LYNDA A. FRITSCH, MBA270 Cupsaw Dr. Ringwood, NJ 07456

Home: (973)556-5962 - Cell: (201) 988-5560 - lafritsch1@yahoo.com

Professional SummarySuccessful Compliance, Quality Assurance, Risk Management, Auditing professional

with global experience in pharmaceutical and medical device industries. Expert in

Quality & Compliance processes, Exceptional customer service skills, Solution

Delivery, and Operation excellence. Understanding in Project Management

principals, developing positive working partnerships, Goal oriented in advancing

continuous improvement.

Skills Auditing (Internal, External,

Inspection)

Change Management

Operational Excellence &

Continuous Improvement

Quality Assurance

Proficient in Microsoft 365

Suite/Teams, Outlook Exchange,

Webex /Teleconferencing etc.

Project Management

Record Management Risk Management

Strong

Collaboration/Communication

Time Management

Experience01/2009 to Current Digital Officer, Risk Management, Quality & Compliance Sr. Associate

PFIZER - PARSIPPANY, N.J.

Accountable for partnering with Infrastructure Shared Services (SS) and Enterprise

Application teams to ensure services and solution life cycles are planned,

designed, deployed, operated, and supported to meet general controls and

regulatory requirements and follow Business Process Governance.

Responsible for managing third party engagement with clients.

Quality Assurance Maintenance & Approval: Provide support and electronic

approval for all regulated quality systems and processes.

Drive operational excellence by adhering to regulated governing processes such

as; Change Management, Backup and Recovery, Disaster Recovery,

Operational Monitoring, Incident Management, Access Management,

Deviations, CAPAs, Privacy & Security, Periodic reviews, and Training.

Support Internal Corporate Audits: Host and review all GxP and SOX computer

systems and Applications for compliance with applicable Corporate and local

policies/procedures.

Evaluate the design and operating effectiveness of key controls within the Pfizer

Global Data Centers.

Project Management: Engage and consult with teams on projects using ITIL

methodology and solution lifecycle strategies to upgrade and deploy enterprise

solutions, maintain critical applications within a global environment while

remaining compliant and monitor day to day operations.

Support & Expedite Inspection Readiness: Prepare and communicate inspection

readiness programs to all IS Shared Services Infrastructure.

Facilitate the Infrastructure Periodic Reviews.

09/2003 to 12/2008 Infrastructure Operations Specialist

WYETH PHARMACEUTICALS - Pearl River, NY

Process and facilitate all e-protocols for Information Systems (IS) Shared Services

(SS) Infrastructure within a document management system.

Migration and harmonization of the Pearl River IS SS SOP documentation.

Create and maintain IS document database in Access to organize and control

all documentation within Infrastructure & Data Center environment.

Manage and facilitate change control board meetings.

Report weekly metrics and meeting minutes and follow up on open changes.

Conduct Annual Periodic reviews per PR-IS-209.

Support and assist in remedial and corrective action through Trackwise on

periodic review anomalies & action items.

Manage record retention including offsite storage.

Support internal and external audits for FDA Inspections.

Support all IS SS Infrastructure projects as needed.

12/1998 to 02/2003 Quality Assurance Label Administrator & Internal Auditor

STRYKER - MAHWAH, N.J.

Produced, expedited, and managed Stryker's medical device product labels

and change control system to comply with FDA/EU regulations in 12 languages.

Successfully schedule, execute internal audits within Manufacturing.

Education05/2014 Online course - Drug Development:

Temple University - Philadelphia, PA

Introduction to Drug Development

05/2011 MBA: Business Management

Iona College - New Rochelle, NY

Minor in E-Commerce.

05/2003 Bachelor's Degree: Organization Management

Felician College - Rutherford, New Jersey

Degree in Organization Management

05/1996 Associates Degree: Business Administration and Accounting

Fairleigh Dickinson University - Rutherford, NJ

Studied Liberal Arts, Minor in Accounting

Certifications Technical Institute of America Project Management Professional (PMP)

Certificate, In -Progress (2019)

Toastmasters International Competent Communicator Certificate (CC) (2018)

GMPCP - Good Manufacturing Practices Certified Professional (2011)

Information Technology Infrastructure Library v3.0 (ITIL), Certified (2010)

OSHA 10-hour Outreach Training for General Industry Certificate of

Completion (2010)

COBIT Foundation V4.0 Certified (2009)

ISO9000 Quality Auditor / Lead Certificate (1999)

AffiliationsToastmaster International leadership volunteer roles; Sergeant In Arms officer served

1 year ( 2018-2019); Recently elected Vice President of Education Officer VPE, (2019-

2020); Healthcare Businesswomen's Association (HBA) Member since (2016); IONA

Alumni Member (2011); Volunteer for Running the Computer Database System and

Treasurer of the Bergen County Outreach Auction Annual Event (2002 - 2018);

American Society of Quality (ASQ), Member since (1998)