William Reiss Email and Phone Number
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GMP professional specializing in creative solutions to complex issues, process harmonization and improvement, CMO, product and team management. Experience in leading six-sigma based process improvement and harmonization teams, as well as developing and motivating others. Creative and active leader with expertise in both commercial and clinical vendor management, investigations, audit management, quality agreements, and data integrity. With a passion for harmonization and efficiency, and experience as a conference presenter, I thrive on using my presentation skills and ability to influence others to get the job done.Hobbies and Interests include: Skiing, hiking, coin collecting
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Senior Director Cmc QualityAcrotech Biopharma, Inc Apr 2023 - PresentEast Windsor, Nj, UsHead of QA/QCQuality Management Leader - commercial & clinicalLead QMS development & process improvementDevelop & maintain CMO and business relationshipsExecutive Leadership Team
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Director Cmc QualityAcrotech Biopharma, Inc Feb 2021 - May 2023East Windsor, Nj, UsHead of Quality Assurance and Quality Control• Responsible for Quality Management Systems, commercial and clinical• Lead QMS development and process improvement• Develop and maintain CMO relationships• Member of Executive Leadership Team
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Independent ConsultantSelf 2002 - PresentProfessional Quality Assurance Consultant providing training in cGMPs and hot topics to laboratory personnel through executive management. Provide general consulting and inspection readiness.
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Quality Relationship ManagerAlvogen May 2019 - Jul 2020Pine Brook, New Jersey, UsPoint of contact for a CMO packaging an injectable pen from pre-launch through commercialization. Responsible for release, investigations, late stage development and changes. Project lead for method transfer. Process improvement; metrics. Redeveloped the change management process and quality lead for process improvement reducing packaging rejects by 99.9%. -
Associate Director, Corporate QualitySun Pharma May 2017 - May 2019Mumbai, Maharastra, InDevelop and implement global strategies for contractor management, quality risk management, metrics, and quality agreements. Development and process improvement of quality systems. Support challenging investigations related to Contract Manufacturing Organizations, including CAPA by seeking effective solutions to the most challenging issues. Support product release and CMO audits. -
Sr Manager Qa Operations Commercial AmericasCelgene 2013 - 2016Summit, New Jersey, UsFull product lifecycle quality oversight (API to FP) including writing the APR, product release, vendor audits, deviation/complaint investigations approval, MBRs, validations, specifications and changes. Strategic development for vendor and data integrity programs. Co-host audits/inspections.• Developed strategy for product/vendor termination• Negotiated complex exit strategy in a challenging timeline satisfying all parties and realizing a savings of over $300,000 annually• Implemented and trained division on new approach to deviation investigations reducing investigation rewrites• Celgene “Living Our Values” Award for Outstanding Performance• Selected as Celgene Expert for Commercial Quality Agreements -
Senior Manager Supplier Quality Agreements & Global Sample RetainCelgene 2010 - 2013Summit, New Jersey, UsLed the global quality agreement process and sample retain programs. Approved all internal commercial product deviation and OOS investigations.• Developed/harmonized the global quality agreement program reducing cycle time by 75%• Led design/development of a $1,000,000 sample retain area to improve efficiency• Improved sample retain program efficiency/compliance resulting in a “no-findings” audit• Developed corporate policies, global and local SOPs • Led product withdrawal program for investigational products
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Manager, Contractor Management SystemsMerck 2006 - 2010Rahway, New Jersey, UsManaged the global technical/quality agreement program for all 72 legacy Schering-Plough facilities. Leader of the Global Supplier Certification Program and lead auditor for supplier audits.• Developed and implemented new approaches for processes resulting in significant reductions in cycle time• Ledcorporate-wide meetings to solve complex vendor issues• Frequently requested by sites to lead quality audits• 17 awards for performance excellence (2000-2009) -
Manager Supplier Management ProgramsSchering-Plough Research Institute 2000 - 2006Kenilworth, New Jersey, UsManaged 15 internal auditors, and member of Senior Management Leadership Team (corporate).• Developed and standardized the Internal Audit Program• 99% on-time completion rate of 250+ annual audits (NDA CMC section & quality audits)• Multiple awards for Excellence -
Qa SpecialistBayer Pharmaceuticals 1993 - 1999Leverkusen, North Rhine-Westphalia, DeSole Investigator for Technical Product Complaint InvestigationsInternal and Supplier AuditsDevelop and Implement cGMP Training -
ChemistFirst Brands Corporation (Now Clorox) Aug 1989 - Jun 1993Assistant Lab Supervisor - Routine QC chemical/physical analysis including ICP. Research novel products - complex product complaint investigations for automotive after market products. Led the laboratory effort successfully qualifying for Ford Motor Company's Q101 program attaining the highest award ever received, to date, for a Ford vendor.
William Reiss Skills
William Reiss Education Details
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North Carolina State UniversityAnalytical Chemistry -
Suny OneontaChemistry
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Huntington High SchoolCollege/University Preparatory And Advanced High School/Secondary Diploma Program
Frequently Asked Questions about William Reiss
What company does William Reiss work for?
William Reiss works for Acrotech Biopharma, Inc
What is William Reiss's role at the current company?
William Reiss's current role is Senior Director CMC Quality at Acrotech Biopharma, LLC.
What is William Reiss's email address?
William Reiss's email address is wi****@****rma.com
What is William Reiss's direct phone number?
William Reiss's direct phone number is +190867*****
What schools did William Reiss attend?
William Reiss attended North Carolina State University, Suny Oneonta, Huntington High School.
What skills is William Reiss known for?
William Reiss has skills like Quality Assurance, Validation, Pharmaceutical Industry, Gmp, Fda, Quality Agreements, Quality Audits, Process Improvement, Change Control, 21 Cfr Part 11, Quality System, Capa.
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