SUMMARY:

• Eighteen years of Quality Assurance experience supporting cGMP, GLP and GCP compliance projects for medical device, pharmaceutical, biologics and combination products. Expertise working with national (FDA) and international (MHRA, EMA, TGA) requirements as well as ISO and ICH policies
• Experience managing direct reports of small to midsize teams
• Experience with regulatory inspections (face to face interaction with agents) and previous ASQ and RABQSA as lead quality auditor. Over 100 national and international audits conducted as lead auditor
• Trained Software Validation Analyst (AAMI software validation per FDA’s General Principles of Software Validation)
• Excellent oral and written communication skills in English and Spanish
• Internal & External Audits
• Process Performance Metrics Development & Implementation
• Quality Systems Management
• DoE, FMEA & FMECA
• Policies/SOP/Standards Development & Implementation
• MRB investigations leading to Deviations, NCR and/or CAPA
• Risk Management & Planning
• Supplier Qualification & Lifecycle Management
• & Development
• Technical Writing
• Master Validation Plan & Reports (IQ, OQ, PQ)
• Complaint Management
• Software Development and Lifecycle Management (Rev control, Requirements Matrix, Test Scripts)
• Global senior leadership experience leading teams of up to 20 direct reports throughout 3 continents
• Compliance leader with expertise in national (FDA, 21 CFR parts 11, 310, 820) and international (European Union EU MDD 93/42 ECC, 93/68 ECC, 2002/83 ECC, Canadian CMDR SOR 98 - 282) regulatory requirements as well as harmonized guidance (ICH Q5A, Q7, Q8 and Q10) and ISO 13485/ISO 14971 standards
• Lead Auditor for over 100 national and international internal and external audits to select and monitor suppliers, contract manufacturing sites and testing labs
• Quality management representative/ Wo man on plant with responsibilities as first line of contact in the event of planned/unplanned external and regulatory audits
• Developed and established phase appropriate QMS (policies/standards, procedures, WI, Forms, OJT and metrics) for Fortune 500 companies as well as small start-ups
• Experience working with aseptic filling processes and post production sterilization methods
• Experience working with a variety of drug delivery methods such as but not limited to oral small molecule dosages (tablet encapsulation), parenteral devices (pre-filled syringes), long term & short term implantables (heart stents, osmotic pumps & orthopedic prosthesis)
• Experience working with a variety of medical devices such as but not limited to orthopedic implatables (investment casting of metals), longer term implatables (stents & osmotic pumps), short term implantables (osmotic pumps & balloon catheters), lasers and diagnostics
• Managed CMO’s deviations, investigations and CAPA, and their escalation to sponsor’s QMS as applicable, in preparation for clinical material release
• Performed qualification, for-cause and investigational audits of CMOs
• Coordinated QP audits of CMOs
• Developed, documented and maintained phase appropriate standard operating procedures (SOP) to ensure the quality of investigational products conformed to applicable regulatory requirements
• Contributed to the design and approval of clinical study materials such as inform consent forms, investigational brochure (IB) and study master file
• Responsible for the release and disposition of investigational product
• Developed, documented and maintained phase appropriate processes to ensure the quality of investigational products conform to applicable regulatory requirements
• Provided guidance, oversight, and direction to outsourced operations at contract manufacturers and contract laboratories
• Worked closely with cross-functional teams (Product Development, Clinical, Regulatory Affairs and Pharmacovigilance) to provide leadership and support of preclinical development of investigational product
• Worked closely with Qualified Person (QP) to ensure investigational product technical file contained all data required for EU material release
• Led various QMS remediation projects throughout Pharma, Biotech and Medical Device industries to satisfy FDA sanctions associated with CAPA, change management, complaints management, purchasing controls, Mfg. controls, QTA, supplier management, materials management and process validation
• Capable of implementing operational excellence tools/methodologies (Lean/HPMS) to improve the QMS of large Fortune 500 company as well as small startups
• Managed product life cycle projects that included regulatory strategy for national and international pre-market approvals, product design, validation and post market surveillance
• Supervised cross-functional teams through the manufacturing of type I, IIa and IIb medical devices and regulatory remediation programs
• Collaborated in the implementation of a new software development life cycle policy (SDLC)
• Developed a software change management system along with the program (train the trainer)
• Managed software requirements matrix (traceability matrix) and conducted software validation test protocols
• Acted as change control manager providing guidance and review of all software (system/ equipment) changes
• Managed the implementation and of ISO 13485 and CE marking for multiple companies of varying sizes for class I, IIa and IIb medical devices
• Responsible for creating and implementing production documents including Standards, SOP, WI and manufacturing test methods
• Led the development,, and implementation efforts of a change management document process thus developing a CAPA feeder system
• Managed calibration non-conformance reports and engineering change control processes
• Performed statistical root cause analysis to solve product related problems, develop trends and understand process capability
• Managed supplier portfolios including audit schedule, corrective actions and supply strategy,
• Lead auditor for supplier audits related to supplier selection, performance evaluation and compliance surveillance for material suppliers, service providers and CMO’s
• Managed material supply strategy to ensure non-interrupted material availability
• Designed supply quality plans and directed weekly MRB meetings
• Managed the production batch record review, approval, material release and records archiving process
• Managed lean manufacturing exercises and risk analysis through key predictive indicator tools
• Responsible for managing the site relocation validation plan for two medical device companies and lead & executed multiple process and product validations protocols including IQ, OQ and PQ
• Authored and managed the DFMEA, PFMEA & FMECA and conducted DoE exercises, Gage R+R and risk analysis of new products and tech transfers

PROFESSIONAL EXPERIENCE:

Confidential, Burlington, MA

Director of Global Quality, Operations

Responsibilities:

• Confidential is the leader in corneal remodeling. Confidential has a combination medical device (UV laser device) and pharmaceutical (pre-filled aseptic syringes) product. As Director of Global Quality Operations
• I was responsible for material release in more than 20 countries and overall health of the Quality Management System. I joined Confidential to manage the manufacturing site relocation validation activities including redesigning the validation protocol and completing the report in only two days after the last verification exercise took place. I also implemented the first material release metrics and quality metrics dashboard only two months after my arrival to Confidential

Confidential, Lexington, MA

Acting Director, Quality Systems

Responsibilities:

Confidential is a private company developing a pipeline of minimally invasive urologic therapies. The TARIS platform is an implantable medical device designed to act as a drug delivery system (osmotic pump) and able to sustainably function in the body from 3 days to 3 months. During my tenure at TARIS, I managed the QMS re-design program in preparation for ISO 13485 readiness. I authored and lead the implementation of new SOP’s to achieve ISO compliance successfully completing the pre-audit and stage 1 audit of the process. I also managed the virtual supply chain and released investigational material (after QP approval in the EU only)

Confidential, Allston & Cambridge, MA

Sr. Program Manager

Responsibilities:

• Confidential develops and markets orphan drugs and pharmaceuticals to meet orphan market and Confidential t needs. Managed product/processes under aseptic fill finish methods. I joined the corporate Quality organization of Confidential, Cambridge site to lead remediation efforts as a result of FDA regulatory sanctions at the Allston Facility. I led remediation efforts associate with supplier qualification and life cycle management, materials management, quality agreements and batch records review process

Confidential, Natick & Quincy, MA

Quality Manager, System Validation.

Responsibilities:

• Confidential is a manufacturer of medical devices and pharmaceutical combination products for different markets including cardiology and urology. Products managed fell under short term and long term implantables with aseptic or end of line sterilization processes. I joined Confidential to support Project Horizon (FDA 483’s remediation).
• My dedication and commitment resulted in three promotions throughout six years of employment. During my tenure, I managed the validation program, supplier portfolios and supported the ERP validation program. As validation manager, I was responsible for change verification and implementation of new processes. As supplier portfolio manager, I performed over 100 national and international audits as lead auditor

Confidential, Raynham, MA & Skillman, NJ

Sr. Quality Engineer (QE)

Responsibilities:

• DePuy is the orthopedic division of Confidential & Confidential Inc. It produces off the shelf and custom made hips, knees, and a variety of orthopedic screws (all metal investment casting categorized as long term implantables). During my year at the Skillman site I supported Foundry production including but not limited to SCARS, NCRs, CAPAs and process validation (IQ, OQ, PQ). I was originally hired to work at the Confidential
• The complex known as the facility of Confidential & Confidential family of Companies housed the consumer goods division, and the then Confidential and Confidential medical device division. During my three years’ term at the I supported the oral health medical device division, special remediation projects as the polymers SME and leading the scale up to manufacture from pilot plant production

Confidential, Clinton, MA

Corporate Quality Project Manager (Contract).

Responsibilities:

• Confidential Inc. at the time of my employment was a contract manufacturer of custom injection molding products for the consumer goods and medical device industry. I worked at Confidential both during my undergraduate days at U-MASS-Lowell and then as part of my cap-stone project for my Masters in Engineering Management
• Program at Tufts University’s Gordon Institute. As an intern, I lead the request for quotation of custom injection molding projects and as a graduate student I relocated a type I and II medical device company from Chester UK to the Dominican Republic. I was responsible for equipment relocation validation, ISO 13485 transfer, and regulatory submissions and approvals required for CE marking registration