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Sr Manager, Quality Assurance - Global Product Distribution & Affiliates
California USA 91750 La Verne, CA 91750 US
Job Description
Target PR Range: 58-78/hr)
*Depending on experience
• 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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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