Fares Lahoud
North Smithfield
Summary
Dynamic quality compliance leader with extensive experience at Vertex Pharmaceuticals, excelling in inspection readiness and risk mitigation. Proven track record in regulatory compliance and continuous improvement, driving significant reductions in customer complaints. Adept at managing cross-functional teams and supplier audits, ensuring adherence to quality management systems.
Overview
26
26
years of professional experience
Work History
Associate Director, Quality Compliance
Vertex Pharmaceuticals
Boston
08.2022 - Current
- Manage inspection readiness initiatives for CDMOs, country affiliate offices and internal sites for regulatory inspections.
- Conduct strategy sessions, hot topics and storyboard planning across internal and external sites for inspection readiness.
- Identify high risk areas for inspections with SMEs and mitigate as needed.
- Monitor QMS overdue records and help drive overdue backlog metrics to lower levels across the organization and CMO partners.
- Lead and manage projects/teams within corporate objectives and project timelines.
- Collaborate cross functionally with internal and external business partners to resolve quality issues.
- Interpret cGMP regulatory guidelines and incorporate into existing control strategies.
- Cell & Gene Therapy, Boston, MA
Sr. Manager, External Manufacturing, CMOs
Rubius Pharmaceuticals
Smithfield
12.2021 - 05.2022
- Perform batch disposition for critical raw material suppliers, including apheresis (CD34 cells).
- Establish audit schedule and inspect suppliers for cGMP compliance.
- Track and tend audit reports and observations, CAPAs / SCARs.
- Manage Tech transfer activities for onboarding new suppliers and transferring existing products to additional sites.
- Smithfield, RI (impacted by business shutdown)
Supplier Quality Engineer / Supplier Quality Lead
Cytiva
Marlborough
01.2018 - 12.2021
- Work cross functionally to tech transfer of Single Use Products and medical equipment across factories around the globe.
- Approve supplier selection through product qualification, audits and development processes for medical device and In Vitro Diagnostic products, including hardware and electrical components.
- Evaluate supplier technical and engineering capability for new products through inspection of production process.
- Host visits with customers to investigate product complaints and product failures.
- Monitor Supplier Corrective and Preventive Action (SCAR) plans for execution, implementation and effectiveness checks.
- Developed and improved supplier change control process within Cytiva covering all consumable and hardware suppliers.
- This resulted in significant reduction of risk due to supplier changes and reduced customer complaints from 2 per quarter to 0 per quarter.
- Formerly GE Healthcare, Marlborough, MA
Sr. Specialist, Quality Compliance
Alexion
Smithfield
09.2016 - 12.2017
- Perform weekly walkthroughs (Gemba / Kaizen) of Production API manufacturing suites, QC and Warehouse to ensure site and personnel are inspection ready.
- Drive continuous improvement from the floor.
- Manage Inspection readiness initiatives, develop inspection readiness plan.
- Track Health Authority regulatory commitments and work cross functionally with groups to ensure timely closure.
- Smithfield, RI (impacted by plant shutdown)
Corporate Quality Auditor / Sr. Quality Engineer
Genzyme / Sanofi Genzyme / Sanofi Pasteur
Framingham
05.2008 - 09.2016
- Perform audits of Genzyme API Manufacturing sites and vendors to ensure compliance with US/EU cGMPs and Genzyme Corporate Quality requirements.
- Write and submit audit reports and approve CAPA plans/responses for the audits.
- Chairperson for the Change Control Board to present changes to the site.
- Developed Change Control Plan with change owners.
- Provided training on Track-wise and investigation authoring, root cause analysis, review and approval.
- Partnered with CMOs to help determine root cause for critical investigations (including BPDRs) impacting ACAM2000 Vaccine product, raw materials and diluent.
- Enabled Supply chain continuation through identification of root cause(s) for critical investigations of final product.
- Framingham and Canton, MA
Sr. Specialist, Quality Compliance
Amgen
West Greenwich
06.2006 - 12.2007
- Managed cGMP audit program to ensure company maintained and operated within cGMP compliance at all levels of the organization including product complaints, manufacturing, laboratory, investigational (NCs, OOS) methods, product specifications, and validation.
- Acted as host for Regulatory and other third-party inspectors throughout facility.
- Served as host and runner for inspectors by answering questions and providing documentation upon request.
- West Greenwich, RI (impacted by Plant Shutdown)
Section Leader, QA / Compliance
Barr / Par Pharmaceuticals
Spring Valley
04.2004 - 06.2006
- Managed Barr and PAR’s GCP internal and vendor audit program to ensure compliance activities with 21 CFR parts 320, 210, 211, 11, ICH guidelines, including E6 for clinical, Q7 for API, and GAMP guidelines for computer systems.
- As a result of this new program, PAR introduced a reduced testing program due to a greater assurance of quality of supplies received.
- Spring Valley / Pomona, NY
Associate Scientist / Auditor, Compliance and Clinical Release
Merck
Kenilworth
12.1999 - 04.2004
- Traveled overseas to direct and supervise the manufacture and packaging of stability and clinical batches for tech transfer manufacturing.
- Developed formulations, including analytical methods of proprietary Merck Animal Health compounds.
- Recipient of Merck Excellence award for OrbaxÔmarketed product.
- Formerly Schering-Plough, Kenilworth, NJ
Education
B.S. - Biology
NORTHEASTERN UNIVERSITY
Boston, MA01.1997
Skills
- Regulatory compliance
- Quality management systems
- Inspection readiness
- Supplier audits
- Risk mitigation
- Continuous improvement
Affiliations
- PDA – New England Chapter, 2016-2024
- Chair, Northeast Regional Discussion Group, American Association of Pharmaceutical Scientists, 2001-02
Training
- Kaizen / Lean Training, 2021
- Investigation Education Program for Sanofi Pasteur, 2016
- Institute of Validation Technology Seminar, 2017
- PDA – Course: Pharmaceutical and Biopharmaceutical Microbiology, 2012
- ASQ Certification, Quality Auditor, 2019
- PTI Certification- Conducting Internal Audits – Practical Essentials to Ensure GxP Compliance, 2004
- Temple University Graduate Courses: Good Manufacturing Practice, Drug Development, 2002
Timeline
Associate Director, Quality Compliance
Vertex Pharmaceuticals
08.2022 - Current
Sr. Manager, External Manufacturing, CMOs
Rubius Pharmaceuticals
12.2021 - 05.2022
Supplier Quality Engineer / Supplier Quality Lead
Cytiva
01.2018 - 12.2021
Sr. Specialist, Quality Compliance
Alexion
09.2016 - 12.2017
Corporate Quality Auditor / Sr. Quality Engineer
Genzyme / Sanofi Genzyme / Sanofi Pasteur
05.2008 - 09.2016
Sr. Specialist, Quality Compliance
Amgen
06.2006 - 12.2007
Section Leader, QA / Compliance
Barr / Par Pharmaceuticals
04.2004 - 06.2006
Associate Scientist / Auditor, Compliance and Clinical Release
Merck
12.1999 - 04.2004
B.S. - Biology
NORTHEASTERN UNIVERSITY