Deloitte Senior Validation Consultant in Chicago, Illinois
Ready for an exciting and fast-paced career? Have a passion for turning challenges and opportunities into long-term competitive advantages? As a Regulatory and Compliance Senior Consultant at Deloitte, you ll have the opportunity to not only assist in identifying issues in organizations adapting to a changing regulatory environment but help implement solutions while gaining hands-on experience working alongside leading professionals in financial services. You will have the opportunity to build your professional skills in a variety of project experiences and be involved in helping our clients understand, analyze, and respond to various business opportunities and challenges presented by the changing regulatory marketplace.
Work you ll do
Experience in Life Sciences Industry, functional knowledge of Pharmaceuticals, Biologics, Medical Devices & Diagnostics and FDA regulations, knowledge of analytics and reporting tools, strong communication skills, proficiency in MS Office suite. The description of this position is:
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.
REGULATORY & COMPLIANCE
Against an increasingly complex regulatory landscape, we help clients mitigate risk and achieve compliance. We do this by leveraging our deep knowledge of industry regulations and proven methodologies to design, assess, and transform their processes. We work with our clients to effectively navigate a regulatory investigation or inquiry, achieving the overall risk profile they need to power their organization forward. Learn more about Deloitte Advisory s Regulatory and Compliance practice. at http://www2.deloitte.com/us/en/pages/advisory/solutions/regulatory-and-compliance-solutions.html
The key job responsibilities include the following:
Firm understanding and practical experience with FDA cGxP regulations and some of the following: EMEA, HC, ICH, 21 CFR Part 820, 21 CFR Part 11, PIC/S, ISO, MHLW, MHRA, PDMA, and 510(k) Submission Process
Demonstrate ability to analyze problems, develop solutions, and communicate results
Complex problem-solving abilities across operational, organizational, and strategic matters
Strong communication (both written and verbal English), and organizational and interpersonal relationship-building skills
The key skills required are as follows:
Industry sub segment experience (e.g., pharmaceutical, medical device, biotechnology) in the areas of manufacturing, quality assurance/quality control or regulatory compliance
Operational area (e.g., R&D/clinical, operations/manufacturing, quality assurance/control, IT, supply chain, commercial)
Process knowledge and experience (e.g., drug safety/pharmacovigilance, product life cycle management, computerized system validation, manufacturing execution, quality systems, IT quality systems, aggregate spend, records management)
Functional or technical computer system knowledge and experience (e.g., EDMS, EQMS, SAP, Oracle, LIMS,
Documentum, MES, PLM)
Specific quality business process knowledge and experience (e.g., adverse event reporting, change control, document management, CAPA, product testing, GMO auditing, risk assessments)
How you ll grow
At Deloitte, our professional development plan focuses on helping people at every level of their career to identify and use their strengths to do their best work every day. From entry-level employees to senior leaders, we believe there s always room to learn. We offer opportunities to help sharpen skills in addition to hands-on experience in the global, fast-changing business world. From on-the-job learning experiences to formal development programs at Deloitte University, our professionals have a variety of opportunities to continue to grow throughout their career. Explore Deloitte University, The Leadership Center. at https://zoomforth.com/s/deloitte/du#home
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. at http://www2.deloitte.com/us/en/pages/careers/articles/life-at-deloitte-benefits-and-rewards.html
Deloitte s culture
Our positive and supportive culture encourages our people to do their best work every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer well-being programs and are continuously looking for new ways to maintain a culture where our people excel and lead healthy, happy lives. Learn more about Life at Deloitte.
Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships with our clients, our people and our communities. We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte s impact on the world. at http://www2.deloitte.com/us/en/pages/about-deloitte/articles/deloitte-corporate-citizenship.html
We want job seekers exploring opportunities at Deloitte to feel prepared and confident. To help you with your interview, we suggest that you do your research: know some background about the organization and the business area you re applying to. Check out recruiting tips from Deloitte professionals. at http://www2.deloitte.com/us/en/pages/careers/topics/recruiting-tips.html
Category: Risk Management
As used in this document, Deloitte means Deloitte LLP and its subsidiaries. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. 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.