Craig Long

About Craig Long

I am an Executive Leader with 30 years of experience in the pharmaceutical industry (parenteral, biopharmaceutical, oral solid dose and medical device/combination product). I am experienced in Quality Assurance/Systems, Compliance, Quality Control, Manufacturing, Inspection/Packaging, Supplier Management, Auditing, Training, Document Control, Incoming Raw Materials and Product Release, Stability, and Validation. I have extensive knowledge of cGXPs (domestic and foreign), ISO, USDA Animal Welfare Act, DEA Controlled Substance, and CDC Select Agent Control. Have a proven track record for developing and implementing various electronic quality systems, closing gaps, support global quality and operation excellence programs. I have successfully represented my areas as well as serving as site host/lead during external agency inspections, internal and CMO audits.General Skills:• Sterile, Aseptic, Oral Solid Dose, Biologics, Drug & Chemical and Medical Device/Combination Products • cGMP, CFR, ICH, ISO, USP, FDA, EU, JP, ANVISA, TGA, CDC Select Agent Control, and USDA Compliance• Management/Leadership Skills • Compliance • Quality Assurance/Systems• Quality Control • GMP Manufacturing • Incoming Quality• Auditing • Inspection Lead/Host • Project Management• Personnel Development • Training • Scheduling• Sterilization/Sterility Assurance • Validation • Investigation analysis/reporting• Metrics/Data Processing • Risk Assessments • Supplier Management• CAPA • Gap Assessments • eQMS• Water Systems • OpEx • Quality Improvement Planning• Peer/Subordinate Coaching and Team Building • Written and Verbal Communication Skills

Experience

1. Director of Quality

   Piramal Pharma Solutions

   Aug 2024 — Present

Education

• Siena Heights University

  Bachelor's degree

Skills

• Microbiology
• Computer System Validation
• Sap
• Trackwise
• Sterility Assurance
• Vaccines
• Quality Management
• Contract Manufacturing
• Technology Transfer
• Cleaning Validation
• Validation
• Project Management
• Biotechnology
• Process Improvement
• Continuous Improvement
• Quality Control
• Gmp
• Quality Assurance
• Environmental Monitoring
• Pharmaceutics
• Sterilization
• Regulatory Affairs
• Lifesciences
• Purification
• Gxp
• Quality Auditing
• Aseptic Processing
• Regulatory Submissions
• Healthcare
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Fda
• Cross-Functional Team Leadership
• 21 Cfr Part 11
• Laboratory
• Biopharmaceuticals
• Clinical Development
• Regulatory Requirements
• Quality System