Quality Assurance

Sharon Wong

*** ******** ******, ********, ********** 94044 ********@*****.*** 415-***-****

Professional Profile

Experienced, quality-driven scientist with 25+ years of global strategic experience in Clinical\QA and Quality Systems within small molecule and biologics clinical manufacturing environments. Highly skilled at planning and leading closure of project management activities following FDA 210, 211, 600 and 820 guidelines and developing methodologies and risk based strategies to ensure adherence to Good Manufacturing Processes (GMP). Proven ability to integrate within teams of scientists and engineers. A solid history of building productive relationships with suppliers, CMO’s, CTO’s, employees and management from diverse scientific backgrounds.

Core Competencies

●Biological Products

●Medical Devices

●Protein Chemistry

●GMP/GLP

●Quality Systems

●Regulatory Affairs

●Process Improvement

●Situational Leadership

●Leadership & Mentoring

●e-Publishing

●Document Management

Professional Experience

INDEPENDENT CONSULTING April 2016 – Current

Relypsa, Inc. – Redwood City, CA August 2016 – April 2017

Quality Assurance and Compliance Consultant

Key Achievements:

●Project managed eDMS migration from Pilgrim to OpenText. Acting Relypsa representative to Vifor Pharma for all requests, activities, and managing project to scheduled milestones.

●Project managed Annual Product Report consisting of implementation of new process workflow and template creation for Authors consumption (e.g. Quality Assurance, Quality Control, and Manufacturing).

●Authored SOP for Quality and Compliance Systems, inclusive of Quality Manual, Product Complaints, Annual Product Review, Work Instructions, Excel Spreadsheet SOP

●Managed the corrective action process for observations identified during internal audits, coordinating with interdepartmental stakeholders to resolve observations timely.

●Managed CAPA, Change Controls and Deviations

Audentes Therapeutics – San Francisco, CA June 2016– August 2016

Regulatory Publisher Consultant

Manage day to day submission activities.

Key Achievements:

●Setup and implementation of operational framework for Regulatory

●Technical publisher for the submission of regulatory filings

●Quality Assurance activities including creation and maintenance of company guidelines and procedures. Project manage document review and approval cycle

●Manage submissions in paper and electronic formats and review

●Prepare Submissions: Annual reports, IND and NDA amendments, response to FDA questions, Original IND submissions, Pre-Meeting Background Information, Briefing Package Submissions, etc.

ADC Therapeutics – San Mateo, CA November 2015 – June 2016

Quality and Regulatory Consultant

Key Achievements:

●Project managed on IND filing and assist in authoring CMC sections

●Manage GxP and non-GxP Documentations

●Manage electronic documents on SharePoint (both internal and external third party e-documents)

●Advice on DSUR (Development Safety Update Report)

OncoMed Pharmaceuticals, Inc. – Redwood City, CA January 2011 – April 2016

Regulatory Submission Specialist

Responsibilities:

●Well-versed and experienced with FDA and ICH regulations and processes that govern content and maintenance of controlled documents.

●Owned document management operations across multiple departmental functions, including Regulatory, Clinical, and Quality.

●Responsible for maintenance of all Regulatory, Clinical, Quality and FDA correspondence within specified time frames.

●Responsible for planning, preparing, tracking, and archiving regulatory documents and submissions across multiple formats.

●Project managed with authors on the deliverables

●Supported the development, implementation, and maintenance of document control and record maintenance systems necessary to comply with related domestic and international laws, regulations, and standards.

●Electronic Document Publishing (i.e., scanning, bookmarking/linking, and document verification) as appropriate. Setup Webtrader account and manage all submission to FDA ESG.

●Managed Omnicia consultants responsible for Electronic Submission Systems. Oversight included submission timelines, publishing, and archiving of regulated documents.

●Controlled document format standards through effective liaising with functional source areas (Clinical, Nonclinical, CMC, and Regulatory).

●Effectively collaborated with regulatory document authors to resolve issues and validate documents comply with regulatory and Corporate Guidance/Template Specifications.

Pain Therapeutics, Inc., San Mateo, CA December 2004 – April 2009

Quality Assurance / Senior Document Control Manager

Regulatory Responsibilities:

●Managed electronic files for FDA submissions (IND and NDA).

●Owned document management operations across multiple departmental functions, including Regulatory, Clinical, and Quality.

●Oversight of all paper and electronic files for the company’s first NDA in eCTD format.

●Determined standard practices for business processes which resulted in improved efficiency for the compilation of documents for submissions.

●Prepared and designed templates for Regulatory Affairs (IND, NDA, and Annual Reports).

Quality Assurance Responsibilities:

●Developed and implemented document control system functions, processes and procedures to ensure complete adherence to regulatory agency requirements.

●Designed and enhanced technical documents such as Specifications, SOPs and related Forms in supporting QA, Clinical, and Nonclinical departments.

●Spearheaded the development of a single enterprise portal for all released documents.

●Developed systems and software to integrate work flow for seamless execution.

●Developed processes and provided version control of CMC documents and CMC documents from contract manufacturing organizations. Provided CMC data and batch record review.

●Maintained and managed training files for GxP employees.

●Managed and coordinated the annual review of SOPs.

●Revise SOPs for existing quality system for consistency and compliance with regulatory requirements.

●Manage and monitor corrective and preventive action (CAPA).

●Conducted annual audits to ensure contract manufacturer organizations (CMO) compliance with the Current Good Manufacturing Practice (cGMP) regulations, as well as GLP for packaging and labeling.

●Trained and managed Contractors

Pain Therapeutics, Inc., South San Francisco, CA June 2004 – November 2004

Document Control Specialist (Contractor)

Key Achievements:

●Developed a customized relational database to manage the creation and distribution of controlled documents throughout the Quality Assurance department. This included, but not limited to, the creation of:

oCommercial-Of-The-Shelf (COTS).

oAppropriate databases to track controlled documents for manufacturing, clinical studies, and nonclinical studies as applicable.

oDocument templates and set up document format.

oEstablish document styles and guidance in order to ensure consistency and traceability in both work-in-progress and released documents.

Nektar (formerly known as Inhale), San Carlos, CA July 2000 – November 2003

Systems Specialist

Responsibilities:

●Provided security, managed projects pertaining to Drug Development Research and oversaw IS day-to-day operations to meet NDA filing.

●Defined, documented and measured IT SOPs using FDA standard. Managed licenses, purchase requisitions and billing.

●Trouble-shoot Windows NT/RedHat/Solaris cross-platform networking and BackOffice and desktop support.

●Integrated systems and software for QA/QC.

●Performed maintenance and upgrades.

●Provided technical support to marketing and sales.

●Managed BackOffice PDC/BDC, Network Appliance file servers, backups, SQL database, print servers, Outlook, and IIS.

●Provided networking protocols of DHCP, TCP/IP, NetBEUI, Point-to Point Tunneling, VPN and IPX/SPX Transport.

●Configured and upgraded systems, routers, switches, hubs and multi-media hardware.

●Provided web publications and support.

Genentech Inc., South San Francisco, CA April 1993 – June 2000

Senior Quality Control Analyst

Responsibilities:

●Provided support on quality control computing systems, database administration and backups, QC laboratory systems, system requirements for laboratory instrument automation, and SYNOPSIS implementation.

●Collaborated with internal scientists, consultants and manufacturing engineers to conduct new products research and to implement new product manufacturing.

●Coordinated quality communications between senior management and Total Quality Management team. Lead member in the implementation of new SOPs, training manuals, vendor selection, and manufacturing process changes.

●Responsible for the preparation, submission and administering of regulatory and quality programs to federal, state and industry organizations to comply with FDA, USP/NF, EP, ACS, and cGMP requirements.

●Reviewed and edited manuscripts, analytical protocols and analysis of manufacturing processes, pilot testing, raw-materials inventory and product storage.

●Documented and controlled the release of quality data and product information to regulatory agencies and validation processes.

●Acquired and analyzed both on-line and historical data to statistically validate systems and products in LIMS database.

●Identified and trained others on new computing technologies to enhance QC lab productivity.

●Technical liaison between QC and IS departments.

●Performed statistical analysis for raw materials quality for manufacturing and R&D.

●Expertise included multi-tasking in project management, administrative relations, and analytical instrumentation.

Pacific Environmental Laboratory, Inc., San Francisco, CA February 1991 – March 1993

Quality Management Specialist

Responsibilities:

●Administered the quality program of air, water and wastewater analyses.

●Supervised two analysts in wet chemistry and microbiology on potable water and industrial/municipal wastewater by EPA and Standard methods.

●Duties included internal multiple-sites ISO audits, project management, fieldwork, and inspection liaison.

●Technical duties included sample collection, sample and data analysis, documentation, and client relations for NPDES and SDWA permitting. Analysis included heavy metals, nutrients, salts, pesticides, herbicides, fish killed, BOD, COD, turbidity, Oxygen uptake, and VOCs.

●Specialized in inorganic analysis by microwave digestion for ICP and flame and graphite AAS and organic analysis of pesticides by GC/MS. Relevant techniques include GC with ELCD, FID and PID detectors. Instrumentation responsibility included preventive maintenance, technical communications with vendors, and trouble-shooting and repair.

Certifications/Memberships

1)RAPS – Regulatory Affairs Professionals Society

2)MCP – Microsoft Certified Professional

Educational Background

Bachelor of Science in Biochemistry (1991)

SAN FRANCISCO STATE UNIVERSITY – San Francisco, CA

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