Seasoned Quality Leader
Valued quality and GXP regulatory compliance leader with 30 years of real-world boots-on-the-ground experience and insights into the complex and global rigors of small and large life science organizations from early-stage discovery through critical development milestones to product approval, launch and beyond.
What differentiates me from most Quality professionals is my approach to integrating quality and regulatory compliance matters proactively, strategically, relationally (collaboratively and not just transactionally) with others and as value into a client’s business plan for achieving predictability, patient needs and business success – anticipating, identifying and resolving potential issues before they become significant organizational pain points with the FDA, investors or other key stakeholders.
Relevant Therapeutic Areas
- Metabolic diseases
- Small & Large Molecules
- Vice President and Head, Quality
- Head, Global R&D GMP Quality Assurance
- Greater Boston Area
- Open to remote, travel, in-office
- Small & Mid-Sized Biotechs
Skills & Accomplishments
- Extensive, results-oriented experience and insight into the complex and global challenges and opportunities of small and large organizations from early stage discovery/development through approval/launch and beyond.
- Champion for proactive, fit-for-purpose, risk-managed and value-added Quality that interfaces science and business and enables public health/patient safety and regulatory compliance – creating a competitive advantage.
- Passionate about collaborative problem solving, risk management and recruiting/mentoring key talent and teams.
- Successful track record of regulatory approvals and inspections as well as building relationships and partnerships with key stakeholders throughout drug development – drawing on experience from LIPITOR® to LINZESS®