Yyyyyy x. yyyyyy

Quality Assurance Management Professional

Regulatory / FDA / EMA Compliance ~ Root Cause Analysis ~ Executive Relations

QMS ~ CAPA ~ International Experience ~ Training & Mentoring ~ Team / Project Leadership

         Bilingual (English and Spanish) professional offering 15+ years experience in quality assurance within pharmaceutical (tablets and caplets), medical device (type I, II and III) and parenteral (injectable, vials, ampoules, IVs, biotechnology products) industries.

         Possess advanced talents in supporting companies under consent decrees and warning letters/Form 483s.

         Excel in investigations, trend analysis, identifying root cause, CAPA (corrective and preventative action), and regulatory compliance.

         Able to evaluate existing processes and procedures to identify areas of weakness, and implement controls that heighten product quality and minimize expenses.

         Played a pivotal role in four FDA audits, three DEA audits, and two corporate audits with satisfactory results.

         Delivered significant staff coaching, mentoring, and guidance throughout initiation, tracking, trending and management of all manufacturing and packaging investigations, CAPA, and continuous improvement.

         Adept at preparing highly technical documentation including protocols and reports.

         Software skills include Microsoft Office (Word, Excel, PowerPoint), Minitab, SAP, Symphony EtQ, LIMS, ENOVIA, and TrackWise.

Uniqure Inc., Lexington, MA, August 2016 to present

QA Operations Lead (Consultant)

         Review manufacturing batch records and associated analytical data to facilitate compliant product disposition.

         Create, review, and approve standard operating procedures (SOPs), metrics reports, and other documents.

         Oversee the full spectrum of quality assurance during GMP cleanroom production operations.

         Perform FMEA, authorize change controls related to batch operations, examine deviations, and approve CAPA.

         Join forces with Quality Director to establish and maintain effective QA and quality engineering functions.

         Develop, administer, and maintain QA procedures while providing quality system training to all employees.

         Extensively support new product development efforts and continuing engineering projects.

Patheon - Ferentino, Italy, November 2015 to August 2016

Consultant

         Developed, administered, and maintained QA procedures to eliminate deviations related to sterile solution manufacturing, sterile vials, bottles, and ampoules.

         Partnered with Project Manager in detecting, charting, reporting, and trending key process metrics.

         Directed quality programs, initiatives, and activities to ensure flawless product quality and reliability.

         Trained, educated, coached, and mentored staff in quality systems management.

Bristol Myers Squibb Manat , Manat , PR, August 2015 to November 2015

Consultant

         Supported processes and equipment used to manufacture parenteral and biological drug products.

         Successfully completed Six Sigma project to identify areas needing improvement which subsequently captured considerable cost savings.

         Proficiently resolved deviations and enhanced quality and effectiveness of manufacturing systems.

         Authored technical documents to support quality-driven production operations.

Continued

Professional Experience continued Yyyyyy x. yyyyyy Page 2 of 3

Zimmer M.B.V, Ponce, PR, January 2015 to July 2015

Consultant

         Brought on board to eliminate critical CAPA backlog at a medical device facility.

         Generated investigation reports on ENOVIA platform and held MRB meetings to determine course of action and possible root cause.

         Explored and identified compliance issues prior to FDA inspection, and prepared and implemented action plan to ensure attainment of specific objectives.

Customed, Fajardo (PharmaServ), PR, August 2014 to November 2014

Consultant

         Teamed with management in driving QA functions which consistently complied with local and international regulations and standards.

         Championed remediation initiative in response to FDA 483 observations and played an integral role in seamlessly executing action plan.

         Prepared 21 CFR Part 806 recall submission letter and notification letter for recall submission consignees.

         Trained personnel in quality system and producers, and provided extensive supervision to ensure compliance.

         Developed risk assessments, authored SOPs, improved FMEA, and participated in internal audits.

Baxter (Avarent LLC), Round Lake, IL, February 2014 to December 2014

Consultant

         Spearheaded complaint remediation plan across three facilities, and delivered significant training, mentoring, and coaching to Baxter personnel.

         Communicated deficiencies found to task owners for correction and inputted in a spreadsheet for tracking purposes at corporate office.

         Confirmed resolutions for deficiencies and provided influential quality system training to all personnel.

J&J, Dominican Republic, February 2013 to December 2013

Consultant / Mentor

         Proactively mentored personnel within technical group, and initiated improvements to manufacturing and packaging processes.

         Advised managers in selection and development of staff, resources, and budgets necessary to achieve department goals.

         Delivered technical support for released products, critically evaluated product field performance and reliability, managed all aspects of CAPA, and contributed to preparation of company s regulatory submissions.

McNeil, Las Piedras, PR, February 2011 to November 2012

Non-Conformance Investigator (Consultant)

         Leveraged significant QA expertise toward conducting investigation in FDA consent decree environment.

         Resourcefully standardized procedures and processes, and controlled CAPA in engineering, production, and packaging areas.

         Led specialized team in completing non-conformances and CAPAs to resume production which was halted for one month, and trained personnel in use of new equipment and technology.

Pfizer Inc., Caguas, PR, September 2010 to February 2011

Consultant / Technical Services Specialist

         Delivered high-impact solutions and corrective actions to all manufacturing stages including blending, compression, and encapsulation.

         Successfully defended FDA inspection regarding Celebrex complaints resulting in zero observations.

         Designed strategy to submit Product Complaints investigations for approval within five business days.

Lilly Del Caribe PR01, Carolina, PR, February 2010 to September 2010

Internal Contractor / Quality Management Representative

         Enforced quality assurance within packaging area by performing internal audits and self-inspections, and approving documentation spanning validation reports, SOPs, investigations, facilities, deviations, change controls, and material disposal.

Continued

Professional Experience continued Yyyyyy x. yyyyyy Page 3 of 3

Amgen Manufacturing Limited, Juncos, PR, August 2009 to December 2009

Consultant / Mentor, Technical Group

         Created and executed CAPA to result in zero open investigations in more than 30 days.

Janssen Cilag, Gurabo, PR, May 2009 to August 2009

Consultant

         Executed investigations in manufacturing area including mixing, compression, coating, printing, sorting, and packaging to achieve rigorous QA objectives.

Biovail Laboratories, Dorado, PR, March 2008 to February 2009

Packaging Supervisor (Consultant)

         Efficiently coordinated and supervised packaging operations involving 30 employees.

         Controlled CAPA and non-conformances, prepared associated reports, and led investigations throughout lifecycle including root cause identification, plan corrections, and preventive actions.

Wyeth Pharmaceuticals, Guayama, PR, January 2007 to December 2007

Operational Excellence Specialist (Consultant)

         Directed several Six Sigma projects to improve processes, systems, and equipment in a production facility under FDA consent decree status.

         Coached staff throughout manufacturing and packaging investigations, CAPA, and operational excellence projects to streamline production.

Cordis LLC (J. Alifonso & Associates), San German, PR, January 2005 to December 2006

Consultant / Non−Conformance Investigator

         Investigated parylene, coating, and crimp and pack process within FDA 483 environment and enforced corrective action.

Amgen Manufacturing Limited & Ortho (PharmaServ), Juncos, PR, April 2004 to October 2004

Pharmaceutical Consultant

         Devised SOPs and cGMPs, expertly navigated CAPA, responded to non-conformances, and scrutinized issues related to manufacturing and quality activities.

Lilly Del Caribe Inc. (Kelly Services), PR, March 2002 to April 2004

QC Technician and Assistant QC Representative

         Applied sharp analytical skills toward providing high-impact technical support to manufacturing, packaging, finishing, warehouse, chemical laboratory, and environmental departments.

         Revised incoming area waste management policies and procedures to slash expenses by $1.5M.

MBA, Technology Management

University of Phoenix, Hato Rey, PR

Bachelor of Science, Industrial Biotechnology

University of Puerto Rico, Mayag ez, PR

ASQ Certified Manager of Quality/OE

Six Sigma Black Belt

PathWise CAPA Systems

Technical Writing

Yyyyyy x. yyyyyy

(DATE)

(HIRING AGENT NAME)

(TITLE)

(COMPANY NAME)

(ADDRESS)

(CITY/STATE/ZIP CODE)

Dear__________________:

I am currently seeking a long-term career opportunity in a quality assurance management capacity and am submitting my resume for your review. In advance, thank you for your time and consideration.

In addition to a scientific background and substantial consulting expertise, I bring to you solid experience in evaluating quality assurance within manufacturing operations, outstanding expertise in continuous improvement, and an exemplary blend of talents in SOP development, root cause analysis, team leadership, training, and internal and external quality audits. To complement these qualifications, I offer extensive experience within pharmaceutical and medical device industries. I have also orchestrated numerous investigations mandated by the FDA for companies in warning letter or consent decree situations.

As a proactive contributor to your organization, you will find me to be a highly experienced professional committed to supporting you in achieving your objectives through superior dedication and self-initiative. I am confident that I could be a valuable asset to <INSERT NAME OF ORGANIZATION> and encourage you to contact me at the information listed above.

Sincerely,

Yyyyyy x. yyyyyy