Operations Excellence - PMO & Regulatory Quality Leader

https://www.linkedin.com/in/anitra-maynette-a**a**

Summary of Qualifications

Operational Excellence – PMO; Quality

Quality/Compliance Regulatory oversight/Integrity & Innovation, Product Launch, Cloud Computing Program management execution experience in GAMP; ISO 13485 (Med Devices); GAMP 5, 21CFR Part 11; Annex 11,Auditing (Internal/External);

Project & Program Management. Quality & Document Management Systems; Global Role-based Training; Drug Safety, Labeling, Global Change Management/Incident Management/Change Control/Release Management; Customer Success. Pharma, Medical Device, FDA, QSR, ISO 13485, GXP/GMP, GAMP5- CFR 21Part 11/820; QA Validation/CSV, IQ/OQ/PQ Protocols/Specs, Requirements (URS/DS/FS/SOWs, SLAs) NCRs, Validation/Testing, Risk-based CSA implementations

Controlled documents: SOPs, Re-engineering, Process design; Regulatory audits/assessments, risk management

Trains and Facilitates Internal and External QA Regulatory Audits/Assessments/Inspections for GXP readiness.

IT Compliance: Cloud Security (SaaS) Governance, Risk & Compliance CSV/VMP

Governance-Quality/Compliance Operations (GRC) & Portfolio Management., Cloud Validation/Master Plan, SaaS, OKTA

Information Security - ISO 90001 - 27001/2; ISO 42001 Artificial Intelligence (AI) Framework compliance, FedRAMP ATO Certification/Recertification, (3PAO/FedRAMP PMO); SOC2, ITIL; Information Technology: SaaS OnDemand – Digital /Enterprise Management– IaaS/Infrastructure; Remote Quality & Compliance; Multi-Cloud Operations/Support, IT Service Management, BMC Helix ITSM, Veeva Vault Admin, Qualification/Migration -Data Center Qualification.

Technical Skills and Expertise

Software/OS/Platforms: Information Technology: SaaS OnDemand - Digital Management Systems – GRC/Compliance Infrastructure -Sun Solaris -Microsoft Office & Visio -MAC_OSX, ERP- Oracle-SAP, Concur, ECM, Livelink, IBM, MES, Atlas, eDMS, Web-Training, Maximo, Trackwise, SharePoint, SDL-Tridion, HP, Mercury, VMWare, Clarity, NetSuite, Veeva-CRM/ Vault LMS-Learning Management, Cyber- Security, Active Directory, MDM Argus - Drug Safety, Confluence, JIRA/Confluence, Operations, Software Development, R&D, Technical Program Management; Cloud, Strategy, Security, Implementation, App Migration, (Hybrid/Private/Public Cloud), Amazon (AWS), OKTA

Professional Experience

Sana Biotechnology South San Francisco 2023-Present

PM Lead – Veeva QDocs, Vault Training Implementation (Jan 2023 – Present), Providing SME guidance for the implementation of Veeva modules using Risk-based Cloud Validation (CSA). Including Training, DCC, Workflows etc. (Train-the-Trainer) Trained new users, set up DACs and accounts as needed. Helps support the QA/QMS/GLP/GCP & IT teams throughout the entire build/go-live.

Consulting Projects: 2018 – 2022

oFujifilm Diosynth Biotechnology

oFive Prime Therapeutics/Amgen

oGlobal Blood Therapeutics

oBeigene Pharmaceutical

oMyovant Pharmaceutical

Provides Quality (QMS) PM Oversight/Governance – Risk Assessments, CAPA/Remediation, Validation (CSV)

●Primary oversight resource for SaaS application(s) integrations /implementations & sustainability & QMS, Bus & IT bridge

●Authors, reviews, and approves SOP, Policies, Training material and other deliverables as required throughout the SDLC.

●SME contact for Veeva implementing /Veeva Project Vault (QDocs, QMS, Vault, RIMs), verifying & approving changes.

●Works with Integration Partners & internal teams, supports UAT, helping to implement/onboard SaaS Applications

●Partners with IT, Validation, and Business Partners to ensure compliance and training of key deliverables.

●Provides guidance on Policies and SOPs, Functional Requirements/Docs and reviewed/approved them manually/online.

BMC Helix 2014 – 2023

Sr. Mgr. Cloud Governance Tower – Cloud Solutions/SaaS-Compliance & CSV/CSA

●Reports directly to VP- Operations SaaS OnDemand & VP R&D Quality, GXP/GMP/CSV/ITIL SME for the organization.

●Manages the SaaS Quality Compliance team and all activities to comply with local, Life-Science and FedRAMP regulations.

●Manages Assessments, audits of internal & external teams; responds to audit findings and works through remediation.

●Manages the Compliance, Risk and Change team SMEs and third parties through attaining FedRAMP ATO, ISO, C5, IL4/IL5

●Partners with stakeholders, Functional team members and Vendors on complex IT QMS SaaS initiatives & Customer Success

●Owns Datacenter Migration Quality readiness process (Physical/Virtual -OnPrem & Colo facilities) & Audits.

●Maintains quality systems to ensure the highest quality products/services is produced/delivered to customers.

●Responsible for driving quality into Product launches supporting all customers (Federal Government, GXP, Financial, etc.)

●Trains and develops personnel on Quality initiatives, objectives and maintains the Quality Document Management structure.

●Leads the bi-weekly Quality/Risk (QA/CSV/CSA) forums involving multiple sites and key cross-functional executive members.

Cisco Systems – Governance Lead Consultant - InfoSec Risks - FISMA/Fed RAMP ISO Control PM 2013-2014

27001/ISO Information Security Policy Program Training & Compliance Consultant (Compliance & Auditing)

●SME on ISO Regulations engaging business stakeholders identifying, drafting and auditing controls.

●Consulted across multiple organizations on best practices for Cisco Cloud Services, WebEx (and all systems within InfoSec)

●Consulted with external Vendors (KPMG, E&Y) with Corp initiatives (e.g. FedRamp)

●Performed audits of ISO 9001/27001-2 and Cloud-based systems

Gilead 2013 –2013

Sr. Mgr. (GXP) Consultant (SaaS, Veeva, Maximo, eDMS, MDM, Remedy, TrackWise, Validation, CSV)

●Reporting directly to Sr. Director, IT- PM managing multi-million-dollar portfolio executing and implementing objectives

●Worked with Sales, Marketing, R&D, CRMs, Prod and directly with customers defining/improving product specifications.

●Partnered with Veeva/Integration partner to validate/implement Veeva Vault (Quality Docs, eTMF, RIMS)

●Enabling project delivery work-streams through Quality IT and MDM/Infrastructure Validation/Qualification projects

●Developed Corp guidelines for quality programs and standards that met or exceeded customer and regulatory requirements.

●Working with CRM business, IT, and QA to validate Veeva and MDM systems.

●Manages DBAs, Architects, Bus Analysts, Vendor, Validation and System Owners into successful implementation.

●Verifies and creates lifecycle deliverables (e.g., Timeline, scope, Val plan, DS, FRS, rollout plan etc.)

Affymax Pharma Inc. (Sr. IT Program Mgr. – GXP/GMP/CSV-CSA) - Palo Alto, CA. 2012 –2013

Sr. Portfolio Mgr. IT-QA Systems. (SDLC – Infrastructure- SaaS/Apps - SFDC/Veeva Vault, LMS, Argus, MDM, Livelink-eDMS, NetSuite, Cloud-Web Content Mgmt., VMWare, SSO, DR, Citrix, SAP, CSV, OKTA)

●Reported directly to Executive VP, Alliance, and PMO - dotted-lined to VP InfoSec. establishing IT-PMO

●Reviews/approves labeling (UL)/records, product specifications and other process related documents from CROs.

●Managed multi-million-dollar enterprise portfolio of applications, infrastructure planning executing, and implementing goals.

●Led Finance App (NetSuite) Implementations (JE/P2P/OTC); Drug Safety (Argus upgrade); Learning Management

●Managed the initial implementation of Sales Force /Veeva Vault and MDM across multiple groups (Sales, IT, MSLs)

●Managed International/global and multi-disciplinary Teams (Engr, DBAs, Arch, BAs USA, India and EMEA)

●Managed Drug Safety (Argus/Axway upgrade) and Learning Management System (LMS) implementations.

●Executed post-implementation strategy for continuous improvement and defined project goals and go/no-go criteria,

Novartis – Emeryville, CA. 2009 – 2012

Sr. Portfolio Manager (Cloud - QA-IT Consultant-ECM/SaaS/CSV/ICE) – SDLC - Enterprise Content Management

●Principle liaison between teams/business facilitating/organizing info and activities for global offsite migration.

●Reported to Sr. Director and presented to global executive staff on project successes, issues, gating items.

●Developed Timeline and budgets (up to $5m) addressed strategies with stakeholders and cross-functional teams.

●Performed regulatory reviews of labels, labeling, and promotional materials for conformance to regulatory requirements.

●Reviewed User Requirements, Design and Functional Specifications, and other Lifecycle documentation on numerous Apps.

●Served as key contact (SME) for the ECM Compliance Leadership Team and presented compliance issues.

●Managed Validation and QA activities for BMC Remedy team on system upgrades (versioning, post migration, docs)

●Mentored team members on processes methodologies, authored controlled documentation and managed SharePoint.

Genentech Inc. - So. SFO, CA. 2006 – 2009

Sr. Mgr. SAP QA Validation/CSV Consultant (GMP/GXP)

●Part of Roche/GNE transition team, managed SAP and production integration and interfacing team

●Liaison engaging Business, IT, System Owners, stakeholders, and external partners in project lifecycle.

●Performed risk assessments, solution definition, implementation planning, system validation efforts.

●Managed Integration planning and monitored SAP Integration, providing offshore/off hour support/ guidance.

●Facilitated team reviews, interpreted, and mobilized project team, business analysts and cross-team members.

●Performed Assessments and Validation Testing, URS/FS/DS/TS documents, and coordinated defects/issues.

●Governance & Quality Manager – (CSV QA-SAP - GMP)

oGlobal Initiative Team, managing GNE implementation of new systems into global sites (team 20-60)

oInfluenced vendors (Capgemini/EY) timelines supporting Track Wise implementation across multi-sites/Orgs.

oProvided leadership on initiatives and coordinated teams throughout delivery (governance, budget, execution).

oDefined requirements for test environments and implementations and developed Test Protocols (Plans).

oLead auditor for internal/external systems and applications (eCompliance) and Global QA systems.

Boston Scientific - Valencia CA. (GXP) 2009 – 2010

Sr. Mgr. Quality & Compliance. PMO- ERP/Interfacing Implementation (SAP Implementation)

●Managed SAP and interface Apps (SFA, Complaints, Shipping, Medisoft, Clientele) implementation.

●Influenced and updated project Timeline/Status in the “deep dive” weekly discussions with PMO and Sr. Management.

●Managed multiple teams (Fin, Sales, Mfg. Mktg., QA, Validation) regarding application concerns/issues.

●Managed vendors (Accenture) on external application support and/or conversion/integration requests.

●Planned and scheduled go-live and production support plans, tasks and future state application support

Novartis Vaccines & Diagnostics - Emeryville, CA. 2008 – 2009

Sr. QA/CSV Program Manager (SAP) GXP/GMP

●Provided global QA eCompliance guidance for regulated systems throughout Dev, QA, Production.

●Managed SAP (upgrade) and eDMS Validation providing global recommendations within cross-teams.

●Supported & approved QA testing of SAP modules (ECC 6.0, PM, QM, FI, HR, SD) for client requirements.

●Managed upgrades & change (LMS, SAP, Remedy, Maximo/TrackWise, Siebel, Sentry/CAPA, Atlas eDMS, Livelink)

●Defined lifecycle docs; authored and managed offshore/multi-site client documentation and processes improvements.

●Supported and managed interfacing mapping teams responsible for “cloud” interfacing including server, DB.

Bayer HealthCare - Berkeley, CA. 2007 – 2008

Sr. Mgr. QA-GMP /GXP Manager (SAP-QA)

●Managed implementation/deployment (TrackWise, Maximo, Clarity, SharePoint, SAP) for Bayer/Novartis acquisition

●Managed IT projects, upgrades, and deployment of application systems across platforms (HW/SW- Servers, DBs, Intranet)

●Collaborated with stakeholders developing and implementing data migration and transition plans and execution.

●Drove communication channels facilitating knowledge between PMO, Owners QA, Engr’s, Val, Sponsors, and stakeholders.

●Supported Global GMP (ETC/UL) label change control packaging /QC Ops, ordering, receipt and conduct limited labeling.

●Analyzed App packages for strategic implementation, risk mitigation, change, defect modification, tracking and reporting.

●CAPA support (TrackWise) provided SME input on deviations, investigation, & workflows

Applied Biosystems - Foster City, CA. 2005 – 2007

Sr. GMP QA. Manager/ QA Auditor - CSV Consultant

●Managed complaint systems improving accuracy and efficiency of Incident resolution/reporting.

●Managed and monitored operating expenditures/ budgets, managed vendors, and internal/external resources.

●Drove Quality metrics, VOC surveys and performed business risk analysis for Sr. executive committee/Mgmt. and stakeholders.

●Drove and oversaw QA IT compliance activities (CSV-SDLC), site Infrastructure, process changes & audits.

●Bayer Corp - Berkeley, CA Governance and Quality Mgr. (CSV-QA/Risk Manager) 2001 - 2005

●Sun Microsystems - Menlo Park, CA. Sr. Ops PM - Oracle Implementation (ISO)/Facility Relocation 1994 - 2001

Education/Special Training & Awards

2002 MBA - Global Business/Global Management MIS - Bachelor of Science/ Information Systems; Mech. Engineering

1999 US Army Military Intelligence; PMP –PMBOK; Agile; Scrum

2021 Quality Certification Program, Genentech, BMC Helix

2023 Veeva Train-the-Trainer Certificate, Gilead, Sana Biotech

2021 Outstanding Achievement Leadership Project, BMC Helix

2008 Recognition Awards, Genentech

Languages: English (Primary), Spanish (basic); German (very basic); Portuguese (basic)

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