Anastasia Righter

Served as primary quality liaison for CDMOs and external partners, fostering collaboration and ensuring compliance.

Led GMP quality oversight for early and late-phase GMP external manufacturing activities.

Set quality objectives, drove risk assessments, and ensured timely closure of deliverables.

Advanced quality systems to support compliant product releases and ongoing performance monitoring.

Directed investigations, deviation follow-ups, CAPA assessments, and product impact evaluations.

Provided technical leadership for product quality decisions, reviewing compliance documentation and regulatory submissions.

Managed batch record reviews and manufacturing documentation to ensure timely release-readiness of externally manufactured products.

Conducted GxP audits of contract service providers, preparing and reporting findings to drive quality improvements.

· Led QA support for GMP manufacturing of gene therapy drug substance and drug product at U.S.-based CDMOs.

· Released clinical trial materials, ensuring compliance with GMP, regulatory, and internal quality requirements to support successful trial execution.

· Represented Quality Assurance in internal and external cross-functional meetings, driving alignment across global stakeholders.

· Supported technology transfer and manufacturing readiness, ensuring compliance oversight across CDMOs and CTLs to facilitate seamless operations.

· Reviewed batch records for GMP compliance, required testing, and alignment with regulatory filings.

· Conducted vendor audits, reviewed Quality and Technical Agreements, and supported vendor assurance activities.

· Contributed to eQMS implementation, authored and approved SOPs, and strengthened quality system infrastructure.

· Reviewed and approved QA documentation for investigations, deviations, OOS reports, CAPAs, change controls, and qualification and validation activities, enhancing quality assurance processes.

· Served as Person in Plant to support documentation review, manufacturing oversight, and real-time issue resolution.

· Extended oversight to UK- and EU-based CDMOs and supported complaint and recall management activities.

· Provided QA leadership and oversight for GMP manufacturing of gene therapy drug substance and drug product at U.S.-based CDMOs.

· Released clinical trial materials and ensured quality compliance across external manufacturing activities.

· Reviewed and approved investigations, deviations, OOS reports, CAPAs, and change controls at CDMOs.

· Approved CDMO qualification, validation, and technology transfer activities to support operational readiness.

· Reviewed draft and executed batch records and QC documentation for GMP compliance.

· Performed trend analysis and maintained KPI metrics to monitor CDMO quality performance.

Supported documentation review, manufacturing discussions, and on-site quality oversight as Person in Plant.

· Conducted external audits of GMP service providers to assess compliance and drive follow-up actions.

Managed external quality compliance for API and drug product CMOs and CTLs across Europe and North America, supporting uninterrupted supply to global markets.

Reviewed and approved investigations, deviations, CAPAs, continued process verification activities, and quality records from external partners to ensure compliance with regulatory standards.

· Led complaint investigations with external partners and supported recall activities and product quality issue resolution.

· Supported regulatory filings and health authority responses and maintained quality agreements with CMOs and CTLs.

Tracked partner quality metrics and supported audits and inspections to enhance compliance and readiness for regulatory approvals.

· Led analytical method transfers, qualifications, verifications, and validations in support of vaccine technology transfer.

Prepared APR and APQR documentation and reviewed internal and external change controls, ensuring thorough oversight of analytical changes and maintaining quality standards.

· Reviewed batch, QC, and stability documentation and released batches in SAP.

· Mentored QA team members and served as subject matter expert for sampling and testing requirements, SOP updates, and compliance communication.

· Managed external QC activities for API and drug product programs across CMOs and CTLs in Europe, North America, and Asia.

· Led analytical method transfers and validations across internal and external sites.

· Supported deviations, laboratory investigations, and CAPAs related to IPC, release, and stability testing.

· Utilized TrackWise to initiate and manage change controls, deviations, and laboratory investigations.

· Developed and managed pre-approval and commercial stability programs, including protocol authorship and maintenance.

· Reviewed and trended stability data using statistical tools such as SLIMStat and Minitab.

· Supported preparation and review of CMC regulatory filings and responses to health authority questions.

· Supported specification setting for starting materials, intermediates, drug substance, and drug product.

· Partnered with process development teams and analytical and research development to identify and qualify process-related impurities and degradants and to maintain test methods and specifications.

Led a cross-functional team in the development of an injectable medical device.

· Managed external laboratory programs, including bioanalytical testing, materials characterization, and in vivo studies.

· Supported root cause investigations, competitive analysis, and process development initiatives.

· Participated in risk management activities and collaborated closely with regulatory and clinical teams.

Developed and validated analytical methods for product testing and quality control.

Analyzed drug products using HPLC and GC methods across multiple matrices, adhering to cGMP and GLP regulations to ensure product quality.

• Developed, validated, and transferred methods per ICH and PQRI guidelines to ensure compliance and reliability.
• Conducted chemical analyses to determine composition and purity of substances.
• Collaborated with cross-functional teams to improve laboratory processes and protocols.