Specialist - Quality Compliance & Remediation

Qualifications

  • Bachelor's degree
  • Graduate degree and/or a minimum of 2-5 years of experience in a relevant field
  • Experiences as an auditor, quality engineer, compliance analyst, quality assurance specialist, or compliance specialist with a major pharmaceutical organization
  • Experience managing external quality failures, 483s and Warning Letters, and/or managing a product recall
  • Certified Quality Auditor or Engineer (CQA, CQE) nice to have
  • Demonstrated aptitude for analytics
  • Strong knowledge of ISO, FDA, EMA and ICH requirements
  • 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 service line in North America. Our QC&R service line assists our clients in solving the world's toughest problems. Blending strategic thinking with hands-on practicality, our team of consultants and experts work to develop and implement operational strategies that solve our clients' most critical problems on a global scale. We help clients achieve significant and sustainable improvements in their quality performance and customer satisfaction. We design and conduct transformations in a variety of industries, from highly regulated industries, such as pharma and med devices, to advanced manufacturing industries, such as automotive and aerospace.

What You'll Do

You will work in teams to collaborate as experts especially in the areas of engineering, manufacturing, or procurement, helping clients achieve increased performance levels.

You will make a meaningful, hands-on contribution to the analysis, design, and implementation of quality and compliance approaches, developing tailor-made solutions and working closely with clients to ensure positive impact and sustainable results.

In this exciting collaborative culture, not only will you work directly with clients, you will also share your experiences and insights with colleagues globally, thereby expanding our knowledge and refining our approaches in the field of quality and compliance.


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