Expert - Pharma, FDA Remediation & Quality

Qualifications

  • Advanced degree or or MBA
  • Minimum 5 years of experience within pharmaceutical quality assurance and regulatory compliance, working for the Food and Drug Administration (FDA)/Office of Regulatory Affairs (ORA)
  • 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
  • Demonstrated aptitude for analytics
  • Ability to work collaboratively in a team environment
  • Ability to work effectively with people at all levels in an organization
  • Skills to communicate complex ideas effectively
  • Willingness to travel up to 80%

Who You'll Work With

At McKinsey, you can build a career out of making things happen! You'll be working with McKinsey's Quality, Compliance, & Remediation practice. Our Quality, Compliance, & Remediation practice assists our clients in solving the world's toughest problems. Blending strategic thinking with hands-on practicality, our teams of consultants and experts work to develop and implement operational strategies that solve our clients' most critical problems on a global scale.

What You'll Do

You will work in teams to collaborate as Experts, often working with multiple project teams across a dynamic set of situations in a way that leverages your deep knowledge in a specific area.

You will make a meaningful, hands-on contribution by applying a broad range of creative problem-solving skills, combining deep technical and analytical excellence to help solve your piece of the overall client puzzle. In addition, you will work with senior leaders, identifying gaps and opportunities to apply frameworks that substantially improve performance in key areas.

In this exciting collaborative culture, you will integrate with other teams at multiple points in a project, 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, you will likely develop short and long-term plans for all relevant levels of client leadership, with anticipated deliverables, outcomes, and required resources to sustain the transformation.


See Inside the Office of McKinsey

McKinsey helps clients facing a whole range of business questions to identify, understand, and analyze their options and make good strategic decisions. Whether it’s a tech giant contemplating a large investment, a pharma company expanding overseas, or a nonprofit looking to increase donations, the McKinsey team knows the ins and outs of the industries it serves and helps its clients tackle tough challenges and make big decisions.


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