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adwr59@r.postjobfree.com

CAREER SUMMARY

A highly accomplished, dedicated, and proven achiever with over 40 years of Pharmaceutical Quality Assurance, Quality Control and Quality Management System experience. Demonstrated ability to develop organizations and provide leadership in a changing environment. Possesses proven ability to define problems, develop sound, creative alternatives, implement solutions, and meet aggressive objectives. A “hands on” professional with strong communication, leadership, and team-building skills.

PROFESSIONAL HISTORY

HIREGENICS (BRISTOL MEYERS SQUIBB)

99/2021 to 9/2022

Technical Writer

Responsible for document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement

Perform compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations

Synthesize feedback from SME’s/procedural document teams to identify and resolve issues in order to accurately document current and future processes

Identify, manage, and/or escalate issues and risks to timelines

Exercise sound judgement, using a risk-based approach to ensure compliance with procedural document regulations, practices, and policies

Work with limited guidance to manage the development of global procedural documents and, seek input as needed

VANTAGE CREST CONSULTANTS

14/2017 to 9/2021

Senior Consultant

Responsible for the deployment and implementation of effective and efficient (electronic) Quality Management Systems which include Documentation Management, GMP Training Management, GMP Change Management, Product Quality Complaint Management, Deviation and CAPA Management; and the GMP Management Review System.

Responsible for creating and revising documents with cGMP impact that include Policies, SOP’s, Work Instructions, Specifications, Test Methods and Forms in preparation for PAI.

Assure Quality Management Systems are comprehensive in nature and are compliant with client and relevant health authority requirements.

Develop plans and actions to assure Quality Management Systems are kept current to industry standards and support key client initiatives.

Support FDA cGMP inspections.

OPHTHOTECH Princeton, New Jersey

1 12/2013 to 04/2017

Director, Quality Management Systems

Responsible and accountable for the quality and compliance performance of key global Quality Management Systems including GMP Documentation Management, GMP Change Management; Product Quality Complaint Management; Deviation and CAPA Management; and the GMP Management Review System.

Administer and Direct Company’s training and document control systems.

Ensure appropriate quality oversight mechanisms are in place to provide for effective KPI’s metrics, management review, open communications and proactive issue identification and resolution.

Responsible and accountable for the deployment and implementation of effective and efficient Quality Management Systems at Ophthotech.

Assure Quality Management Systems are comprehensive in nature and are compliant with Ophthotech and relevant health authority requirements.

Lead the implementation of new and/or modification of existing electronic Quality Management Systems.

Assure comprehensive and current validation documentation is in place and maintained to support electronic Quality Management Systems; approves validation documentation as business process owner.

Direct the change management system and resources in compliance with Ophthotech requirements and procedures to ensure an efficient and effective change management system.

Develop, manage, and apply an effective management review program.

Direct the complaint management, deviation and CAPA management systems and processes.

Provide effective Quality leadership during internal and health authority inspections of quality management systems.

Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance of quality management systems.

Serve as a key strategic member of Quality Operations management team by continually assessing quality systems and providing guidance and direction of improvement.

Develop plans and actions to assure Quality Management Systems are kept current to industry standards and support key Ophthotech initiatives.

Plan, develop and administer the annual expense/capital budget for the Quality Management System function and meet agreed spending targets.

SHARP CORPORATION Allentown/Conshohocken, PA

01/2010 to 12/12/2013

(U.S Division of United Drug, Dublin, Ireland)

Sr. Manager, Quality Management Systems

Initiated and directed project to implement Pilgrim SmartSolve (electronic system) investigations, deviations, CAPA’s and customer complaints, across multiple company sites.

Established comprehensive training program using Lotus Notes Training Module.

Process Owner and Project Manager of electronic Documentation and Training Modules.

Supported flawless FDA cGMP inspections resulting in no 483 in 2010 and 2013.

Supported flawless DEA inspections resulting in no findings in 2013.

Supported a flawless MHRA inspection resulting in no findings in 2013.

Manage 24 full-time, 3 temporary and 2 summer interns in the Allentown and Conshohocken facilities.

Manage the Master Packaging Records Department at 2 facilities responsible for the creation of new product MPR’s, revisions of current MPR’s through Change Control, internal approval, customer approval and maintenance and retention of Records.

Manage the Batch Record Review departments at 2 facilities ensuring consistency of Batch Record creation, review, resolution of internal corrections to achieve “Right the First Time” departmental goal for customer satisfaction, timely release of product and shortest possible cash cycle.

Manage Change Control System for 2 facilities, assigning Change Control Numbers, reviewing contents, ensuring information is both accurate and complete, approvals are in a timely manner and customer approval is achieved.

Perform Batch Record prioritization and continuous tracking of records to ensure investigations and deviations are handled in a timely manner to meet our customer’s needs for release and shipment of product.

Manage the Documentation department responsible for the creation, revision, retention, bi-annual review, of cGMP documentation and support of customer audits and regulatory inspections.

Manage the Training department responsible for input of employee training records, notification of outstanding training, retrieval of employee training records during customer audits (2-3 customer audits/week) and support during regulatory agency inspections.

Assist during customer audits providing training records, standard operating procedures, executed Batch Records, Change Control, Validation, Investigations, CAPA’s and as needed.

Facilitated the validation of the Operational Qualification of United Drug’s electronic Quality System, reviewing script execution, resolving issues as needed including exception preparation and providing corporate approvals when a failure existed.

Authored the Performance Qualification scripts for the electronic investigation, deviation, CAPA and customer complaints modules of the packaging division of United Drug.

Executed Performance Qualification scripts at United Drug, Dublin Ireland for Training and Documentation modules for implementation at this division.

Implemented Pilgrim SmartSolve Investigations, Deviations, CAPA, Deviated Material Reports and Customer Complaints at multiple locations.

Authored Investigation, Deviation, Customer Complaints and CAPA Standard Operating Procedures.

System Owner, SmartSolve Investigations, Deviations, CAPA, Deviated Material Reports and Consumer Complaints, Training and Documentation Modules.

Member of United Drug Steering Committee responsible for the planning and development of all phases of Pilgrim Quality System Modules.

Authored Documentation and Training Standard Operating Procedures for SmartDoc/SmartTrain.

Created Roles/Responsibilities Training Matrices for all employees within the organization.

Responsible for providing hands-on training for users in different capacities within the organization.

HALO PHARMACEUTICAL, INC. Whippany, New Jersey

10/2008 to 1/2010

Sr. Manager, Documentation/Training Systems

Supported FDA cGMP inspection resulting in no 483 observations in 2009.

Instrumental in coordinating and driving all the document control activities that were necessary to bring the Whippany, New Jersey site into a state of readiness for FDA inspection.

Designed and executed a Transition Plan for the transition from Abbott to Halo instituting TMS for Halo’s Training Program and developing a documentation program converting existing and creating new documentation to maintain GMP compliance.

Designed, recruited, and developed staff to implement a comprehensive facility documentation system in full compliance with all U.S. Food and Drug Administration (FDA) requirements.

Developed documentation group to accurately respond to regulatory requests. Utilization of an innovative approach to managing the inspection received complements and first pass approval from FDA NJ District Office inspectors. Site compliance status in FACTS changed from VAI to NAI for first time in 5 years.

Responsible for creating, reviewing, revising and approving documents with cGMP impact that include standard operating procedures, work instructions, test methods, protocols, computer system validation and equipment qualification packages.

TUNNELL CONSULTING, King of Prussia, Pennsylvania

Sr. Consultant, Pharmaceutical Quality & Documentation Systems –Sanofi Pasteur

4/2007 to 10/2008

Provided cGMP expertise in the areas of project document development and document management systems with full integration with site and corporate Quality Systems.

Developed and implemented an innovative computerized program enabling document requests, subject matter experts, and all requests to be communicated and recorded in an efficient manner.

Developed a formal, standardized and coordinated process for the control, management, tracking, distribution, and storage of project documentation from conception to licensure/PAI.

Designed and executing a plan for the design, operation, maintenance, and staffing of a centrally coordinated documentation control center.

Developed an innovative communication / database program for use in the PAI war room providing direct contact with the inspection room scribe allowing for timelier and more accurate document and Subject Matter Expert presence in order to comply with FDA requests.

Directly responsible for the cataloging of all PAI documents and the timely fulfillment of FDA documentation requests.

Supported PAI preparation/managed document retrieval.

Developed the processes and procedures (Standard Operating, Work Instructions, etc.) to assure reliability of the origin, state of completion, accuracy, storage and accessibility of all relevant project documentation (including hard-copy and electronic information storage).

EYETECH PHARMACEUTICALS, New York, New York

(A division of OSI Pharmaceuticals as of 14-Nov-05)

3/2002 to 4/2007

Performed in management capacities of increasing responsibility within Eyetech, a start-up biopharmaceutical company specializing in” back of the eye” diseases. Lead compound was a synthetic oligonucleotide designed to bind VEGF Isoform 165 in the treatment of the wet form of age-related macular degeneration. MACUGEN, received FDA fast-track approval December 17, 2004.

Senior Manager, Documentation Systems

4/2004 to 4/2007

Promoted to this position to further develop the documentation department to track and control all cGMP documentation as required by the Food and Drug Administration. Direct supervision of 3 full time employees.

Assumed additional responsibilities when Eyetech merged with OSI in 11/05.

Supported flawless FDA cGMP inspections resulting in no 483s in 2006 and 2007.

Full responsibility for the Quality Management System of the company.

Maintain Regulatory Documentation to fully support Annual Reports, Amendments, Supplements, CBE 30, Prior Approval, other.

Manager, Documentation Systems

3/2002 to 4/2004

Designed, recruited, and developed staff to implement a comprehensive facility documentation system in full compliance with all U.S. Food and Drug Administration (FDA) requirements.

Developed documentation group to accurately respond to regulatory requests. Utilization of an innovative approach to managing the inspection. Received complements and first pass PAI approval from FDA NJ District Office inspectors.

Responsible for creating, reviewing, revising and approving documents with cGMP impact that include standard operating procedures, work instructions, test methods, protocols, computer system validation and equipment qualification packages.

Supported Analytical Research and Development, Quality Control and Quality Assurance in approving documents and systems needed for the NDA application.

Instrumental in coordinating and driving all the document control activities that were necessary to bring the Cedar Knolls site into a state of PAI readiness for the FDA inspection.

Supported a successful PAI in November 2004 which resulted in FDA approval December 2004.

Support regulatory inspections by retrieving and reviewing requested documents and tracking the disposition of documents.

Management/System Owner of the TMS Quality Management System (TMS).

Identify and report training requirements associated with new or revised documents.

Coordinate activities and assist with system validation and equipment qualification.

Trained and managed 3 college interns and 3 full time employees.

ASHLAND SPECIALITY CHEMICALS, Easton, Pennsylvania

3/1998 to 3/2002

Quality Assurance Associate

Performed in the above capacity for this worldwide supplier of specialty chemicals serving industries including pharmaceuticals, adhesives, automotive, composites, metal casting, merchant marine, paint, and paper, plastics, watercraft, and water treatment.

Maintain the company Quality Management documentation system.

Review documentation within review periods and process accordingly.

Maintain current and obsolete quality records.

Ensure all quality procedures are written, reviewed, approved, stored, and archived.

Technical writing of procedures, lab methods and forms as required by QS9000.

Observe processes to create new procedures and audit existing ones.

Create flow charts for Tier 2 procedures as required by QS9000.

Maintain the training database, tracking requirements and training effectiveness.

Coordinate with Environmental Health & Safety MSDS accessibility.

Maintain the software and computer workstations for the MSDS module.

Team leader of Responsible Care to ensure employee training requirements have been fulfilled.

Assisted in the implementation of ISO 9001 in 2000 and QS9000 in 2001.

Performed facility audits ensuring product quality.

INHALON PHARMACEUTICALS, Bethlehem, Pennsylvania

Manager, Facility Documentation

8/1993 to 7/1996

Performed in the above capacity for this start-up manufacturer of generic pharmaceuticals, focused initially on the inhalation anesthetics, enflurane, isoflurane and sevoflurane.

Designed and implemented a comprehensive facility documentation system is full compliance with all U.S. Food and Drug Administration (FDA) and UK Medicines Control Agency (MCA) requirements including Facility Qualification Master Protocols, Validation Protocols, Stability Protocols, Operational Guidelines, Standard Operating Procedures, Test and Inspection Methods, Calibration Procedures, Work Instructions, Site Master File, etc.

Assisted in the development, organization, and submittal of three (3) abbreviated drug applications in less than three (3) months. Obtained approval for all three (3) applications in less than one year.

Successfully negotiated with FDA on submission of annual product reports.

Coordinated labeling specifications and approvals for private label distributors.

Implemented a calibration system monitoring manufacturing, packaging, and laboratory equipment.

Performed yearly review of all cGMP documentation.

Created a documentation system which has sustained the facility for seven years without a 483.

INVACARE CORPORATION, Elyria, Ohio

11/1988 to 8/1993

Quality Supervisor, Returned Goods Group Leader, Quality Control Associate

Performed in the above capacities of increasing responsibility for this industry leader in the $6-billion market for home medical products, manufacturing and distributing the world’s broadest product offering to approximately 15,000 independent home equipment medical equipment (HME) providers.

Developed and supervised a team in a Returned Goods department processing returned goods and tracking quality related issues.

Supervised the daily work activities of four (4) employees focusing on Quality related returns of medical devices.

Participated in team building through a departmental task force to improve product quality and customer satisfaction.

Generated yearly departmental budget.

Represented the company task force in preparation for the Malcolm Baldrige National Quality Award.

ANAQUEST (a Division of British Oxygen Corporation), Cleveland, Ohio

11/1981 to 11/1988

Quality Control Coordinator (11/87-11/88), Quality System Administrator (9/85-11/87)

Quality Department Office Manager (7/84-9/85), Quality Department Administrator (11/81-7/84)

Performed in the above stated capacities of increasing responsibility for this $200+MM manufacturer and marketer of ethical pharmaceuticals, specifically Ethrane® (enflurane), Forane® (isoflurane), Suprane® (desflurane) and Enlon® (edrophonium chloride injection) as well as a bulk supplier of Methoxyflurane, USP.

Collaborated with a contract programmer in developing a preventive maintenance system.

Maintained standard operating procedures for the facility.

Reconciled all manufacturing documentation for the release of final product.

KNOWLEDGE/SKILLS/TRAINING

In depth knowledge of cGxP requirements (includes GMP,GDP, GCP, GLP, GVP) and global health authority regulations with ability to interpret, apply and implement

Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations

Strong negotiating and influencing skills in a matrixed organization

Ability to drive consensus, performance and to lead strategically

High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas

Ability to participate on teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner

Excellent technical writing skills

Expert in MS Office and Collaboration applications

Critical thinking skills in analyzing and exercising judgement on complex issues, guided by a thorough understanding of quality philosophy

Project management concepts, strategies, and skills

Veeva Vault Electronic Quality Management System

Compliance Wire Electronic Data Management System

Pilgrim Electronic Quality Management System

Documentum Electronic Data Management System

Buzzsaw (Engineering Drawing Database)

EDMS, Electronic Data Management System

TMS, Training & Documentation System Database Administrator

Blue Mountain Calibration Manager

Crystal Reports (Report Writer)

TRIM, Training, and Information Management Database

Microsoft Sharepoint

FDA CPG 7356.002, 7356.002A, 7356.002F, 7346.832

Title 21 CFR 210 and 211 and ICH Guidelines

EDUCATION

Lakeland College, Kirtland, Ohio, Business Administration

Northampton Community College, Bethlehem, Pennsylvania, Quality Certification

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