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

You'll be working with McKinsey's Operations practice in Chicago, New Jersey (Summit) or New York. Our Operations practice assists our clients in solving complex operational challenges. 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.

Our Quality, Control & Remediation service line 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.

What You'll Do

As an Expert, you will play a key role on McKinsey consulting teams, 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 apply 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.

You 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.


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