Position Summary

Quality Systems Lead - Consultant 

Job Description

About ConvergeHEALTH

ConvergeHEALTH is Deloitte Consulting’s healthcare innovation and technology products business.  ConvergeHEALTH supports the information-based transformation of healthcare by enabling healthcare and life sciences organizations to answer the “hard questions” in healthcare–what 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 forward looking Regulatory Compliance

Against an increasingly complex regulatory landscape, we build software products that meet the requirements and will be part of FDA regulated systems, including Software as a Medical Device. We do this by leveraging our deep knowledge of industry regulations and proven methodologies to design, assess, and transform their processes.

The work you’ll perform:

The Quality Systems Lead will be a key member of the ConvergeHEALTH team. As a Quality Systems Lead at ConvergeHEALTH at Deloitte, you’ll have the opportunity to not only lead our products business through changing regulatory and compliance environment and help recommend and implement solutions with our ConvergeHEALTH Quality and Regulatory Affairs (QARA) team.  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 products for their needs.  Key roles and responsibilities include:

  • Guide the evolution of the ConvergeHEALTH QMS through the changing global regulatory environment and provide roadmap to ConvergeHEALTH product teams to meet the needs of the future regulatory landscape
  • Ensure documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies.
  • Works with fellow Quality and Regulatory Affairs (QARA) 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.
  • 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
  • Work with QARA team and clients to advance the ConvergeHEALTH QMS for internal and external 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
  • 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, HITRUST and 510(k)/CE Submission Process
  • Industry sub segment experience (e.g., pharmaceutical, medical device, biotechnology) and 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)
  • Experience in planning, selecting and implementing e-QMS systems preferred
  • 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 25%

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. Learn more about our commitment to developing our people.


As used in this posting, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. 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.

Requisition code: 45307

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