Lewis Blair

Greater Los Angeles Area 617-***-**** ad0ftw@r.postjobfree.com

Quality Assurance Management CAPA SME Quality Systems Expert

Over 20 years of Quality Assurance experience includes Director of Quality Assurance, Project Manager, Batch Record Disposition Manager, and other leadership positions. Extensive background and documented success in Quality Systems development and implementation within the pharmaceutical and medical device industries. Recipient of multiple awards for innovation, project management, and team leadership.

OVERVIEW: Combine an advanced technical and engineering background with team and program leadership skills to achieve perennial success in QA objectives. Demonstrates a career-long commitment to Quality Systems, CAPA Programs, and Continuous Improvement excellence, including Quality Core Values of Accuracy, Consistency, Efficiency, and Traceability. Utilize a Position vs. Intent communication technique to gain buy-in for quality control, process improvement and compliance initiatives.

Solution Innovation successes includes extensive CAPA Remediation Program Management for DePuy Synthes, migration from paper to electronic, Part 11 compliant documentation control at Vertex Pharmaceutical. Proven record of creating and maintaining QMS compliant with: FDA 21CFR820 / 210 / 211 / 803 / 806 / 804 / 4 / 11, ISO 13485, ISO 14971, and ISO 9001. Proven record in meeting critical product to patient requirements.

Professional Experience

AMGEN – October 2022-Present (Consultant)

Quality Assurance Manager

Lifecycle review and approval of Combination Products, with particular attention to Method development and approval, ensuring regulatory, Quality Systems, and GMP compliance.

Santa Cruz Nutritionals – March 2022-July 2022 – Company Lay-off

Quality Systems Manager

Responsible for the integration of all systems feeding directly into manufacturing, Improved the timely release of Master Batch Records and Production Batch records from one-day to one-week prior to production.

Set up global Corrective Action, to align all department functions feeding into manufacturing.

AMGEN – November 2020-December 2021

Quality Assurance Consultant Special Projects Combination Products

Quality Assurance representative ensuring regulatory, Quality Systems, and GMP compliance, while providing advice, and quality oversight for transfer to design controls and development.

KITE, A Gilead Company – March 2019-October 2020 – Company Lay-off

Disposition Manager

Final decision on batch record disposition of T Cell lots for shipment to clinic for patient re-infusion.

Maintained a 100%, on-time review and disposition of batches, with a daily disposition of three to six batches.

Extensive deviation review directly contributing to my disposition decision, involving large cross-functional interaction.

Maintained Quality Metrics, with weekly presentations to the Quality Lead Team.

Received multiple awards for Teamwork and Performance Excellence.

CLIENT COMPANIES – Multiple Locations – 2013-2018

Quality Assurance Specialist Program Manager Quality Systems’ Lead

Consult with client companies to provide expertise and support on quality assurance, regulatory compliance, and related matters. Met and exceeded requirements in every contracted position, including the following:

Quality Management System Lead, Shire (Pharmaceutical & Medical Device), 3/2018-10/2018 – Served as Change Control Specialist for MasterControl migration to Veeva Vault (Veeva Vault Business Administrator). Used QMS remediation to reduce 60K document count via end-to-end process development.

Program Manager/Risk Management Remediation, DUSA (Pharmaceutical & Medical Device), 6/2017-12/2017 – Directed engineering development for dermatology product line. Lead DFMEA remediation in response to FDA 483s. Oversaw CMO management of design and assembly houses.

Change Control, Risk Management & CAPA Specialist, Spectranetics (Medical Device), 4/2017-6/2017 – Managed cross-functional coordination of CAPAs that required FMEA remediation. Drove CAPA program remediation of 196 CAPAs resulting from FDA inspection 483s.

Quality Management System Specialist, Lake Region Medical (Medical Device CDO/CMO), 10/2016-3/2017 – Conducted ISO 13485:2016 gap analysis, remediated Customer Complaint intake and reporting, and created a program for standardization of Quality Management Systems across 31 sites.

Quality Assurance Consultant, Acceleron Pharma (Pharmaceutical), 4/2016-9/2016 – Performed executed batch record review and lot release for clinical trial of cellular growth product. Remediated Quality Systems.

Change Control/CAPA Quality Assurance Consultant, Fresenius Medical Care (Medical Device), 7/2015-4/2016 – Harmonized CAPA and Quality Systems across 8 North American and Canadian sites. Oversaw FMEA management and created process to standardize for 21CFR806 objective reporting determination.

Quality Assurance Consultant, Shire, 2/2015-6/2015 – Completed review and remediation of Quality Systems processes; remediated deviation, CAPA, and change control backlog.

Quality Assurance Consultant, Acorda Therapeutics (Pharmaceutical), 10/2014-1/2015 – Planned and executed comprehensive batch record review.

Quality Assurance Design Control, CAPA, Change Control SME, J&J DePuy Synthes, 3/2013-8/2014 – Remediated 600+ audit CAPAs for Verification of Effectiveness and FMEA remediation objective.

BRAINTREE LABS, INC. – 1/2012-1/2013 – Company Lay-off

Director of Quality Assurance

Brought on board to create and lead a Quality department, including its Quality Systems compliant with FDA 21CFR820. Recruited, hired, and managed team of up to 8, including QA Investigations Manager and Training Manager. Set up Customer Complaint process and monitored all CAPA, Complaint, and QA System requirements.

Led team in producing multiple quantifiable improvements, including increasing production yield from ~75% to 90%, reducing manufacturing downtime incidents by ~50%, decreasing manufacturing downtime by ~30%, raising daily production by ~15%, and reducing number of Planned Deviations by 40%.

Created and implemented training program that included hiring Training Manager and developing ongoing cGMP training to meet 21CFR210/211 requirements.

ENZYMATICS – Beverly, MA – 1/2011-12/2011 – Company Lay-off

Director of Quality Assurance

Recruited and hired to build a Quality department, including Quality Systems compliant with FDA 21CFR820. Hired and led team of up to 5, including engineers and document control team members. Developed documentation and configuration management processes as well as production verification / validation requirements.

Created and executed Quarterly Management Review requirements, advocating for their importance and benefit on an organization-wide basis.

VERTEX PHARMACEUTICALS – Cambridge, MA – 2/2005-1/2011

Project Manager, Quality Systems Development (2008-2011)

Senior Quality Assurance Specialist (2007-2008)

Documentation Manager (2005-2007)

Progressed rapidly through increasing responsible positions with a billion-dollar company. As Project Manager, directed application transition and change management initiatives. As Senior QA Specialist, oversaw supplier auditing and managed supplier communications via encrypted server. As Documentation Manager, reviewed technical files for 510(k) submissions.

Created Lotus Notes documentation control and eventually led the scale-up from Lotus Notes to QUMAS for document workflow management. Developed the change control process in Trackwise. Improved the user experience through both initiatives by creating a defined, consistent process.

Earned 4 VOCAP Awards (Vertex Outstanding Contribution Award Program):

-VOCAP: Project Management of multi-site, quality system alignment.

-VOCAP: Migration to Part 11 complaint documentation control.

-VOCAPs (2): Development of the Documentation department.

Education & Credentials

Bachelor of Science in Mechanical Engineering (BSME) – University of Hartford – Hartford, CT

Awards included 1st Place in both the Freshman and Senior Design Competitions,

President of the Kappa Mu Engineering Honor Society

Certifications/Licenses – Certified ISO Lead Auditor, Royal Accreditation Board (RAB)

Technology Summary –

Advanced proficiency in the Microsoft Office Suite,

Veeva Vault (Business Administrator),

Lotus Notes (Senior Developer),

Oracle,

AGILE,

QUMAS,

Trackwise,

MasterControl, and

Teams and Miro

Community Involvement –

President & Artistic Director, Lexington Youth Summer Theatre (LYST), 21 years,

Big Brother, Big Brother Organization of Eastern Massachusetts, 10 years.

Contact this candidate