Patients, customers, and regulators are all more demanding than ever. At the same time, life sciences businesses need more than patented drugs to keep themselves profitable. We’re experts in biotech, pharma, healthcare, and medical technologies, and we help clients around the world to tackle these challenges and more.

We work with businesses from discovery and research to marketing and sales. It could be demonstrating the benefits of drug treatments or developing new services to support them. Or it could be keeping businesses competitive and compliant with the right IT to research breakthrough drugs and keep data secure.

Our technology expertise helps clients harness data to understand diseases, run better clinical trials and develop treatments more efficiently. And by understanding the life sciences sector we help business pinpoint the parts of their operation that can bring the most value.

We help clients to:

• Speed up the journey from lab to market
• Simplify business structures to keep costs down and stay compliant
• Turn capabilities into commercial propositions
• Transform the business model to capitalise on their strengths
• Form new partnerships to make the most of discoveries.

Overall a Consultant has responsibility for the following:

• Assist with helping to Identify potential quality issues at clients and business development targets, provide insights into the trends and expectations of regulatory agencies, deliver guidance on developing effective assessment and remediation frameworks and/or practices
• Assist with strategy execution and implementation efforts of Quality Management Systems-related client engagements, including these focus areas - client engagement delivery (i.e. remediating warning letters, consent decrees, development & execution of effective, efficient and sustainable quality management systems); regulatory agency interactions
• Develop and maintain relationships with executives at key clients, identify opportunities, develop proposals and contribute to the development of the pricing strategies
• Be part of fast paced client engagements across multiple functional domains for on-time and quality delivery of work products; Accountable for overall engagement planning, budgeting, staffing, financial management, deliverables, management of the engagement team members

Qualifications

• A minimum of 3  years of experience in the area of Quality Management Systems and/or Regulatory within the Medical Device Industry; prior relevant experience with any global consulting companies serving Life Sciences industry is preferred
• Bachelor's degree in a scientific or engineering discipline from an accredited college or university; MBA is preferred
• Demonstrated knowledge with identifying and remediating pharmaceutical, biotech, medical device and diagnostic businesses with potential quality issues
• Experience in strategy execution and implementation efforts of Quality Management Systems-related initiatives, including but not limited to remediating warning letters, consent decrees, and development and execution of effective, efficient and sustainable quality management systems
• Prior knowledge and subject matter specialty in standard industry practices with Quality Management Systems relating to practices involving Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPP), and/or Good Laboratory Practices (GLP)
• Experience with leading QMS platforms such as Trackwise, MasterControl, ETQ, Pilgrim, and Veeva Vault QMS