Seasoned Quality Interim Leaders

Access Clora’s QA/QC interim leadership to fill the gap and augment your team.

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Senior Director, Clinical Operations & Quality Assurance

  • Initials: D.S.
  • Location: Mid-Atlantic Region
  • Therapeutic Areas: Oncology, Rare diseases, Dermatology, GI, Metabolic disorders, CNS, Hematology, Infectious diseases
  • Product Modalities: Drug, Small Molecules
  • Years of Experience: In over 20 years of consulting, I have assisted a number of early development-stage pharmaceutical companies develop a QMS that fits their current stage of development. I have performed gap assessments to prepare them for the next phase of development and helped them to revise their QMS and Policies/Procedures to move development forward. The bulk of my pharmaceutical clients have been working in oncology and/or rare diseases.
  • Previous Companies: Previously held positions at PRA Health Sciences, Johnson & Johnson, and various small/mid-sized biotechs
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Vice President, Quality Assurance

  • Initials: R.F.
  • Location: Mid-Atlantic Region
  • Therapeutic Areas: Rare diseases, Allergy / Immunology, Cardiovascular Diseases, Pulmonology / Respiratory Diseases, Ophthalmology, Infectious diseases
  • Product Modalities: Biologics, DNA & RNA Therapeutics, Drug Delivery, Monoclonal Antibody, Recombinant Products, Small Molecules
  • Years of Experience: Quality Assurance executive with 25 years of big Pharma experience, more than 10 years with emerging pharma and biotech companies managing their CMOs, and as VP of quality at a CMO, providing me with the experience of managing that type of relationship from both sides of the table. Now independent and providing cost effective contract QA solutions to companies advancing compounds through the clinical development cycle.
  • Previous Companies: Previously held positions at Insmed, Schering-Plough, OPKO, and various small/mid-sized biotechs
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Director of Gene Therapy QC

  • Initials: P.T.
  • Location: Southeast Region
  • Therapeutic Areas: Rare diseases, Infectious diseases, Hematology
  • Product Modalities: Gene Therapy, Monoclonal Antibody, Small Molecules, Devices
  • Years of Experience: 25+ years in the industry with 20+ years of cGMP Biotechnology experience (12 years managing FTEs) in QA, QC, global commercial and clinical fields. Expertise also extends to project management SME / Leadership, business process improvement lead, gene therapy, monoclonal, small molecule, device, global quality technology transfer lead, international market launch, QMS SME / PAI readiness lead, risk assessment lead, and Quality Regulatory Lead responsibilities.
  • Previous Companies: Previously held positions at BioMarin, Roche, and various small/mid-sized biotechs
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Head of Quality Control

  • Initials: N.T.
  • Location: California
  • Therapeutic Areas: Oncology, Rare diseases, Vaccines, Infectious diseases, Immunology, Inflammation, Hematology, GI, Endocrinology, ENT
  • Product Modalities: Gene Therapy, Monoclonal Antibody & ADCs, DNA & RNA Therapeutics, Biologics, Small Molecules
  • Years of Experience: 20+ years of hands-on experience in (GCP, GLP & GMP), Quality, Manufacturing & Regulatory Compliance (Remediation/Certification of Manufacturing sites for SVP-TS/LVP/Aseptic), Vaccines (including Covid-19 DS/DP Manufacturing, Interim Controls & Inspection Readiness mentoring), Monoclonal manufacturing, Gene Therapy, International Audits, API Manufacturing, Technology Transfers, Compliance Training, and overseeing Contract Manufacturing Organization responsibilities internationally.
  • Previous Companies: Previously held positions at Alexion, Fresenius, Novartis, and various small/mid-sized biotechs
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Vice President and Head, Quality

  • Initials: K.S.
  • Location: California
  • Therapeutic Areas: Immunology, Metabolic diseases, CNS, Oncology, Pain, GI
  • Product Modalities: Small & Large Molecules
  • Years of Experience: Valued quality and GXP regulatory compliance leader with 30 years of real-world boots-on-the-ground experience and insights into the complex and global rigors of small and large life science organizations from early-stage discovery through critical development milestones to product approval, launch and beyond.
  • Previous Companies: Previously held positions at Ironwood, Nektar, AstraZeneca, and various small/mid-sized biotechs