Shylla T. Haskins

Newark, DE ***** ? (C) 302-***-**** ? acd6so@r.postjobfree.com

QA and Compliance Director

Distinguished career driving best practice-based quality improvements in

the pharmaceuticals and medical device industry

Strategically-focused, action-oriented Associate Director with 19 years of

experience ensuring quality and compliance across product release, product

complaint, manufacturing, and clinical processing for pharmaceutical and

medical device products and processes. Expertise managing within QA/QC

practices in collaboration with external Contract Manufacturing

Organizations (CMO) and external Contract Testing Laboratories (CTL)

leveraging cGMP and cGMP best practices. Organizational strategist for

defining and prioritizing future quality and process initiatives.

Demonstrated effectiveness creating governance practices aligned with FDA

and European regulatory agency requirements including controls for DEA

regulated products. Repeated successes creating measurable gains to

production controls, profitability, and manufacturing efficiency. Expertise

designing and executing training programs that enhance staff knowledge and

performance as organizational SME for QA/QC issues. Skilled manager,

trainer, and mentor to junior staff.

Technical & Leadership Strengths:

Pharmaceuticals Manufacturing Process Auditing Strategic Planning

Project Management FDA Regulatory Compliance

Policy & Procedure Team Building

Development Performance Metrics Relationship Management

Strategy Development Change Management Team Management

Lean & GMP Best Practices Knowledge Management Staff Development

Continuing Process Training Program Creation

Improvement

Product Complaint Management

Career Highlights

< Identified and implemented supply chain improvements that saved $11.7

million.

< Spearheaded needs assessment, evaluation, and selection of new

document management system across Newark DE, Wilmington, DE, and

Westborough, MA sites. Directed selection and implementation of

Technical Document Management System (TDMS) that standardized

Operations, QA/QC knowledge management, and communications across the

business.

< Led organizational change control process improvement project

leveraging Lean and project management-based best practices.

Streamlined execution and improved communication sites while reducing

administrative inputs across all three sites.

Professional Experience

Terumo Cardiovascular Group, Elkton, MD

Development, manufacturing and distribution of medical devices for cardiac

and vascular surgery with an emphasis on cardiopulmonary bypass, intra-

operative monitoring and vascular grafting.

( Director, Quality and Compliance (2013-present)

Responsible for the management of the Quality System at the Elkton

location. Accountable for overall quality oversight for both site produced

products and third party distributed products. Develops and maintains

quality policies, procedures and controls to ensure compliance with ISO and

FDA guidelines and standards. Serves as Management Representative for all

regulatory and certifying bodies during audits and inspections. Direct

Quality Unit of over 50 associates including Product Complaints, Product

Quality, Documentation Control, Quality Engineering, Quality

Compliance/Systems, Internal and External Auditing, New Product

Introductions, and Validation/Qualification activities.

Selected Contributions:

< Successfully managed all aspects of quality for Elkton produced and in

licensed distributed product.

< Directly contributed to 30% efficiency gain in Non-Conformance Closure

rate by re-organization of process and re-defining accountabilities

and responsibilities.

< Successfully strategized and re-organized quality function to meet

both current and future business needs .

< Successfully contributed to re-engineering of risk and severity

ranking for a compliant and cohesive Risk Management program.

< Successfully directed CAPA, corrective and preventative action

programs to ensure compliance and improve.

< Successfully improved and sustained product complaint closure rates.

Improved quality of complaint documentation in support of regulation

requirements. Directly improved customer response process and

documentation via work with Clinicians, Legal and Sales/Marketing.

< Successfully directed and implemented improvements to MDR management

(Medical Device Reports) to ensure compliance with regulations and

required time commitments.

< Redeveloped Health Hazard Evaluation investigations to include

procedural outlines and directive to improve compliance and

efficiencies.

< Improved collaborative efforts amongst Distributed Product Partners.

< Successfully directed and managed recall and reconciliation activities

with Regulatory bodies, senior leadership and site personnel.

ENDO Pharmaceuticals, Malvern, PA

Focused on creating high-value branded products that meet the unmet needs

of patients along care pathways for pain, urology, oncology, and

endocrinology.

( Associate Director - QA External Manufacturing (2012-2013)

Responsible for the quality management and release of all product (branded

and generic) manufactured and produced at CMOs/Third party (Approximate 45

sites). Accountable for overall quality oversight for ENDO manufactured

products including Active Pharmaceutical Ingredients (APIs), solid dosage

tablets, injectable vials, oral contraceptives (OCs), and Over the Counter

(OTCs). Develops and maintains quality policies, processes, procedures and

controls ensuring that the quality of products conform to established

standards and regulatory requirements and guidelines. QA SME for

Analytical, Stability and Product Complaints. Provides guidance in the

interpretation of CFR guidelines and internal policies and procedures

ensuring compliance. Conducts for cause and due diligence audits of

suppliers and vendors.

Selected Contributions:

< Successfully managed all aspects of quality release for all ENDO

products, APIs and intermediates.

< Successfully drove continuing evolution of quality best practices for

CMO QA oversight process.

< Successfully managed the transition of QA activities from Westbury, NY

location to Malvern, PA in a seamless and cohesive manner without

interruption to the business.

< Re-developed assessment activities associated with CMO performance to

ensure proactive compliance. Redeveloped KPIs to assist in quality

monitoring.

< Successfully improved QA relationships between ENDO and Contract

Manufacturing Organizations

< Developed and administered Quality Technical Agreements ensuring

strict compliance with terms of service.

< Management of all Quality areas including QA External Manufacturing,

off-site QA Distribution, Change Management and Documentation, and

Product Complaint Handling.

< Responsible for quality content for Field Alert and other regulatory

documentation submittals

< Successfully launched new product/presentations to the market.

Auxilium Pharmaceuticals, Malvern, PA

A provider of innovative solutions for unique diseases that improve health

and quality of life.

( Senior Manager - Corporate Quality Compliance (2011-2012)

Manage Auxilium internal and external audit program. Support development

and execution of quality and compliance activities including clinical

testing, scale-up, manufacturing, and release. Ensure full compliance with

federal and state regulatory requirements and requirements and cGMP / cGXP

best practices for contract manufacturing (CMO), external contract testing

labs (CTL) and suppliers. Steer quality operations at all Auxilium internal

and external sites. Facilitate partnering between commercial, clinical,

and manufacturing facilities via review, approval, deviations

investigations, and OOS. Manage quality agreements and, vendor

qualifications, annual product reviews, change controls, and corrective

actions.

Selected Contributions:

< Successfully drove continuing evolution of internal and external audit

program aligned with QA auditing requirements.

< Managed Inspection readiness process for Auxilium for FDA, EU,

Canadian Regulatory authorities, and other ROW partners.

< Management of Product Complaint Process including product

investigation and followup.

< Re-developed vendor qualification processes and strategy to integrate

regulatory and quality standards changes.

< Developed and administered Quality Technical Agreements ensuring

strict compliance with terms of service.

< Maintain SME (Subject Matter Expert) program for all areas

( Senior Manager - Quality Assurance (External Contract Manufacturing)

(2009-2011)

Guided QA team tasked with review, approval, and release of products,

physician samples, and patient assistance products including DEA controlled

materials manufactured at CMOs. Facilitated interactions between CMO and

CTL groups, and contracted third party providers for all QA/QC activities.

Managed deviation/investigation,CAPA and complaints processes. Teamed

with operational management including regulatory and manufacturing groups

for ongoing process improvement. Collaborated with FDA and European

regulatory agencies for internal / external audits and site inspections.

Developed Quarterly Training Reports and Annual Product Reviews.

Administered organizational change.

Selected Contributions:

< Developed, implemented, and refined QA/QC KPIs. Proactively monitored

targets resulting in organization routinely exceeding performance

goals.

< Enhanced deviation and investigation processes that raised

expectations and fostered improved collaboration between Auxilium and

third-party providers.

< Hosted quarterly QA meetings with CMO as forum for incremental process

improvement.

< Served as "go-to" resource for QA issues across testing including

stability and validation.

AstraZeneca Pharmaceuticals, Newark, DE

A world leader in improving health and quality of life through innovation

in medicine.

( Senior Manager - QA Change Control and Documentation (2005-2008)

(Training Leader for Training Systems 2006-2007)

Directed development of multi-term strategies, processes, administrative

policies, and technologies governing business critical QA/QC document

control, archiving, and procedural improvement practices. Guided ongoing

assessment, improvement, and execution of quality document enhancement and

improvement projects aligned with Lean manufacturing best practices and FDA

regulations.

Led interdisciplinary teams from Supply Chain Management, Operations,

Planning, Engineering, and FDA through KPI and performance metrics

development initiatives. Conducted process audits and drove remediation

projects; served as primary liaison to FDA auditors. Managed organizational

change including due diligence with executive and functional managers.

Deliver periodic reporting to strategic leadership and serve as

organizational QA subject matter expert (SME). Recruited, hired, train,

mentored, and evaluated professional staff of ten members.

Selected Contributions:

< Provided strategic guidance for training program overhaul based on

Good Manufacturing Practices (GMP). Led team that evaluated, selected,

and implemented Plateau Learning Management Systems (LMS).

< Steered organizational policy standardization for Master Plans,

Production Product Plans, FDA Regulatory Compliance documentation,

Policies, SOPs and Clinical Studies and Processes. Oversaw

administration of the QA body of knowledge ensuring currency and

accuracy between Delaware and Massachusetts facilities.

< Designated change request authors that reduced submitters from 400 to

30. Assigned corresponding business process owners that served as

designated change control managers.

< Drove development of real-time KPI dashboard leveraging untapped

capabilities of existing management reporting system. Provided

unprecedented levels of project tracking, reporting, and control for

success rates, timetables, and integrity of throughput.

( Senior Manager - QA Product Certification (2002-2005)

Managed up to ten staff engaged in process improvement projects impacting

QA and Supply Chain Operations. Teamed with executives and senior managers

to identify, plan, and execute QA process and policy changes through the

full project life cycle aligned with GMP and FDA best practices. Identified

gaps and improvement opportunities; developed remediation strategies and

presented detailed proposals to executive decision makers as part of

continuing process improvement. Addressed Product Complaints and oversaw

Annual Product Reviews. Served as SME to FDA for investigations and

justifications. Managed QA Certification group tasked with approving

product documentation, reviewing and approving raw materials, and

evaluating external contractors. Managed the product complaint and

investigation process.

Selected Contributions:

< Reduced product release from 7 to 2 days by restructuring ownership

based on business line. Sustained over 97% on time release rates.

< Steered development of Batch Records Tracking System (BRTS) that

provided product status tracking.

< Provided strategic direction for addressing product quality issues as

member of Quality Deviation Committee.

< Justified production decisioning to FDA for quality issue requiring

production stoppage. Presented detailed resolution process detailing

action, timetables, ability to re-enter marketplace, and remedial

quality steps that enabled production resumption in less than two

weeks.

( Manager - QA Product Certification (2001-2002)

Served as QA representative to new product launch teams; provided guidance

for embedding QA practices into all phases of planning, execution, and

control. Managed end-of-year Work in Process (WIP) efforts ensuring

expedited completion for projects with $58 million in committed materials.

Selected Projects & Achievements:

< Provided integral guidance to on time launch of Seroquel, Arimidex,

and Crestor product lines.

< Developed, implemented, and administered QA Certification program that

equalized practices across the enterprise.

< Led QA team efforts during logistics management system migration

legacy system to SAP. Trained staff, piloted system, and completed

all key deliverables prior to all other business units.

~ Prior experience (1994- 2001) as QA Certification Specialist, Operations

Supervisor, and Process Engineer with AstraZeneca Pharmaceuticals ~

Education & Credentials

Master of Business Administration (MBA)

Wilmington University, Wilmington, DE. Graduated with Honors

Bachelor of Science in Chemical Engineering

North Carolina A&T State University, Greensboro, NC. Graduated with Honors

Professional Development

Emerging Leadership ~ Working Smarter ~ Emotional Intelligence ~

Transportation Management ~ Logistics Management ~ Hiring & High Ethical

Standards ~

Memberships & Affiliations

Member ? American Society for Quality

Member ? Parental Drug Association

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