Website Varite, Inc
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Company : Varite, Inc
Sr Manager, Quality Assurance – Global Product Distribution & Affiliates.
La Verne – On site for 3 core collaboration days minimum
Preferred Education Level: 8+ years of experience in a GDP/GMP environment related field and a BS or BA, or 6+ years of relevant experience and a MS.
Experience in US market and international product distribution, to include supporting/hosting FDA and State Pharmacy Board inspections. Experience in applying QRM. Ideally will have provided QA oversight of contracted 3PL services.
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as it pertains to a US and Global product distribution operation.
" Maintains routine programs and processes to ensure high quality products and compliance with FDA current Good Distribution Practice (GDP) and National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements.
" Supports Global and Regional QA teams as well as working cross-functionally with Supply Chain, Warehouse, Customer Service personnel as well as facilities, EHS and validation colleagues in all aspects of product distribution.
" Interfaces with and provides QA oversight of contracted 3PL activities pertaining to product distribution and process performance issues.
" Participates in developing Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met.
" Reviews shipping records, environmental monitoring and associated data relating to product distribution activities.
" Hosts NAPB external audits and interacts closely with external regulators/stakeholders.
" Co-hosts/supports external FDA audits and internal audit programs.
" Participates in the development & delivery of training programs regarding relevant to US and Global product Distribution.
" Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to QA Operations.
" Conducts gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards.
" Participate in or where relevant lead local and corporate projects and process improvement initiatives, as required.
Knowledge, Experience & Behaviours:
" Experience in US market and international product distribution, to include supporting/hosting FDA and State Pharmacy Board inspections.
" Demonstrates proficiency in Good Distribution Practices (GDP), Verified-Accredited Wholesale Distributors (VAWD) and Drug Supply Chain Security Act (DSCSA) requirements.
" Demonstrates working knowledge with good proficiency in Microsoft Office applications.
" Experience in providing QA oversight of contracted 3PL activities.
" Resilient profile with the ability to deliver in a challenging environment.
" Ability to engage and manage multiple stakeholders to achieve the objective.
" Organised with systematic approach to prioritisation.
" Positive attitude
" Motivated to learn new skills and embrace new experiences.