Mandy Gervasio
S. Dartmouth
Summary
GxP quality and compliance leader with proven expertise in enhancing inspection readiness and reducing compliance risks. Proficient in GxP QMS design and data analytics, fostering collaboration across functions and driving continuous improvement. Dedicated to achieving operational excellence and ensuring regulatory compliance in fast-paced environments.
Overview
24
24
years of professional experience
1
1
Certification
Work History
SVP, QA & Chief Risk & Compliance Officer
Comanche Biopharma
06.2025 - Current
- Spearheaded enterprise QA strategy and a multi-year QMS roadmap across CMC, Clinical, Nonclinical and IT, aligning quality objectives to product roadmaps and clinical milestones.
- Designed and deployed integrated QRM and ERM frameworks; prioritized remediation investments and secured Board approval of risk appetite and remediation funding.
- Founded and chaired the Quality & Risk Council (QRC) to govern cross-functional risk, streamline escalation, and accelerate executive decision-making.
- Built and scaled compliance systems (CAPA, change control, EDMS/eQMS governance, training, vendor oversight), cutting compliance events and shortening corrective-action cycle times.
- Operationalized CSV and e-systems validation (GAMP-5) for cloud platforms and enforced data-integrity controls to ensure audit and inspection readiness.
- Established global vendor assurance and CRO/CMO audit programs, reducing supplier-related deviations and accelerating supplier qualification.
- Integrated privacy and data-protection controls for regulated data (HIPAA, GDPR) into QMS and CSV processes; coordinated privacy impact assessments and vendor controls.
- Delivered analytics-driven executive dashboards and KPI reporting; presented remediation ROI and quality metrics to senior leadership and the Board.
Vice President, Quality & Compliance
Comanche Biopharma
12.2021 - 06.2025
- Designed and deployed a scalable, risk-based QMS aligned to ICH/FDA/ISO, driving inspection readiness across clinical, CMC and digital domains.
- Partnered with CMC, to design batch disposition and release controls, improving release throughput and enabling timely clinical supply.
- Led global QA & compliance teams, instituting KPI-driven governance and initiatives that improved CMO delivery timelines.
- Developed and launched role-based training and competency programs, increasing quality training completion and operational compliance.
- Implemented enterprise risk management and mitigation plans, reducing key compliance risks and improving control effectiveness.
- Directed internal/external audit programs and vendor qualification, strengthening supplier oversight and action planning follow-through.
Director, Quality & Compliance
Acorda Therapeutics
05.2020 - 06.2021
- Led the development and implementation of quality management systems to ensure compliance with regulatory standards and best practices for commercial stage maturation.
- Managed cross-functional teams to conduct internal audits and compliance assessments, identifying areas for improvement and ensuring corrective actions were taken.
- Monitored regulatory intelligence ends and changes in regulations to proactively adapt quality and compliance strategies.
- Utilized data analytics to track quality metrics, driving informed decision-making and strategic initiatives to enhance organizational performance.
VP, QA & Regulatory Compliance
Experic
05.2018 - 12.2019
- Owned enterprise quality and regulatory strategy for new CDMO facility, defining phase-appropriate QMS and GMP controls to support client programs across clinical and scale up commercial manufacturing.
- Led QA and QC oversight, including ownership of the facility’s controlled-DEA drug program, ensuring compliant handling, documentation, and release of controlled substances.
- Built and drive supplier quality and vendor qualification programs, strengthening supply-chain controls and reducing supplier deviations.
- Managed external audits and regulatory interactions, resolving findings and driving corrective actions.
- Led new facility CQV commissioning and ISO 13485/ISO certification, establishing medical-device QMS controls and sustaining certification through audit cycles.
- Established performance metrics and dashboards for quality operations, enabling executive reporting and continuous improvement across manufacturing and QC functions.
Business Development Manager
Life Sciences Consulting
05.2017 - 05.2018
- Developed and executed BD strategy for Life Sciences consulting, expanding the pipeline and improving proposal conversion.
- Scoped/priced complex GxP/QMS engagements and led RFx responses and client pitches as primary technical-commercial POC.
- Mobilized multidisciplinary consultant teams to deliver projects on time and profitably.
- Created standardized sales collateral and technical playbooks (CSV, eQMS, remediation) to shorten proposal turnaround and increase win rates.
President, Owner
MG Quality Solutions, LLC.
05.2015 - 06.2017
- Provided executive advisory and program leadership for Quality Management Systems design and implementation.
- Conducted PAI and commercial readiness assessments, facilitating ISO 13485 certification for clients.
- Led QMS commissioning for combination products, integrating device controls with drug CMC requirements.
- Scoped and directed remediation initiatives, enhancing compliance metrics and inspection readiness.
- Developed cloud eQMS strategy and CSV lifecycle frameworks for improved operational efficiency.
- Created SaaS validation roadmaps and vendor assurance approaches for enterprise deployments.
Principal Consultant, Global IT Quality & Risk Management
Cornerstone OnDemand
05.2015 - 06.2017
- Defined IT quality governance: established policies, procedures, and roles for GxP-relevant IT systems and service providers.
- Led vendor assurance and third-party risk programs for cloud providers and SaaS vendors, including SLAs, audit rights, and remediation tracking.
- Coordinated cross-functional compliance evidence packages for SOC/FedRAMP/SOC 1 & 2 audits and regulatory inspections.
- Implemented metrics and dashboards for IT quality and risk (mean time to remediation, control effectiveness, audit finding trends) to inform executive risk decisions.
Lead Quality Engineer, Commercial Expansion
Catalent Pharma Solutions
03.2014 - 05.2015
- Collaborated with engineering and manufacturing teams on commercial site expansion for new product launch, ensuring compliance with regulations and standards.
- Established and monitored key performance indicators for quality objectives to drive continuous improvement.
- Monitored supplier performance against established metrics to ensure high-quality component delivery.
- Provided guidance and training on Quality Assurance topics to enhance departmental knowledge.
Various QA/QMS roles
Genzyme Sanofi, Vertex, Pfizer, Genentech, Exemplar Labs, Xcellerex, Acambis
12.2001 - 12.2013
- Conducted internal audits to assess compliance with QMS requirements.
- Provided training on the use of QMS tools such as document control, corrective action and internal auditing.
- Managed the development and maintenance of quality management systems (QMS), ensuring continuous improvement and efficiency.
- Collaborated with multiple departments throughout an organization to ensure full integration of QMS into daily operations.
- Performed risk assessment and FMEA reviews with suppliers to identify potential issues before they arise.
Education
MS Degree - Leadership
Northeastern University
Boston, MA06.2010
BS - Biology
University of Massachusetts Dartmouth
North Dartmouth, MA06.2002
Skills
- Enterprise Quality Leadership & Global GxP Compliance (GLP, GCP, GMP, GDP, GVP)
- QMS Design, Scalability & Optimization (GMP/ISO Standards)
- Regulatory Intelligence & Health Authority Engagement (FDA, EMA, MHRA, PMDA)
- Inspection & Audit Strategy Inspection Readiness & Continuous Compliance
- Risk Management & Governance (QRM/ERM) Risk-Based Decision Making
- Digital Quality Transformation eQMS, SaaS/CSV, GAMP 5 Implementation
- Continuous Improvement & Operational Excellence (Lean Quality, Metrics, CAPA)
- Vendor & Supplier Quality Oversight (CROs, CMOs, CDMOs)
- Data Integrity & Governance (ALCOA Principles, Lifecycle Data Controls)
- KPI Development, Analytics & Quality Performance Reporting
- Strategic Leadership, Change Management & Talent Development
Certification
• Applied Data Analytics (Certificate) MIT
• Regulatory Affairs Expert Certification (ACMA)
• Six Sigma Lean Blackbelt Six Sigma Global Institute
• COSO ERM Certificate- The Institute of Internal auditors (IAA) In progress: Target Completion Dec 2025
• Regulatory Affairs Expert Certification (ACMA)
• Six Sigma Lean Blackbelt Six Sigma Global Institute
• COSO ERM Certificate- The Institute of Internal auditors (IAA) In progress: Target Completion Dec 2025
Career Highlights
- Led a successful PAI/commercial readiness program enabling on-time regulatory submissions and materially reduced inspection findings through targeted remediation and readiness simulations.
- Reduced lot-release cycle time and improved release throughput by optimizing batch disposition and cross-functional release controls.
- Consolidated and harmonized multi-site QMS/eQMS platforms, eliminating duplicate processes, improving data integrity, and OPEX savings.
- Built a risk-based global vendor assurance program (CRO/CMO/suppliers) that lowered supplier failure rates and accelerated supplier qualification timelines.
- Implemented automated CAPA and quality workflows (eQMS integrations), shortening CAPA closure time and improving CAPA effectiveness and trending.
- Secured executive sponsorship and funding for a multi-year QMS transformation roadmap; established KPIs and demonstrated ROI through reduced compliance events and faster time-to-release.
Timeline
SVP, QA & Chief Risk & Compliance Officer
Comanche Biopharma
06.2025 - Current
Vice President, Quality & Compliance
Comanche Biopharma
12.2021 - 06.2025
Director, Quality & Compliance
Acorda Therapeutics
05.2020 - 06.2021
VP, QA & Regulatory Compliance
Experic
05.2018 - 12.2019
Business Development Manager
Life Sciences Consulting
05.2017 - 05.2018
President, Owner
MG Quality Solutions, LLC.
05.2015 - 06.2017
Principal Consultant, Global IT Quality & Risk Management
Cornerstone OnDemand
05.2015 - 06.2017
Lead Quality Engineer, Commercial Expansion
Catalent Pharma Solutions
03.2014 - 05.2015
Various QA/QMS roles
Genzyme Sanofi, Vertex, Pfizer, Genentech, Exemplar Labs, Xcellerex, Acambis
12.2001 - 12.2013
MS Degree - Leadership
Northeastern University
BS - Biology
University of Massachusetts Dartmouth