Contact: Dinesh for Salary information and Employer name.
Location: Vericel - Cambridge, MA
Essential Functions:
• Direct involvement in day to day operations – including FMEA facilitation, Cross Functional Change management Meetings, department streamlining/improvements, site procedure education
• Facilitate/Lead external regulatory inspections
• Motivate and inspire a quality compliance culture across the organization
• Build effective and sustainable cross functional relationships
• Drive an environment of teamwork and open communication
• Establish key performance indicators for department
• Accountable for project completions and achievement of such goals
• Building collaborative cross-functional relationships
Required Education and Experience:
• Bachelor’s degree or equivalent and 5+ years of experience in a biotech, pharmaceutical, or similarly regulated industry
• 1+ years of leadership experience directly related to Quality Management A strong understanding of regulatory requirements affecting Biologics and Medical Devices
• Strong leadership and personnel development experience
• Proven Risk Management/FMEA experience/knowledge
Preferred Education and Experience:
• Previous Quality leadership experience in an organization involved with medical device/biologics
• A strong understanding of Medical Device and Biologics FDA regulations
• 5+ years of leadership experience directly related to Quality Management
Location: Vericel - Cambridge, MA
Essential Functions:
• Direct involvement in day to day operations – including FMEA facilitation, Cross Functional Change management Meetings, department streamlining/improvements, site procedure education
• Facilitate/Lead external regulatory inspections
• Motivate and inspire a quality compliance culture across the organization
• Build effective and sustainable cross functional relationships
• Drive an environment of teamwork and open communication
• Establish key performance indicators for department
• Accountable for project completions and achievement of such goals
• Building collaborative cross-functional relationships
Required Education and Experience:
• Bachelor’s degree or equivalent and 5+ years of experience in a biotech, pharmaceutical, or similarly regulated industry
• 1+ years of leadership experience directly related to Quality Management A strong understanding of regulatory requirements affecting Biologics and Medical Devices
• Strong leadership and personnel development experience
• Proven Risk Management/FMEA experience/knowledge
Preferred Education and Experience:
• Previous Quality leadership experience in an organization involved with medical device/biologics
• A strong understanding of Medical Device and Biologics FDA regulations
• 5+ years of leadership experience directly related to Quality Management
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