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Sr Manager, Quality Assurance - Global Product Distribution & Affiliates

La Verne, CA 91750

Posted: 01/24/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 598537 Is job remote?: No Country: United States

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.

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About La Verne, CA

Ready for your next career move? Explore exciting job opportunities in and around La Verne, California! Nestled in the picturesque San Gabriel Valley, this charming city offers a perfect blend of small-town charm and big city conveniences. From the beautiful Bonelli Park and nearby Raging Waters for outdoor enthusiasts to the eclectic art galleries like the Latino Art Museum and Candlewood Arts Festival, there's something for everyone here. Don't miss out on the delectable Mexican cuisine at Dona Maria, and catch a show at the historic Laemmle Theater. With its vibrant culture, diverse recreational options, and close proximity to Los Angeles, La Verne is an ideal location to take the next step in your career. Explore our job listings now and discover the opportunities waiting for you in this dynamic region!

Although this hasn't been an issue at Planet Pharma, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.