by other project members and programs supporting system development at JJHCS. Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies and to ensure systems to be developed adhere to corporate SDLC methodology.

Coaching new team members on creation and execution of CSV requirements and documents, while ensuring adherence to the SDLC. Participates in day-to-day risk management activities to meet regulatory, security and business requirements. Develops knowledge on regulatory, compliance and security trends and best practices. Maintain sector alignment on the Compliance strategy and overall quality system approach. Provides quality support to the Q&C Manager/Director. Aligns the development methodology with Compliance plans, policies and procedures. Supports the coordination, delivery of information and response to audit observations for internal and external audits. Prepares regular and ad hoc reports or metrics on risk management performance to be communicated to both IT and J&J management. Effectively participate in ongoing change control process (interface to IT support, impact analysis, release mgt, data changes, testing etc.) Ensure systems remain compliant to regulations and internal policies as business requirements change. Build strong relationships with system business owners.

Qualifications


A minimum of a Bachelor's degree is required. A minimum of 3 years of CSV and/or Q&C experience is required. Knowledge of System Development Life Cycle (SDLC) Processes & Methodologies is required, GAMP 5 experience preferred. Experience in writing and executing documentation for all aspects of the validation deliverables, Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/validation reports is required. Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specifications is required. Knowledge of Change Control Methodologies and Technology is required. Ability to use data to influence leadership, peers and other team members on processes and projects is required.

Experience with various FDA standards (21 CFR Part 11, 210, 211, 820) is preferred. Knowledge on SAP Solution Manager (ChARM) is preferred. Hands-on experience with HP Quality Center is preferred. Knowledge of creating and maintaining dashboards/metrics is preferred. Ability to analyze data and make recommendations based on findings is preferred. Experience working remotely with business partners in a global environment is preferred.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Piscataway
Organization: Johnson & Johnson HCS Inc. (6077)