Mark Carroll

About Mark Carroll

Quality, regulatory, and compliance executive with 20+ years’ experience in management across multiple industries including medical devices and pharmaceutical manufacturing facilities producing API, finished dosage forms (including parenterals), and biopharmaceuticals. Adept at balancing quality, regulatory, technical, and business needs. Knowledgeable of regulatory, compliance, quality system development, and auditing techniques. Proven abilities managing staff and interacting with clients at multiple locations while maintaining a focus on business priorities. Experience in both large and small (virtual) companies.Highlights- Key company liaison for regulatory authorities and third parties- 20 years of managing personnel in different settings (Laboratory, Manufacturing, and Clinical) including both small and large staffs in resource limited environments- Strong verbal and written communication skills - 24 years’ experience in auditing quality systems in several areas including medical device, ISO GCP, GLP, and GMP, and hosting external client and regulatory authority audits- Developed and implemented quality systems across multiple sites for clients in the pharmaceutical and medical device industries (includes quality manuals, procedures, work instructions, forms, templates, checklists, etc…)- Adept at designing workflows for and implementing computerized systems for managing systems, including change control, CAPA, Complaints, Vendor Assessment, Management Review, Nonconforming Product, etc- Managed the regulatory submission process (IND, NDA, PMA, 510(k), Annual Reports, etc.) and developed regulatory strategy for multiple projects- Extensive experience with drafting responses to regulatory authorities, including but not limited to; Day 74 letters, mid-cycle review letters, 483 responses, and warning letter responses- Consent Decree experience- Adept at presenting quality and regulatory information to both private and public company Boards of Directors

Experience

1. VP, Head of Quality and Compliance

   Bioxcel Therapeutics, Inc

   Mar 2019 — Present

   Responsible for all quality and corporate compliance activities.

Education

• New York University - Polytechnic School of Engineering

  Master of Science (MS), Management of Technology

  1995 — 1997

• Stockton University

  Bachelor's degree, Chemistry

  1987 — 1993

Skills

• Validation
• Quality Assurance
• Glp
• Gcp
• Biopharmaceuticals
• Iso 13485
• Gmp
• Process Improvement
• Quality System
• Gxp
• Medical Devices
• Capa
• Iso 9000
• Regulatory Affairs
• Pharmaceutical Industry
• Sop
• Fda
• Change Control