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Operations – FDA Remediation & Quality Expert Pharma/Med Devices – North America



McKinsey & Company is a management consulting firm that helps leading corporations and organizations make distinctive, lasting and substantial improvements in their performance. With consultants deployed from more than 90 offices in more than 50 countries, McKinsey advises companies on strategic, operational, organizational and technological issues. 
Detailed Description
About the Quality, Control & Remediation Practice:
McKinsey’s Quality, Control & Remediation Practice aspires to transform our pharma and med device industry clients into the benchmark of high quality in order to save patient lives, avoid supply chain disruption, and enable operations excellence – at optimal cost to our clients. 
Roles / Responsibilities:
McKinsey & Company is looking for an Expert with deep experience and relationships at the FDA and/or other notified bodies, who has hands-on experience conducting and leading large scale inspections; depth within the risk and regulatory space; and proven skills in managing FDA inspections, from the view of the FDA. This individual will help build McKinsey’s Compliance capabilities, while also leading clients to understand and address their quality and compliance challenges through the application of regulatory and/or technical expertise. In addition, this role will delivery long term, transformative risk and regulatory solutions for clients in the Operations and Pharmaceutical/Medical Products space, providing distinctive client impact on CEO-level issues.
Experts play a key role in McKinsey consulting teams, often working with multiple project teams across a dynamic set of situations in a way that leverages their deep knowledge in a specific area. They apply a broad range of creative problem-solving skills, combining deep technical and analytical excellence to help solve their piece of the overall client puzzle. They push both their coworkers and our clients in thinking about challenging situations in new and transformative ways.
In addition, McKinsey’s Experts work with senior leaders, identifying gaps and opportunities to apply frameworks that substantially improve performance in key areas. They integrate at multiple points in a style, leading workshops to help build a change story or vision, often leading longer term engagements with teams, such as setting the agenda, synthesizing output and assisting in carrying out the study. In addition, they develop short and long-term plans for all relevant levels of client leadership, with anticipated deliverables, outcomes, and required resources to sustain the transformation
This is an excellent opportunity to apply your expertise across industries in a new setting with a constructive relationship with industry clients and have a significant positive impact both for our clients and the broader community of stakeholders (patients, caregivers, etc.).
  • Minimum of 5 years of experience within medical device quality assurance and regulatory compliance, working for the Food and Drug Administration (FDA)/Office of Regulatory Affairs (ORA)
  • The ideal candidate will have held a title such as Compliance Officer, Pharmaceutical Inspectorate or Level II Certified Medical Device Investigator
  • Has managed multiple inspections of large pharmaceutical or medical device manufacturing facilities
  • Global experience, having cooperated with pharmaceutical or medical device inspections in other countries
  • Have knowledge of, and relationships with, investigators and leadership within District Offices
  • Know the immediate best steps in responding to a FDA 483 or Warning Letter
  • Knowledge of the pharmaceutical regulations (21CFR, Eudralex, etc.)
  • Certified Quality Auditor or Engineer (CQA, CQE) nice to have
To find out more information about the role and to apply, please click here

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