Larry Kass

Larry Kass Email and Phone Number

Vice President Quality and Regulatory Affairs at Clothing 2.0 @ Clothing 2.0
Larry Kass's Location
Cornelius, North Carolina, United States, United States
Larry Kass's Contact Details
About Larry Kass

I have 15+ years pharmaceutical manufacturing and packaging experience. My range of experience includes FDA and ISO compliance; supplier quality; auditing; and manufacturing quality assurance. Since joining Septodont I have successfully hosted one FDA (Drug) audit resulting in a status of VAI; and four ISO audits during Notified Body transition also resulting in ISO 13483-2016 certification. R&D activities have resulted in one ANDA submission.Prior to joining Septodont I led compliance and supplier quality for PAR Pharmaceuticals (formerly Qualitest) a top ten U.S. maker of generic drugs. In this role I was focused on compliance and supplier quality, supporting three manufacturing sites, contract manufacturing, research and development, procurement and distribution activities. Product types supported were solid oral, liquid oral and topical dosage forms. My past experience also includes transdermal, powder fill and sterile manufacturing processes.My management style is that of a collaborator both within my group and with my business partners. I am goal oriented with an eye toward departmental, shared and company expectations. I have a BS in Business from The University of South Florida, and as a member of ASQ I have acquired Certified Quality Auditor (CQA) and HACCP Auditor credentials.

Larry Kass's Current Company Details
Clothing 2.0

Clothing 2.0

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Vice President Quality and Regulatory Affairs at Clothing 2.0
Larry Kass Work Experience Details
  • Clothing 2.0
    Vice President Quality And Regulatory Affairs
    Clothing 2.0 May 2020 - Present
  • Aphena Pharma Solutions, Inc.
    Director Of Quality
    Aphena Pharma Solutions, Inc. Feb 2019 - Jan 2020
    Cookeville, Tn, Us
  • Septodont
    Director Of Quality Assurance
    Septodont Nov 2016 - Aug 2018
    Saint-Maur-Des-Fossés, Fr
  • Par Pharmaceutical
    Director Of Compliance And Supplier Quality
    Par Pharmaceutical Dec 2008 - Jan 2016
    Chestnut Ridge, Ny, Us
    Direct the QA activities of a four person department responsible for Corporate Compliance and Vendor Quality activities for the Huntsville and Charlotte sites.• Initiate and coordinate recalls and Field Alert Reports for the Qualitest sites.• Manage the supplier quality program for Qualitest suppliers of raw materials and components.• Responsible for internal auditing program for the three Qualitest manufacturing sites and DC.• Established and currently maintain QA oversight of Distribution Warehouse.
  • Par Pharmaceutical
    Director Of Quality Assurance
    Par Pharmaceutical Apr 2003 - Dec 2008
    Chestnut Ridge, Ny, Us
    Directed all QA activities of three manufacturing facilities with three managers and fifty hourly employees responsible for Shop Floor Inspection duties, Documentation, Batch Release and Label Warehousing.• Primary FDA contact through eight cGMP inspections at the different sites.• Routinely lead interdisciplinary teams of senior management in each of three facilities for the purpose of addressing critical Quality concerns.• Investigated and wrote or reviewed Manufacturing, Complaint, and Laboratory OOS Investigations and Processing Variances.
  • Par Pharmaceutical
    Manager Of Quality Assurance
    Par Pharmaceutical Oct 2002 - Apr 2003
    Chestnut Ridge, Ny, Us
    Managed all Huntsville Tablets Facility MQA, Equipment Qualification and Process Validation activities.
  • Schering-Plough
    Operations Manager
    Schering-Plough 2001 - 2002
    Rahway, New Jersey, Us
    Managed Manufacturing and Packaging activities with seven direct reports including, Production Supervisors, Support and Engineering staff in a three shift environment. • Overall responsibility for one hundred plus hourly and salaried employees and plant performance.
  • Mylan
    Operations Manager (Udl Laboratories)
    Mylan 2000 - 2001
    Canonsburg, Pennsylvania, Us
    Directed all compounding and packaging activities with two direct reports, three supervisors and 45 hourly workers responsible for manufacturing and packaging of all pharmaceuticals at a 35,000 square foot facility.
  • Leiner Health Products
    Quality Assurance Manager
    Leiner Health Products 1994 - 2000
    Us
    Managed staff of 25 responsible for Receiving and Packaging Inspection, Documentation and Change Control, Auditing, Batch Release, and Label Control.

Larry Kass Skills

21 Cfr Part 11 Capa Change Control Glp Fda Gmp Pharmaceutical Industry Sop Quality System Technology Transfer Validation Regulatory Affairs Cross Functional Team Leadership Quality Auditing Quality Assurance U.s. Food And Drug Administration Corrective And Preventive Action Standard Operating Procedure

Larry Kass Education Details

  • University Of South Florida
    University Of South Florida
    General

Frequently Asked Questions about Larry Kass

What company does Larry Kass work for?

Larry Kass works for Clothing 2.0

What is Larry Kass's role at the current company?

Larry Kass's current role is Vice President Quality and Regulatory Affairs at Clothing 2.0.

What is Larry Kass's email address?

Larry Kass's email address is lk****@****rma.com

What schools did Larry Kass attend?

Larry Kass attended University Of South Florida.

What skills is Larry Kass known for?

Larry Kass has skills like 21 Cfr Part 11, Capa, Change Control, Glp, Fda, Gmp, Pharmaceutical Industry, Sop, Quality System, Technology Transfer, Validation, Regulatory Affairs.

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