PROFICIENCIES AND COMPETENCIES
- Quality Systems Subject Matter Expert
- Leading On-site Quality Inspections and Audits
- Implementing Policies and Guidelines
- Technical Writing
- Business Analysis/Process Improvement
- Root Cause Analysis
- Investigating and Resolving Quality Events
- Collaborating with Regulatory Agencies
- Leading Gap Analysis and Remediation
- Develops and Leads Staff Quality Training
- Change Management
- CMO Management
- Corrective and Preventive Actions (CAPA)
- Risk Management
- Management, Training, & Coaching Skills
- ISO 13485 / 21CFR part 820/21 CFR 210/11
2012 TO PRESENT: INDUSTRY CONSULTANT
Fulfills a key role providing guidance and direction to a diverse roster of clients. CXC provides dynamic Quality Assurance, Regulatory Affairs and Project Management services to Pharmaceutical, Medical Device, Biotechnology, Clinical Operations and associated industries. Key client engagements include:
CONFIDENTIAL, QUALITY LEAD
APR 2019 TO PRESENT: MA
Retained by a phase 2/3 clinical stage organization developing novel class therapies as a quality leader. Responsible for providing organizational management and leadership for all Quality Assurance activities ensuring cGCP compliance. Work collaboratively and cross-functionally with the Manufacturing, Supply Chain, Technical Development and Clinical teams, among others to ensure compliance with and improvements to Quality Management System.
- Developed and implemented Quality KPI’s aligned with business objectives and communicate progress to the broader organization.
- Provided solutions, guidance and oversight to Quality organization that are both compliant and in alignment with internal standards and goals.
- Developed, reviewed and approved Standard Operating Procedures (SOPs), Change Controls, Validation Protocols/Reports, and identify compliance gaps and proactively take steps to remediate, ensuring internal and external standards are met.
- Assist in the review of documents and data submitted in or in support of regulatory submissions.
- Conduct Quality review of internal and external production documentation, including batch records, analytical records and any supporting documentation to ensure compliance with cGMP and internal policies and procedures.
- Provide Quality Assurance oversight in support of product development and in-process, release and stability testing of raw materials, drug substance, and drug product.
- Provide QA support for qualification of manufacturing activities.
- Proactively identify compliance issues, investigate and propose solutions, and lead closure of deviations and completion of corrective and/or preventative actions.
- Perform day-to-day activities of Document Control including creation and/or revision, processing, routing, and releasing controlled documents.
- Responsible for leading the planning, execution and close-out audit work plans including effectiveness checks and issue escalation.
- Perform Quality audits of contract organizations including manufacturers, laboratories, and suppliers.
ALEXION PHARMACEUTICALS, QUALITY SYSTEMS CONSULTANT (QUALITY MANAGEMENT SYSTEM CHANGE LEADER)
MAY 2018 TO MAR 2019: MA
Supported the Quality Management System (QMS) process harmonization effort across: Change control, Document Management, Vendor Management, Training, Deviation / CAPA, Audit, Clinical Operations and Inspection. Utilized business analysis, operational management and process improvement acumen for developing and implementing Quality System Elements (QSE) process standardization, implementation and “go forward state.”
- Supported all Business Process Owners (BPO) harmonization efforts providing timely content, QMS architecture (process and end to end mapping) and support of overall program objectives and strategies.
- Partnered with senior leadership to drive maintenance and continuous improvement of critical business areas of the QMS from quality policy through procedures and training. Established Centers of Excellence for event management and training.
- Provided and ensured change management was incorporated and effective methodology into QSE plans and overall program management.
- Developed metrics for future state QSE elements and overall program change impact assessment reporting.
- Project realized a reduction of 26% of business process SOPs and training time. Streamlined processes reduced risk of conflicting compliance requirements with a projected reduction of 18% of deviations and CAPAs.
JANSSEN PHARMACEUTICALS, QUALITY SYSTEMS CONSULTANT (QUALITY MANAGEMENT SYSTEM LEADER)
SEP 2017 TO APR 2018: NJ
Independently carried out development and implementation of the BioResearch Quality and Compliance clinical sector’s Quality Management System (QMS). Tasked with developing and implementing phase appropriate processes to navigate the sector through the product lifecycle in adherence to GxP regulations and guidance.
- Mapped quality and compliance capacities and systems to build out an umbrella Quality System (quality manual) document to provide framework and demonstrate quality system effectiveness.
- Developed and authored umbrella Quality System document providing streamlined visibility to quality and business processes ensuring the elements of the QMS are wholistic to support R&D quality and compliance needs.
- Provided strong guidance, interpretation and information pertaining to cGMPs, GCPs and GLPs to apply updates to the Quality System including policies, SOPs and specifications.
- Responsible to develop a systemic, risk focused and balanced approach to clinical operations to evaluate and improve effectiveness and efficacy of internal controls and governance process.
MERCK, QUALITY SYSTEMS CONSULTANT (DESIGN HISTORY FILE REMEDIATION)
OCT 2016 TO JUL 2017: NJ
Directly responsible for ensuring that all required technical documentation of legacy combination products comply with company and regulatory standards (820 and 21 CFR Part 4) through demonstrated understanding of medical device regulations and best practices.
- Reviewed and assessed DHF files and/or associated documentation for compliance gaps from formative testing of early prototypes through final design.
- Executed remediation of DHF files for dispensing tubes, metered dose inhalers, auto injectors, pens and prefilled syringes combo products within product portfolios.
- Updated and developed all associated documentation related to DHFs including all elements of design control and associated design changes.
- Coordinated documentation activities with other functional groups including design development, regulatory, clinical and quality assurance.
- Developed retrospective analysis to support the continued marketing of combination products.
ETEX (ZIMMER BIOMET), QUALITY SYSTEMS CONSULTANT (CAPA REMEDIATION)
JUL 2016 TO DEC 2016: MA
Provided leadership and technical support for the Corrective and Preventative Action process. Key contributor to cross functional and problem solving teams as CAPA coach and reviewer. Ensured compliance to regulatory requirements, company policies and procedures for the CAPA system.
- Served as hands on contributor and mentor for the CAPA process across all business processes.
- Supported Quality Management by ensuring preventative and corrective actions were issued as required, properly investigated, documented, effective and completed on time.
- Provided proper training to improve investigations for determination of an effective action plan.
- Identified and led implementation of new opportunities for improvement to work processes, production and other areas identified.
MERCK, QUALITY SYSTEMS CONSULTANT (INVESTIGATION SPECIALIST)
MAY 2016 TO JUN 2016: PA
Responsible for activities related to the investigations/deviations/CAPA process for the aseptic vaccine manufacturing facilities.
- Conducting the investigation, writing summary reports, suggesting and implementing appropriate corrective actions and verifying effectiveness of CAPA.
- Wrote deviations related to manufacturing, packaging, warehouse, facilitates and engineering.
- Conducted Root Cause Analysis to evaluate each of the possible causes to determine true root cause and provide consistency across investigations.
- Proposed, reviewed and/or implemented appropriate corrective actions and preventative actions based on investigations. Developed and tracked investigation/CAPA metrics for management review and periodic reporting and trending.
JANSSEN DIAGNOSTICS, QUALITY SYSTEMS CONSULTANT (QUALITY COMPLIANCE PROGRAM LEADER)
AUG 2014 TO JUL 2016: NJ
Retained by this research-based IVD biotechnology company to build effective working relationships with scientific, manufacturing and quality staff across US and European sites to enhance a culture of quality and continuous improvement. Authored governance policies that will guide the global deployment of an improved Quality Management System that will cover all facets of production, validation, training, master batch records, and other business critical areas. Led assessments of all high level procedures to identify gaps and areas requiring improvement while measuring compliance with company enterprise standards.
- Provided leadership and vision for the development of compliance and quality measures derived from ongoing continuous improvement initiatives.
- Developed tools to deploy solutions to meet strategic objectives around business objective and regulatory compliance.
- Rationalized and remediate quality system and procedural documentation for multiple client locations.
- Developed KPIs and trend analysis for roll up to oversight functions.
- Assist with training and deployment of updated procedures.
- Quality and validation strategy and planning – Quality lead on client project team. Define quality and validation requirements, activities, resource requirements and plan to support opening of new laboratory facility.
- Quality and validation execution – Quality lead on client project team. Execute the validation requirements and activities to support the opening of new laboratory facility. Review and provide quality approval on validation protocols, executed protocols and other project deliverables. Develop document inventories for product DHF records.
PRECISE PACKAGING, QUALITY SYSTEMS CONSULTANT, LEAD AUDITOR
MAY 2014 TO AUG 2014: MA
Tasked to review and lead the response to issues defined in an FDA Form 483 letter, engaging in the design and implementation of quality system programs across all business units for this producer of OTC medications. Collaborated extensively with senior leaders to provide guidance on audit observations, corrective actions, and compliance deviations, establishing a framework to support a positive and proactive approach to regulatory compliance going forward. Efforts were implemented to increase customer base and revenues based on compliance with ISO standards that were a prerequisite to certification. Project goal was to verify and document client’s overall effectiveness related to regulatory mandates and internal compliance standards.
- Analyzed information relevant to audit objectives including interfaces between functions, activities and processes.
- Reviewed regulations, standards, procedures, records, and data.
- Performed cause analysis and identified linkages to business objectives for effective corrective action plans.
- Delivered full assessment and comprehensive and actionable remediation plan.
MAQUET, QUALITY SYSTEMS CONSULTANT (POST MARKET SURVEILLANCE PROCESS LEAD)
DEC 2013 TO MAR 2014: NJ
Led Remediation of Quality System Investigations including Retrospective Analysis of Existing Investigations, Generation of Supplements as needed to remediate, and training and coaching of Quality Staff on requirements for a comprehensive investigation.
- Provided guidance and supervision to the Global Complaint Handling department.
- Managed customer complaints in support of Cardiovascular disposables and Cardiopulmonary hardware
- Managed the escalation of complaints that may lead to reportable events.
- Worked with the Field Service Organization and various manufacturing facilities to ensure the complaint handling process was operating in a compliant manner.
- Provided complaint trending reports and analysis to feed into the management review process and FDA.
- Identified complaint trends that support the CAPA process, vendor management and continuous improvement efforts.
- Facilitated and documented health hazard assessments, and conducted post market surveillance reviews to support product risk evaluations.
- Developed and conducted training for employees on the complaint handling process.
- Demonstrated capacity of functioning effectively in dynamic, deadline-driven, fast paced environment.
NOVARTIS, QUALITY SYSTEMS CONSULTANT (APQR)
JUN 2013 TO DEC 2013: TOR, CANADA
Successfully prepared and produced Annual Product Review (APR) Reports for branded and third-party products to address a Health Canada audit finding for the Toronto, CAN site.
- Contributed to all activities associated with Annual Product Review process.
- Prepared Annual Product Review Reports for marketed products and third party products in accordance with global company and country specific regulations.
- Collaborated with the APR remediation team, reviewers and approvers to identify issues and gaps related to APR process.
- Provided training and coaching to APR team to resolve process issues and streamline process flow.
- Identified areas of improvement in the APR process for the site Senior Leadership and provided coaching and mentoring.
- Worked with APR area SMEs and their management to remediate any gaps identified in the APR.
- Educated cross functional teams about their roles and responsibilities.
- Participated in, led, and/or coordinated meetings related to the APR remediation process and project metrics
- Authored and updated relevant SOPs.
HOSPIRA, QUALITY SYSTEMS CONSULTANT (FIELD ALERT REPORTING, COMPLAINT INVESTIGATOR)
MAR 2013 TO MAY 2013: TX
Directly responsible the review, submission, and follow-up of investigation and closure activities associated with over 500 Field Alert Reports for aseptic manufacturer, engaging in the investigation of root causes of defects for items returned from the field. Examined batch records, reviewed release documentation, and assigned testing based on risk categories and defect types to drive complaint closure.
- Authored and reviewed initial, follow up and final Filed Action Reports for regulatory submission.
- Initiated investigation and identification of the root cause for defects returned from the field including batch record and SOP review, assigned testing based on defect type and risk category.
- Assisted in developing an effective corrective action that ensured product quality and best practices.
- Analyzed complaint data to identify unfavorable trends and recommend improvements to management.
- Participated in projects related to remediating repetitive complaints.
- Guided Manufacturing, Engineering and Corporate subject matter experts to drive to root cause of investigations and reviewer for closure.
- Participated in CAPA process; including, collecting and analyzing data to appropriately and efficiently identify ‘Root Cause’ and ensuring ‘Verification of Effectiveness’ plans are comprehensive, to facilitate overall improvement in performance of key quality system elements, monitor metrics for determining the effectiveness of applicable quality systems, develop processes and plans to address improvements as identified.
LANTHEUS MEDICAL IMAGING, QUALITY SYSTEM CONSULTANT (APR, CAPA, VENDOR MANAGEMENT)
JUL 2012 TO MAR 2013: MA
Effectively managed the production of the Annual Product Review Report for aseptic manufacturer of diagnostic imaging agents, collecting and assembling data regarding stability, complaints, change control, and deviations from multiple departments to build recommendations for the improvement of processes and oversight.
- Responsible for the preparation of the Annual Product Review Report according to the established schedule
- Compiled data from cross functional departments (e.g., stability, complaints, change control, deviations); interpreted analytical test results; summarized data from departments and made recommendations for product/process improvements.
- Ensure information included in the APR was current and accurate.
- Prepared Annual Product Review and GMP metric trends for submission.
- Developed and coordinated implementation of quality systems, procedures and test methods for existing and new products in compliance with QMS.
- Led projects related to complaint investigations, CAPA and quality systems.
- Mentored CAPA program, guided implementation of global CAPA policies and CAPA effectiveness reviews.
- Reviewed and approved validation test protocols and final reports; reviewed and analyzed data contained in the validation test reports to insure compliance with protocol test procedures and specifications; evaluates deviations which occur during the validation test process.
- Provided technical expertise and QA approval of raw material, process/equipment and analytical methods validation protocols.
- Reviewed and approved Validation Master Plans, validation protocols and finished reports ensuring compliance with cGMP regulations and internal standards.
- Provided direct QA support of programs, including Material Review Board, Investigational Review Board, Environmental Action Committee and participated as a Change Control Board (CCB) member.
GENZYME, QUALITY SYSTEM CONSULTANT (QUALITY OPERATIONS)
SEPT 2010 TO JUL 2012: MA
Supported GMP compliance and product disposition of drug substance, drug product and finished product (parenterals) manufactured internally or by CMOs. Key supporter of Quality System compliance and oversight, processes including deviations, change controls and CAPAs.
- Developed and maintained quality assurance systems and activities.
- Reviewed Batch Records and disposition activities for drug substance, drug product and finished products (parenteral).
- Conducted audits to support internal audit program.
- Generated documents used in GMP activities such as release/stability data, analytical methods, COAs, quality agreements, specifications, quality events and change controls.
- Reviewed and approved manufacturing/analytical OOS and nonconformances.
- Demonstrated consistent and disciplined execution of the execution of the investigations workstream ensuring completeness and comprehension of the investigations while determining most probable root cause.
- Wrote quality events, conducted root cause analysis sessions to drive consistent execution for closure by interacting with necessary departments to get the job done
- Identified and tracked Key Process Indicators (KPIs) for reporting of quality metrics.
- Performed data verification and approval of CMC related reports.
- Drafted and revised SOPs as needed.
VERTEX PHARMACEUTICALS, QUALITY ASSURANCE CONSULTANT (QUALITY OPERATIONS)
APR 2010 TO SEP 2010: MA
Quality Consultant retained to provide support as clinical change control champion and batch record review through support of GMP quality compliance matters.
- Oversaw the change control program as global quality system representative.
- Served as champion for the change control program ensuring alignment of SMEs and key stakeholders and initiate and facilitate resolutions of issues.
- Served on Change Review Board.
- Responsible for developing and mentoring staff for process and operational excellence.
- Collaborated with internal and external departments on strategy and implementation of quality principles and provide feedback and insights as required.
- Provided ongoing improvement ideas for the process and system improvements under the direction of the Global Quality Director.
- Reviewed and approved CMO executed batch records for completeness and accuracy.
- Co-reviewed deviations, change controls and CAPAs related to commercial products.
- Supported CMOs in developing and executing remediation actions.
Director, Quality Management Systems, Integra Signature Technologies (IntegraLife Sciences), MA 2004-2009
- Accountable and responsible for strategic leadership, management and direction of QMS while developing organizational structure, talent and resources aligned with key QMS imperatives and delivering results.
Quality Operations Site Lead, Bari & Gail Chocolates (OTC), MA 2001-2004
- Developed, implemented and management of QMS content to align with strategic goals and delivery of quality outcomes.
Senior Scientist, Specialized Technical Resources, CT 2000-2001
- Responsible for providing technical leadership in laboratory programs for drug substance from clinical to commercial filings. Primary responsibility included analytical method development and validation for process and product characterization for clinical and marketed drug product.
Associate Director, Global Quality Management Systems and Training, Medtronic, NJ 1994-2000
- Responsibility for governance activities for global QMS while collaborating with process owners to ensure global QMS documentation aligns with QMS architecture and quality standards.
BA in Biology – SAINT ANSELM COLLEGE