• Top Performer who xxxxxxkes sound decisions to reflect positively on global business operations in alignment with a pharxxxxxxceutical and / or medical device company s vision, value, and goals to attain a competitive advantage and generate robust growth, and works to build relations with the EXXXXXX, MHRA, TGA, GMED, PMDA, ANVISA, and the FDA.
• Visionary Professional who rises above challenges to achieve winning outcomes, along with demonstrating talent in adopting creative quality system process analysis and improvements to ensure global compliance and core quality.
• Excellent Communicator who develops synergistic relationships with C-level executives, senior-level decision-xxxxxxkers, cross-functional teams (e.g. R&D, Process Development, Engineering, Xxxxxxnufacturing, Technical Services), and clients; who excels in autonomous and collaborative work environments; and who leads staff by example and with integrity.

Head of Quality ARIMF (2016 Present)

• Capitalize on the opportunity to lead forward-thinking companywide quality-focused assurance and control initiatives at Alexion s Rhode Island Xxxxxxnufacturing Facility (ARIMF), including directing top-performing teams in meeting and / or exceeding goals across all facets of commercial and clinical xxxxxxnufacturing site operations based in Smithfield, RI.

  Ensured internal / external compliance met and / or exceeded Alexion and government standards.

Senior Director Quality Assurance Operations (2013 2016)

• Utilized broad scope of industry knowledge and dynamic business acumen toward xxxxxxnaging a quality assurance operations team at a fast-paced Smithfield, RI xxxxxxnufacturing facility, including directing all QA functions and staff located at the Alexion Rhode Island Xxxxxxnufacturing Facility for both clinical and commercial xxxxxxnufacturing efforts.

  Delivered quality assurance documentation control and records xxxxxxnagement.

  Spearheaded efficient compliance, quality systems, and QA validation and training.

  Xxxxxxnaged contract xxxxxxnufacturing organization activities for top clinical drug products.

Director Quality Assurance Operations (2012 2013)

• Strategically steered quality assurance operations teams at a high-volume Smithfield, RI-based xxxxxxnufacturing facility, including overseeing QA operations staff and functions at Alexion facility for a commercial and clinical xxxxxxnufacturing.
• Directed daily QA oversight of xxxxxxnufacturing and QA disposition of commercial and clinical drug substance batches.

  Evaluated deviation / failure events and assessed impact to products.

  Used established root cause analysis and applied risk-based decision-xxxxxxking.

Director Quality Assurance

• Drove business growth by coordinating and xxxxxxnaging quality assurance and documentation activities for West Lebanon, NH and Hopkinton, XXXXXX sites, including additionally coordinating quality system efforts at Limerick, Ireland site.

  Led quality assurance support for clinical programs, GLP lab, and contract xxxxxxnufacturing organizations.

  Supported clinical and commercial xxxxxxnufacturing, packaging, and distribution activates at NH and XXXXXX sites.

Senior Xxxxxxnager Quality Assurance (2010) ￨ Xxxxxxnager Quality Assurance (2006 2009)

• Xxxxxxximized bottom-line perforxxxxxxnce by cohesively developing and xxxxxxnaging a team of quality assurance professionals, deviations, and nonconforming product reports, and serving as signature authority for Director of Quality.
• Directed detailed analysis and presented weekly inforxxxxxxtion at exception meetings, as well as leading quarterly xxxxxxnagement review meetings concerning nonconforming product, CAPA, root cause, and failure modes analysis.
• Coordinated and conducted GMP / quality new hire training, annual refresher training, and quality system training sessions, as well as liaising among xxxxxxnufacturing and quality control teams to resolve issues from record reviews.
• Led QA support for capital expansion commissioning and qualification activities of new cGMP xxxxxxnufacturing facilities, wrote quality system procedures, and supported failure investigations and regulatory submissions.

  Provided technical and quality input to RA for CMC submissions.

  Expertly coordinated quality internal audits for Stryker s cGMP facilities.

  Coordinated all xxxxxxterial review board meetings for the West Lebanon site.

  Performed quality vendor audits for suppliers of Class I raw xxxxxxterials and components.

Yyyyyy x. yyyyyy ￨ Page Two ￨ (xxx-xxx-xxxx

Quality Assurance Associate II (2004 2005)

• Expertly supported company in upholding cGMP compliance by demonstrating comprehensive knowledge of ISO xxxxxx standard, European drug regulations (MCA Orange Guide; Eudralex), FDA medical device and drug regulations (21 CFR Part 210, 211 and 820), and ICH guidelines, along with performing careful review of documentation and records.
• Supported vendor assessment / vendor qualification program, and assisted in performing vendor audits to meet goals.
• Collaborated with xxxxxxnufacturing and quality control to resolve open issues resulting from record reviews and audits.
• Actively tracked, followed up, reported, and assessed deviations, change control, and corrective and preventative actions.

  Performed regular walkthrough audits of biotech xxxxxxnufacturing facilities.

  Led review of quality control assays and validation protocols and sumxxxxxxry reports.

  Successfully xxxxxxintained detailed record disposition and accurate lot traceability database.

  Coordinated and conducted GMP / quality new hire and annual refresher training for employees.

Senior Regulatory Compliance ￨ Quality Assurance Specialist (2004)

Regulatory Compliance ￨ Quality Assurance Specialist (2002 2004)

• Successfully served as acting head of a U.S.-based Pharxxxxxxceutical Quality Assurance Unit, including coordinating and xxxxxxnaging QA Consultant activities to assure needs were met for both livestock and companion anixxxxxxl projects.
• Directed all QA activities of the Clinical, Safety, and Xxxxxxnufacturing teams including GLP compliance for Intervet s research farm facility in DeSoto, KS, as well as implementing QA and compliance functions for registering products.
• Exhibited knowledge of FDA regulations and CVM guidance documents, as well as QA and compliance procedures.

  Reviewed regulatory submissions with applicable regulations and guidelines for quality and compliance.

  Conducted GLP / GCP compliance audits of contract research organizations used to support product studies.

  Led GLP / GCP audits of study protocols, raw data, and final reports, and conducted critical phase inspections.

Clinical Research Specialist (2001 2002)

• Played a vital role in assisting project leaders with high-volume U.S. registration of pharxxxxxxceutical anixxxxxxl health products, including conducting effective communications and monitoring, as well as regulation and protocol training.
• Handled clinical, laboratory, and European study data review and quality control, and regulatory submission of all QC.

  Planned, conducted, and monitored U.S.-based clinical study sites.

  Designed, developed, and implemented various protocols at study sites.

  Built working knowledge of FDA regulations and CVM guidance documents.

Xxxxxxster of Science in Biochemistry (3.7 GPA) University of Scranton

Leading @ Alexion

Hiring Your Team ￨ Coaching Your Team ￨ Inside Out Development

Lead Investigator Qualification Training ￨ People Xxxxxxnager Training

Leading & Xxxxxxnaging Your Team ￨ Introduction to Lean & Problem Solving

Additional Web Seminars

Destin Leblanc Fundamentals of Cleaning Validation ￨ Microrite, Inc. Biofilm Basics

RX360 Upstream Supply Chain Security￨ Global Compliance Panel GMP for Phase I Products

Tungsten Shield Group Web Seminars

Meeting Regulatory GMP Requirements During Clinical Xxxxxxnufacturing

Identification, Correction & Prevention of Huxxxxxxn Errors in GMP Xxxxxxnufacturing and Lab Processes

Sampling & Testing Within a Regulatory Framework FDA / EXXXXXX / Health Canada Expectations & ASQ Sampling Tables

Additional Professional Training / Development

GEA Mechanical Equipment Harvest Centrifugation

Kepner Tregoe Problem-Solving & Decision-Xxxxxxking Workshop

PDA Europe PIC / S Workshop: GMP Inspection Practices & Trends

Global Compliance Panel Zero Defects & the cGMPs Pros & Cons

TBM Lean Sigxxxxxx for Process Industries Training Lean Transforxxxxxxtion Leadership

BPOG24 Meeting Drug Substance Program Review ￨ BPOG Conference Innovative Quality Systems

Summit Leadership Group Building a Team Culture of Trust, Accountability, Motivation & Peak Perforxxxxxxnce

Date

Hiring Agent Name

Company Name

Address

City/State/Zip Code

Dear__________________:

I am exploring a new career opportunity within a challenging [ Insert Job Title ] role, and I believe that I can xxxxxxke a positive contribution to your bottom-line perforxxxxxxnce.

To acquaint you with my background, I can offer experience in Quality Assurance, Xxxxxxnufacturing Operations, Systems Analysis / Development, Short- / Long-Term Planning, Trends Tracking, and Multi-Process Optimization. I am also highly skilled in Team Building, Training / Development, Project Xxxxxxnagement, and Cross-Functional Peer Collaborations, as well as Budget Forecasting, Auditing, Global Regulatory Compliance, Inspections, and Communications.

Currently, as Head of Quality for Alexion s Rhode Island Xxxxxxnufacturing Facility (ARIMF) within Alexion Pharxxxxxxceuticals, I expertly lead forward-thinking companywide quality-focused assurance and control initiatives, including ensuring internal / external compliance met and / or exceeded both Alexion and government standards.

Prior to this, as a Senior Director of Quality Assurance Operations, I successfully xxxxxxnaged a top-performing team at a fast-paced Smithfield, RI xxxxxxnufacturing facility, including directing all QA functions and staff located at the Alexion Rhode Island Xxxxxxnufacturing Facility for both clinical and commercial xxxxxxnufacturing efforts.

A sampling of my achievements in this latter role included:

  Delivering quality assurance documentation control and records xxxxxxnagement.

  Spearheading efficient compliance, quality systems, and QA validation and training.

  Xxxxxxnaging contract xxxxxxnufacturing organization activities for top clinical drug products.

To complement this experience, please note that I earned a Xxxxxxster of Science in Biochemistry (3.7 GPA) and a Bachelor of Science in Biology (Cum Laude, 3.6 GPA, Philosophy Minor) from the University of Scranton.

[ Suggestion! Address Here Any Skills / Qualifications / Achievements Relevant to the Job Posting ]. As this is just an example of my abilities, please kindly refer to my enclosed resume for additional experience.

As a proven leader, you will find that I am positioned to deliver both immediate and long-term results with a continued commitment to exceeding your team s goals. I am eager to discuss how my qualifications uniquely xxxxxxtch your current and future needs, and look forward to interviewing with you soon.

Sincerely,

Yyyyyy x. yyyyyy