Quality Assurance Project Manager
Resume:
Laura Tarrant
*****.*.*******@*****.***
Pharmaceutical compliance and technical complaint professional with
excellent communication and meeting facilitation skills, translating
strategy into actionable process. Consistently recognized by colleagues and
management for excellence in leadership, process understanding, and cross-
divisional collaboration leading to superior process outcomes and
departmental performance. Areas of expertise:
. detailed understanding of regulatory environment
. quality assurance assessment/KPI/metric development and analysis
. call center management . project management
. Adverse experience (AE) & Product Quality Complaint (PQC)
management
MERCK, Whitehouse Station, NJ
Contact Center Capabilities -
Quality Assurance & Compliance Project Manager
2012-
2013
Develop compliance framework and provide guidance to global contact center
developers/leaders in alignment with Merck strategies. Ensure each new
installation's compliance with Adverse Experience (AE), Product Quality
Complaint (PQC), Privacy and quality assurance requirements and other key
internal policies.
Create Standard Operating Procedure templates for management AE & PQC,
quality assessment process, privacy, audit management and training
activities.
Develop cross-functional metric roll-up process ensuring accurate and
complete statistics cross-divisionally.
2011-2012
AE/PQC Merck lead for US call center operations, ensuring regulatory
compliance, customer engagement and satisfaction levels were met.
Liaise with Merck's external call center vendor management, and internal
Quality, Medical Affairs, Pharmacovigilance and Legal. Call center
generated data consistently met all requirements and reduced compliance
risk as evidenced through quality assessment monitoring process.
Coordinated creation & approval of AE/PQC data collection tools utilized by
call center staff; ensured call efficiency/customer satisfaction and
actionable data for down stream partners.
Developed outbound customer letter and email standards, allowing consistent
output and optimization/strategic utilization of the contact center non-
phone activities.
Subject matter participant for FDA, EMEA, MHRA and internal compliance
unit audits. Developed an audit preparedness process for contact center
operations ensuring staff, operational and document readiness before and
during audit.
Partnered with strategic vendors/new business partners to create
management of AE/PQCs that met contractual and compliance requirements
and eliminated redundancies.
Laura Tarrant Page 2-908-***-**** *****.*.*******@*****.***
Designed and implemented training modules for SOPs and job-specific
training which resulted in subject matter experts at the call center.
MERCK/Schering-Plough Corporation, Springfield, NJ
Global Medical Information - Senior Manager, Customer Quality Contact
Service 2000-2011
Merck/Schering-Plough PQC Intake Integration project lead, creating new
model impacting process, SOPs, computer system enhancement, staffing and
training, quality assurance monitoring. This integration milestone launched
successfully and on schedule.
Manage legacy Schering-Plough compliance-based customer contact group,
designated as the single point of contact for all US prescription and
medical device product quality complaints (PQC). Complaints received via
company 1-800 number and written format.
Manage 8 professional and 1 support staff
Time manage staff operations to successfully meet demands of department 1-
800 number
Develop and conduct PQC training for department including medical
professionals
Assess data and personnel compliance with local and corporate SOPs,
cGMPs and initiate corrective and preventative actions as needed
Create, analyze and report PQC KPIs and metrics
Author local SOP and Work Instructions - recognized as 'gold standard' for
rest of world
Develop Q&A/statements for media noted events ensuring appropriate
complaint management.
Contract reviewer for new business, ensuring inclusion of appropriate
compliance processes
Liaise with internal partner departments ensuring integrated cross-
divisional processes
Create Product Complaint Intake Standard deployed globally.
Integration leader for product quality complaint process and personnel
acquisition of Organon BioScience prescription and medical device products.
Process development with joint venture and third party
partners/manufacturers for complaint intake and recall activities
successfully meeting changing business needs.
Subject matter expert auditee for FDA, EMEA, MHRA and internal compliance
unit audits
Computer System: Analyze and develop computer enhancements for Title 21 CFR
part 11 requirements; system remediation/validation and version update
release; create user requirement documents, verify test outcome results,
update user manual
Laura Tarrant Page 3-908-***-**** *****.*.*******@*****.***
Schering-Plough Corporation, Kenilworth, NJ
Drug Information Services - Senior Consumer Relations Specialist
1994-2000
Designated point of contact via 1-800 number and written communications for
medical professionals, consumers and company personnel for recording and
resolving product quality and user error complaints.
Triage complaint data to investigating departments.
Authorize replacement refund and/or return of product for physicians,
pharmacists and consumers.
Train new employees, including medical professionals on product quality
issues and handling.
Other Experience
Accountancy
Congoleum Corporation, Kearny, NJ
Supervisor, Accounts Payable, Accounts Receivable
Manage function and accuracy of output of the Accounts Payable and
Receivable Departments; supervised staff of 10. Prepared financial
analysis.
Implement online Accounts Payable computer system, system and report
development, staff training, liaison between computer department and senior
accounting personnel, verified accuracy and integrity of on-line testing.
Supervisor, Billing Department
Manage billing function and staff of 12. Tracked sales promotions,
including expenses and revenues generated. Improved departmental operating
procedures in response to sales programming and marketplace needs.
Eliminate unauthorized customer deductions
Staff Accountant
Record cash receipts and inter-company account entries; financial
analysis; banking reconciliations; calculate distributor bonus awards
program.
Education
Montclair State University, B.S. Accounting, Montclair, NJ
Contact this candidate