Deloitte Life Sciences Manager - Product Quality and Risk Management (Regulatory & Compliance) in San Francisco, California
Deloitte is one of the leading professional services organizations in the United States, specializing in audit, tax, consulting and financial advisory services with clients in more than 20 industries. We provide powerful business solutions to some of the world s most well-known and respected companies, including more than 75 percent of the Fortune 100.At Deloitte, you can have a rewarding career on every level. In addition to challenging and meaningful work, you ll have the chance to give back to your community, make a positive impact on the environment, participate in a range of diversity and inclusion initiatives, and find the support, coaching, and training it takes to advance your career. Our commitment to individual choice lets you customize aspects of your career path, your educational opportunities and your benefits. And our culture of innovation means your ideas on how to improve our business and your clients will be heard.
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 clientsmitigate 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.
Bachelors degree in related field.
Experience with IT Systems lifecycle (development, testing, implementation) Quality assurance domain preferred.
Process improvements as well as quality and regulatory compliance of GxP processes.
Experience with key compliance processes, such as: GxP, GAMP, CSV, IQ/OQ/PQ, and 21 CFR part 11 and 820.
Led IT projects, from developing requirements, through design development, implementation and validation.
CSV skills (can be IT QC skills, but also could be CSV skills in the context of delivering regulated system implementations
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
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 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.
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.
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Category: Risk Management