Swetha Krishnan Email and Phone Number
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With extensive experience in global quality systems within the biopharmaceutical sector, I bring expertise in Quality Assurance, Validation and Digital Quality and Compliance. My career has been marked by the development and fortification of quality management processes, ensuring strict regulatory compliance, and optimizing digital quality initiatives. Notable accomplishments include effectively managing sizable teams and budgets, orchestrating successful regulatory audits, and championing continuous improvement efforts.I've been an active contributor to influential quality leadership committees, advocating for contemporary methodologies that deliver tangible outcomes, while maintaining the delicate balance between operational excellence and compliance. My commitment extends to advancing quality frameworks to uphold the highest standards in the biotech industry.I'm passionate about leading with empathy, building high-performing teams, and collaborating with key stakeholders and external partners. This partnership has driven risk-based approaches to implement and manage global GxP processes, operations, and quality systems, spanning from R&D through Commercial.Furthermore, I have a deep-seated enthusiasm for driving efficiencies through innovation and digital transformation. My focus extends beyond meeting business needs to ensure scalable, sustainable, cost-effective, efficient, and compliant solutions and services that drive excellence throughout the organization.
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Executive Director, Head Of QualityMural Oncology Nov 2023 - PresentWaltham, 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. -
Senior Director, Quality Systems & ComplianceAlkermes Mar 2021 - Nov 2023Dublin, 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. -
Director, Quality Systems And ComplianceAlkermes Nov 2018 - Mar 2021Dublin, Ie -
Associate Director, ValidationAlkermes Dec 2017 - Oct 2018Dublin, Ie -
Manager Computerised Systems Compliance, Global Quality CscSanofi Dec 2014 - Nov 2017Paris, 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 -
Senior Quality Engineer - Qa EsystemsSanofi Jan 2014 - Nov 2014Paris, 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 -
Quality Engineer, Qa EsystemsSanofi Jun 2012 - Jan 2014Paris, France, Fr -
Qa Lead ConsultantBiogen Idec Nov 2011 - May 2012Cambridge, Ma, UsIn 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. -
Sr. Validation ConsultantGenzyme May 2011 - Dec 2011Paris, 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. -
Sr. Qa ConsultantBiogen Idec Nov 2008 - May 2011Cambridge, 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. -
ConsultantPfizer Inc. 2006 - 2008- 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.
Swetha Krishnan Skills
Swetha Krishnan Education Details
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Mit Sloan School Of ManagementExecutive Mba -
The University Of ToledoBioengineering -
Mumbai UniversityBiomedical Engineering
Frequently Asked Questions about Swetha Krishnan
What company does Swetha Krishnan work for?
Swetha Krishnan works for Mural Oncology
What is Swetha Krishnan's role at the current company?
Swetha Krishnan's current role is Quality Executive | Biotech/Pharma | Mural Oncology | MIT Sloan MBA | Mentor.
What is Swetha Krishnan's email address?
Swetha Krishnan's email address is sw****@****ofi.com
What is Swetha Krishnan's direct phone number?
Swetha Krishnan's direct phone number is +190854*****
What schools did Swetha Krishnan attend?
Swetha Krishnan attended Mit Sloan School Of Management, The University Of Toledo, Mumbai University.
What skills is Swetha Krishnan known for?
Swetha Krishnan has skills like Quality Assurance, Validation, 21 Cfr Part 11, Quality System, Change Control, Fda, Testing, Requirements Analysis, Sdlc, Software Documentation, Gxp, Sop.
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