Carol Oliveira

About Carol Oliveira

Experienced Leader with a demonstrated history of working in the pharmaceuticals industry. Strong quality assurance professional skilled in Change Control, Biotechnology, Biopharmaceuticals, Regulations, and U.S. Food and Drug Administration (FDA).

Experience

1. Head of Analytical Services External Small Molecules and Oncology

   Takeda

   Aug 2023 — Present · Lexington, MA, US

   Responsible for the oversight of analytical team with oversight of all third-party labs supporting outsourced commercial and stability testing. Responsible for associated Analytical budget supporting the OncESSM Takeda release and commercial stability program, providing detailed forecasts and assessments of spend. Responsible for assuring the resolution of all laboratory events in a timely and compliant manner and reporting any events that could indicate a product issue or require regulatory communications. Collaborates with commercial and global teams to develop standards and policies related to laboratory and testing activities as well as vendor oversight requirements for Takeda. Assure the appropriate assessment of methods, specifications, stability protocols, development reports, analytical validations, analytical transfers, statistical packages, expiry extensions, analytical reports and the assessment of critical analytical changes or deviations, as needed to assure compliance to Takeda standards, regulatory requirements and GMPs. Subject Matter Expert (SME) in relevant current and emerging regulatory requirements and industry best practices. Drives External Supply Quality (ESQ) teams on testing strategies for new or existing products to ensure GMP and Takeda expectations are met. Ensures the establishment of remediation plans if needed to improve analytical testing strategies. Drives innovation and efficiency including electronic data exchange and stability interval test reductions, not compromising compliance nor product quality.

Skills

• Change Control
• Program Management
• Biopharmaceuticals
• 21 Cfr Part 11
• Validation
• Corrective and Preventive Action (Capa)
• U.s. Food and Drug Administration (Fda)
• Quality Assurance
• V
• V&V
• U.s. Title 21 Cfr Part 11 Regulation
• Project Planning
• Quality Control
• Gmp
• Standard Operating Procedure (Sop)
• Lims
• Biotechnology
• Pharmaceutical Industry
• Sop
• Fda
• Capa
• Technology Transfer