Sheila Moran

About Sheila Moran

Results oriented leader with a proven track record of regulatory compliance and excellence for pharmaceutical products, with a focus on Injectable finished dosage forms. Over 30 years of progressive management experience in Quality Assurance, Quality Control, Microbiology, Validation, Manufacturing/Operations and Research & Development within an FDA registered environment. Expertise in pharmaceutical drug products and drug substances. Directed quality operation compliance for commercial, clinical and stability manufacturing activities as it relates to manufacturing and release of product and clinical trial materials in an aseptic pharmaceutical environment in accordance with GMPs, GLPs and GDPs. Developed quality systems, standards and policies to meet current regulations. Provided strong leadership and direction to team members by serving as a reliable resource and role model. Served as the key customer interface and technical liaison for entire business unit. Actively and successfully led regulatory inspections and client audits. Excellent at motivating others through team building, mentoring and hands-on management style. Specialties: QMSProduct LaunchMergers and AcquisitionsR & DGeneric Injectable PharmaceuticalsAPIFacility ComplianceFDA Inspection Readiness483 and Deficiency Responses

Experience

1. Senior Vice President Quality

   Woodstock Sterile Solutions

   Jul 2022 — Present · Woodstock, IL, US

   Responsible for setting the strategic direction and maintaining the Quality Management Systems to ensure the site is compliant with regulatory, company, and customer requirements. Responsible for establishing and maintaining site metrics, management review, and building a customer oriented culture. Provide batch disposition, project guidance and support to customers.

Education

• Roosevelt University

  Bachelor of Science with Honors, Biology/Chemistry

Skills

• Medical Devices
• Regulatory Requirements
• Product Quality
• Iso 13485
• Qms
• Commercialization
• Management Review
• Biotechnology
• Fda Gmp
• Vendor Management
• Risk Management
• Generic Injectables
• Global Regulatory Compliance
• Iso
• Fda
• Quality System
• V&V
• Lifesciences
• R&D
• Life Cyle Management
• Auditing
• Warning Letter Response
• Risk Assessment
• 483 Responses
• Contract Manufacturing
• Pai Readiness
• Api
• Quality Agreements
• Quality Management
• Biopharmaceuticals
• Clinical Trials
• Six Sigma
• Product Launch
• Quality Auditing
• Aseptic Processing
• Injectable
• Analytical Chemistry
• Internal Audit
• Quality Control
• Gmp