Swetha Krishnan Email & Phone Number

Waltham, Massachusetts, Us

- Oversee all quality aspects, encompassing Clinical, Development, and External Quality Assurance, Validation and Quality Control, GCP, GLP, GvP, GMP, GDP, and other regulated activities.- Manage the quality assurance, quality control and validation processes across Mural Oncology's entire pipeline, spanning from development to commercial manufacture.- Direct quality oversight across a vast external network, including CROs, CDMOs, Laboratories, Suppliers, and Vendors.- Serve as a pivotal member of Mural Oncology's leadership team, actively influencing the Quality strategy.- Design, implement and uphold best-practice quality programs and policies resulting in robust management and oversight of clinical trials and drug development.- Maintain an efficient vendor management program, streamlining audit processes and ensuring swift resolution of any audit findings.- Establish Inspection Readiness program to ensure successful outcomes during regulatory inspections.- Champion the integration of cutting-edge automated quality systems.- Engage continuously with global regulatory agencies on GMP and clinical quality domains.- Ensure proactive assessments and stay aligned with the evolving Data Integrity guidelines.- Promote a robust quality culture by spearheading projects aimed at enhancing overall product quality.- Keep a vigilant eye on industry trends, ensuring Mural Oncology is always ahead of potential impacts.

Dublin, Ie

- Key member of the Global Quality Leadership Team, Quality Compliance Committee, and Clinical Quality Review Board.- Oversaw the Corporate Global Quality Systems and Compliance department, encompassing quality systems management, computer systems validation, compliance training, and site compliance.- Managed a $2M budget and led a team of 30 spanning QA, quality systems management, and compliance.- Facilitated successful regulatory inspections with agencies including FDA, HPRA, and ministries in Russia and Belarus; supported two NDAs via pre-approval inspections.- Spearheaded the consolidation of e-QMS platforms, saving $0.5M and boosting efficiency by 30%.- Established Quality Systems Governance across all sites and drove modernized computer software assurance practices, from R&D to Commercial.- Revamped the Quality Manual, securing senior management endorsement.- Initiated a risk-based Vendor Qualification process, overseeing 50+ annual computer system vendor qualifications.- Acted as the site's Quality Risk Advocate, managing escalations.- Presented Quality System metrics to top management, maintaining a >95% on-time training completion rate globally.- Led Quality Culture initiatives and critical continuous improvement projects.- Led Quality and Process Workstreams, aiding in pivotal company transition activities.

Dublin, Ie

Dublin, Ie

Paris, France, Fr

- Supported CS quality and compliance for global multisite systems.- Oversaw GxP System Inventory, CAPAs, Deviations, Investigations, and Periodic Reviews for global GxP operations.- Assisted with risk identification and escalations.- Played a role in crafting global quality documents.- Directed Inspection Readiness assessments and offered on-site inspection support.- Championed the North America networks to enhance site CS compliance maturity.- Head the Global CS Compliance training program, creating, and delivering tailored content across the organization.- Conducted internal audits and supervised IS Supplier audits for global computerized systems.- Engaged in Lean Management, pinpointing process gaps via value stream mapping.- Led and supported internal and IS Supplier (Third Party) audits for IS-supported global computerized systems

Paris, France, Fr

- Business Quality Representative (BQR) on various quality systems (Trackwise, Plateau, StarLIMS, Empower, Livelink, Stature, Mfg-Pro, Nugensis, iLiMS and LiMSlink) implementation teams.- BQR on Change Controls with GxP impact pertaining to IT systems- Responsible for life cycle management of computer systems in compliance with standards and regulations (GAMP5, 21 CFR Part 11, Annex 11 etc.).- Involved with CAPAs, Deviations and Investigations, Periodic Reviews associated with enterprise quality systems supporting GxP operations.- Participate in IS Supplier audits and support corporate and third party audits for enterprise quality systems

Paris, France, Fr

Cambridge, Ma, Us

In the capacity of a QA Lead, I was involved in developing a comprehensive Validation/Testing Strategy for the Windows 7 Upgrade project, performing Compatibility Assessments, and developing the Risk Mitigation Strategy. I also worked on a web-based RiskMAP application, initiating, processing and tracking change requests, leading and managing QA/validation activities, as well as providing a liaison between between the business and offshore resources.

Paris, France, Fr

- Spearheaded the validation of the Blaze LIMS upgrade, a pivotal project enabling Genzyme to efficiently scale operations for an extensive clinical trial.- Masterminded and endorsed system lifecycle documentation and critical validation deliverables.- Orchestrated User Acceptance Testing (UAT), culminating in the creation and execution of a comprehensive regression test suite.- Delivered periodic validation status reports to stakeholders and project teams for transparency and alignment.- Administered deviation management guaranteeing prompt resolution and close-out of identified issues.

Cambridge, Ma, Us

- Instrumental in establishing rigorous QA processes, ensuring optimal product and service quality.- Led comprehensive training sessions, elevating team capabilities in maintaining quality standards.- Partnered with Marketing Team to roll out TOUCH & TOUCH-online apps for TYSABRI REMS; secured 80% online adoption.- Directed validation of Siebel CRM, unifying data from preclinical planning to post-launch, streamlining business operations.

- Collaborated with the Worldwide Safety and Regulatory Operations Group on global regulatory submission processes.- Led deployment of a validated, inspection-ready technology suite.- Established advanced content management & collaboration solutions, consolidating multiple regulatory systems.- Roles: Validation Engineer, Technical Writer, Business Analyst, Support.

Executive Mba

Ms, Bioengineering

Be, Biomedical Engineering