Job Description

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

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

Additional Information

All your information will be kept confidential according to EEO guidelines.