Deloitte Deloitte Platforms, ConvergeHEALTH Quality Management System (QMS) Manager in New York, New York

Deloitte Platforms, ConvergeHEALTH Quality Management System (QMS) Manager

Job Location: Boston, New York, or North-East Corridor

About Deloitte Consulting s Platforms Practice

Deloitte Consulting s Platforms practice is an organization within Deloitte Consulting whose goal is to build an environment and culture of continuous innovation to drive profitable revenue through the identification and incubation of breakthrough ideas in IP-based businesses and markets. The practice focuses on prototyping, developing, deploying and maintaining a product portfolio that spans multiple software technologies including wearables, machine learning, advanced analytics, social/mobile, and more. Our team is responsible for designing and developing innovative products that not only augment our leading services practice, but strike at the heart of our clients' business needs.

ConvergeHEALTH is a part of Deloitte Consulting s Innovation practice. ConvergeHEALTH supports the information-based transformation of healthcare by enabling healthcare and life sciences organizations to answer the hard questions in healthcarewhat works, for whom, why, in what context, and at what cost? ConvergeHEALTH brings powerful analytics platforms, data models, advanced analytics and significant experience from Deloitte Consulting LLP s Life Sciences and Healthcare practice to help our clients survive and thrive in the new paradigm of value-based, personalized medicine. Our mission is to enable a learning healthcare system where each encounter with the healthcare system becomes a learning event that will lead to greater efficiency, higher quality care and sustained innovation, to the benefit of improving patient outcomes.

Are you looking for an organization with startup spirit or enterprise strength? Now you can have both! We are looking for talented individuals with an innovative mindset and technical skillset to join our growing team.

Quality Management System for Regulatory compliance with ConvergeHEALTH

Against an increasingly complex regulatory landscape, we build software products that meet the requirements and will be part of client regulated systems and SaMDs. We do this by leveraging our deep knowledge of industry regulations and proven methodologies to design, assess, and transform their processes. Wherever required, clients maybe leveraging ConvergeHEALTH QMS for their internal needs to supplement their quality efforts.

The work you ll perform:

The Quality Management System (QMS) Manger will be a key member of the ConvergeHEALTH practice within Deloitte Consulting. As a QMS Manager at ConvergeHEALTH at Deloitte, you ll have the opportunity to not only lead the changes in ConvergeHEALTH Quality Management System (QMS) adapting to a changing regulatory and compliance environment but help implement solutions while gaining hands-on experience working alongside ConvergeHEALTH product engineering teams to build the software products that meet the needs for regulated systems and Software as a Medical Devices (SaMDs). You will have the opportunity to build your professional skills in a variety of project experiences and be involved in helping our clients understand, assess, and leverage ConvergeHEALTH QMS for their needs for regulated systems and SaMD.

  • 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.

  • Support client assessments of ConvergeHEALTH QMS as it pertains to requirements for development of regulated systems and SaMDs

  • Work with clients to setup the ConvergeHEALTH QMS for their internal use to supplement existing quality systems

Skills and qualifications:

  • 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.

  • 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, ISO 13485, IEC 62304 and 510(k) Submission Process

  • 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)

  • 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

  • Must have high energy and flexibility to work effectively in a fast-paced environment; team player; positive attitude

  • Ability to work independently and under general direction with a strong sense of motivation to succeed.

  • Travel up to 50%

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

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 at https://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 nourish and build a culture where our people excel and lead healthy, happy lives. Learn more about Life at Deloitte.

Corporate Citizenship

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 https://www2.deloitte.com/us/en/pages/about-deloitte/articles/deloitte-corporate-citizenship.html

Recruiter Tips

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Category: Management Consulting

About Deloitte

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.