Project Associate-Regulatory and Legal Support-Corporate Compliance & Operational Risk

Position Summary

Description

We help clients align their people, process, and technologies with business objectives, and to improve and transform their operations and operational risk programs in a strategic and efficient way. In doing so, organizations can focus on what is important, anticipate risk, and enhance their overall operations to support their strategic objectives and bolster their risk preparedness. We are currently looking for Project Associates to performinga variety of IT Quality. This is a 1-2 year assignment located in New Jersey.

Key Responsibilities:

• Ensures documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies.
• Review functional or technical requirement documents and develop test cases to the stated requirements including positive and negative testing.
• Review the accuracy and completeness of software validation deliverables created by other process teams (e.g., Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)
• Create Traceability Matrices linking approved requirements to test cases in HPQC (both automated and manual).
• Works with fellow validation and project team members in a dynamic environment with shuffling priorities and responsibilities.
• Provide expertise in the review of all deliverables across the project lifecycle, ranging from requirements documentation to final protocol reports.
• Keeps the validation lead informed of any issues regarding the quality of the deliverables, or any potential sources of impact to the project timeline.
• Accurately report the status of assigned deliverables and support other compliance work as necessary

Qualifications

Required:

• Experience with IT Systems lifecycle (development, testing, implementation) Quality assurance domain preferred
• Knowledge of software testing
• Exposure to cross functional teams (lead, co-ordination)
• Ability to deal with all employees and external business contacts while conveying a positive, service oriented attitude
• Attention to detail, quality, time management and customer focus
• Interpersonal and ability to operate effectively in a matrix environment
• Ability to write, read, and understand business as well as technical requirements
• Experience with MS Office applications including: Word, Excel, PowerPoint
• Travel up to 80% (While 80% of travel is a requirement of the role, due to COVID-19, non-essential travel has been suspended until further notice)
• Limited immigration sponsorship may be available

Preferred:

• At least 3 years of computer system validation in a pharmaceutical/medical devices environment
• Experience in the validation of software tools in a FDA regulated environment.(e.g., SAP, SAP Solution Manager, and HPQC.)
• Knowledge of regulations and software lifecycle approaches 21 CFR Part 11 and ,QSR's, ISO 13485, 21 CFR part 11,820,807,803 GAMP, SDLC methodologies)
• Experiencein development of Validation Master Plans for simple systems or facilities.
• Experiencein Project execution within at least one area of systems validation e.g., laboratory equipment, facilities, utilities, manufacturing equipment, metrology equipment, information systems.

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Benefits

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.

Our people and culture

Our diverse, equitable, and inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our client most complex challenges. This makes Deloitte one of the most rewarding places to work. Learn more about our inclusive culture.

Professional development

From entry-level employees to senior leaders, we believe there's always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

As used in this posting, "Deloitte Advisory" means Deloitte & Touche LLP, which provides audit and enterprise risk services; Deloitte Financial Advisory Services LLP, which provides forensic, dispute, and other consulting services; and its affiliate, Deloitte Transactions and Business Analytics LLP, which provides a wide range of advisory and analytics services. Deloitte Transactions and Business Analytics LLP is not a certified public accounting firm. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. These entities are separate subsidiaries of Deloitte LLP.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

Deloitte will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws. See notices of various ban-the-box laws where available.

Requisition code: 10099