RUCHIKA CHANDRAN M.A., RAC (US)

224-***-**** § admz6b@r.postjobfree.com

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Summary

· Quality and Compliance (Q&C) leader and seasoned Big 4 consulting professional with breadth of experience in clinical, research (R&D), manufacturing and corporate settings and in building high-performing teams

· Partners closely with global executives in a matrix model, to drive transformation and a culture of quality, optimizing operations, governance, and spearheading Quality improvement and remediation initiatives

· Collaborates cross-functionally to drive consensus and leverage the power of digitization, automation and analytics to deliver effectively and enable Quality data-driven insights and actions

· Maintains Regulatory Affairs Certification (RAC, US) and has keen understanding of industry standards and FDA and global health authorities’ GxP regulatory requirements for the Life Sciences industry (including but not limited to: ISO, ICH, 21 CFR Parts 11, 50, 210, 211, 820, GDP, cGCP, cGLP, cGMP, Data Integrity, etc.)

· Stellar record of accomplishment with assessing information, understanding complex issues and objectives, thinking outside the box and building innovative approaches to deliver desired results for the enterprise

· Passionate leader who values integrity, inclusion and a culture of mentorship and innovation. Seeking senior executive opportunities to make an impact through developing and delivering on a shared vision. Areas of Expertise

Leadership and Management

· Leadership role in developing consulting and delivery capabilities for EY’s Q&C solutions, to meet present and future state operations, transformation and growth needs of the Life Sciences industry

· Stakeholder and change management for greater buy-in and effectiveness of initiatives

· Recruit, manage and mentor staff and experienced hires to build high-performing teams

· Keep abreast of industry trends, advise clients and lead strategic projects with budgets up to $5M.

· Manage global teams delivering QMS, CAPA, Health Authority findings remediation and GxP Compliance and Audits projects for Life Sciences clients. Track record of winning high value, follow-on work with leading Life Sciences clients

Quality Management Systems

· Lead the development and delivery of QMS transformation and remediation programs with end-to-end harmonization, governance and change management across QMS sub-processes and the product lifecycle. Focus on delivering business value, Quality outcomes and right-sized Compliance posture

· Leveraging the power of analytics, digitization, trending and automation to provide actionable insights and improve efficiency and effectiveness of delivery of QMS processes Corrective Action and Preventive Action (CAPA)

· Lead and drive process redesign, improvement, remediation and timeliness (through appropriate governance, visibility, accountability and prioritization) Data Integrity and Computer Systems Validation

· Establish and/or enhance risk-based approach to verification/validation of infrastructure and systems supporting enterprise and GxP processes. Assess and remediate data integrity gaps. Audit, Inspection and Remediation

· Audit and CAPA management using a risk-based approach incorporating FDA’s QSIT (Quality Systems Inspections Technique) to internal and external audits Regulatory

· RAC(US) certified and keen understanding of GxP regulatory requirements across the product lifecycle Therapeutic Areas/Clinical

· In-depth understanding of various therapeutic areas based on clinical training and research experience Representative Life Sciences Experience (Fortune 100 and 500 companies) Enterprise Mindset and Strategic Thinking

· Advised and worked alongside Global Quality Leadership Team (GQLT) of a Fortune 100 client on a multi-year, Quality Management Systems (QMS) improvement program. Led efforts to define future state vision and roadmap, providing key insights to harmonize end-to-end QMS processes, IT architecture and solution modernization considerations

· Leading the development of solutions to address EY clients’ and their customers’ current challenges and the industry’s future needs

RUCHIKA CHANDRAN M.A., RAC (US)

224-***-**** § admz6b@r.postjobfree.com

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Change Agility and Risk Management Mindset

· Mobilized SWAT team and set up a one-stop-shop Compliance command center in response to a cyber incidence with global impact on client's IT systems. This provided a unified global interface, organizational structure and processes to support restoration of infrastructure and business applications in a compliant manner. The command center model provided immediate ROI in coordinating Compliance processes for the cyber recover and continued value realization for ongoing operations

· Led global team supporting end-to-end corporate IT Deviation/CAPA Management operations across divisions, driving process improvements and significantly reducing backlog and operating costs. Standardized and simplified processes and operations to enable a long-term managed service model and enable further long-term cost reductions (of >30%)

· Led the design of IT Compliance "factory" service related to a major transaction (spin-off) for a Fortune 100 client using a risk-based approach to develop risk-based computer systems validation protocols, and set up a stage-gate/monitoring system to support global IT separation activities Quality and Continuous Improvement Focus

· Improved processes and developed dashboards to provide visibility to audit schedules and developed a data-driven CAPA tracking system and analytics to monitor progress, enable prioritization and executive- level reporting

· Advised leading global Biopharmaceutical client on model to structure an end-to-end Quality Management System with feedback loops, spanning the product life cycle from R&D to commercialization. Made recommendation to address their challenges with integrating silo quality processes within business functions into the corporate quality management framework

· Harnessed value/stream mapping to optimize IT Quality Assurance processes, deliverables and reporting structure(s), by identifying redundancies and process simplification opportunities Regulatory and Health Authority Findings Remediation Experience

· Managed engagement for Life Science client encompassing gap assessment of quality records and recommended 483 remediation frameworks across four Quality functions - Complaints, Corrective Action and Preventive Action (CAPA), Computer System Validation and Training

· Worked with leading Medical Device client on Complaints management system updates and implementation to remediate compliance gaps and to enable system to support industry leading practices and adverse event reporting requirements. Lead a team supporting end-to-end implementation of all updates including computer system validation activities and documentation

· Developed a holistic QSIT-based quality system remediation plan to support an FDA 483 response for API manufacturing site. Established project milestones aligned with FDA commitments, collaborated with local and global division leads of Fortune 500 company to enable them to meet FDA commitments

· Managed and supported the delivery of training/re-training to over 400 site personnel in the areas of QMS, GDP, CAPA and Root Cause Analysis, and Inspection Readiness

· Implemented an end-to-end Quality oversight program for cGMP-compliant batch production and analytical quality control (AQC) activities for oncolytic APIs. Oversight program was instrumental in a successful post-Warning Letter FDA inspection

· Supervised completion of consent decree CAPA commitments, site wide CAPAs, CAPA process improvements and CAPA Review Board meetings as Interim CAPA SME for global brand leader in cardiovascular perfusion and monitoring systems. Mentored a team of CAPA engineers at US headquarters on CAPA implementation, while monitoring timelines and CAPA metrics to reduce opens CAPAs by approximately 50% in under a year

Professional History

Ernst & Young, LLC (EY) 2015 − present

Senior Manager, Business Consulting, Enterprise Risk Manager, Advisory, Risk Transformation

· Leadership role in EY’s Quality & Compliance (Q&C) practice, serving in various capacities as Q&C SME and building strategic and tactical solutions to serve our Life Sciences clients

· Independently own executive client relationships in a matrix environment, develop proposals, and spearhead client delivery, leading and managing a diverse global delivery team across regions

· Recruit, manage and mentor staff and experienced hires to build high-performing teams RUCHIKA CHANDRAN M.A., RAC (US)

224-***-**** § admz6b@r.postjobfree.com

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Regulatory Compliance Associates, Inc. 2012 − 2015 Consultant/ Regulatory Affairs Specialist

· Project lead, team member and independent contributor for Regulatory Affairs and Quality Systems Compliance solutions for global pharmaceutical and medical device clients

· Process-mapping solutions to optimize quality management system business processes and the software development life cycle processes for Life Sciences clients

· Support business development, ISO certification, business contracts, project management, site audits and development of training and product tools

University of Iowa, Graduate Program in Physical Therapy and Rehabilitation Science 1998 − 2004 PhD candidate and Research & Teaching Assistant:

· Independently designed multiple research studies with lead role in coordinating study protocol among multiple departments at the University of Iowa such as: Orthopedics, Orthopedics Gait Analysis Center, Student Health, Athletics, Reproductive Endocrinology and Clinical Research Center

· Collaboratively developed proposals and secured funding for projects through NSF (National Science Foundation), Wellmark® Blue Cross and Blue Shield, DePuy (a Johnson & Johnson company) and Organon (former Schering-Plough)

· Obtained IRB approval, screened and recruited subjects through the University of Iowa Hospital and Clinic, VA Hospital and the University of Iowa and general community

· Communicated findings in thesis, scientific abstracts, national conferences and peer-reviewed journals

· Mentored graduate students through research projects and supervised clinical skills laboratories in kinesiology and musculoskeletal therapy

Clinical Experience

Rehabilitation Therapies, University of Iowa Hospitals and Clinics, Iowa City, IA 1998 − 2001

· In-patient orthopedic physical therapy (assist in post-operative joint replacement rehabilitation) Manipal Heart Foundation, Bangalore, India 1998

· Established the physical therapy program and implemented protocols for pre-and post- cardiac surgery physical therapy for pediatric and adult patients

· Mentored new physical therapists and developed reference guidelines National Institute of Rehabilitation Training and Research, Cuttack, India 1994 − 1998

· Medical training and clinical rotations in orthopedic, neurological and cardiovascular rehabilitation

· Hands-on rehabilitation clinical experience treating patients with orthopedic, neurological, infectious disease and genetic conditions

Honors and Awards

· Graduate of selective EY Americas Transformative Leadership Program, 2020

(one of three Senior Managers to be selected across the Americas from EY’s Enterprise Risk competency)

· Recipient of three EY Culture Coins, 2015, 2017, 2019

(awarded to select personnel who “live EY values and reinforce our culture of: integrity, respect, teaming, demonstrate enthusiasm and the courage to lead, and build relationships based on doing the right thing”)

· Alumni Scholarship, University of Iowa, 2003

· Whitaker Foundation Student Award (supported biomedical engineering education and research), 2002

· National Gold Medal, Indian Association of Physiotherapy, 1998

· Alka Verma Memorial Trophy, Student Award, Indian Association of Physiotherapy, 1997 Education & Training

· Regulatory Affairs Certification (RAC), held since 2011

· Ph.D. (ABD), University of Iowa

· M.A., University of Iowa

· B.P.T. (Bachelor’s in Physical Therapy), Utkal University, India (National Gold Medalist) References and Publications: Available upon request

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