Sr Mgr QA Compliance - I* - The Fountain Group

Hello,
My name is Arnold, and I am a Senior Talent Acquisition Consultant with The Fountain Group.  We are a national staffing firm with an array of Fortune 500 clients constantly looking for candidates such as yourself to join the team. I believe you have a great background and would love to discuss what's most important to you then compared to see if it matches our job.  
Currently I have an opening for Sr Mgr QA Compliance located in La Verne, CA. Details for the position are as follows:

Pay Rate: $82.63/hr.
This is a Hybrid Role - 3 days Onsite / 2 days Remote

• 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.

 
Qualifications:

• Bachelors (8+ years of exp) or Masters Degree (6+ years of exp) / open to PhD with less years of experience if they have the right working experience.
• Must have experience Finished goods distribution experience within Pharma - open to medical device industry
• Experience in US market and international product distribution, to include supporting/hosting FDA and State Pharmacy Board inspections. (Quality risk management)
• 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.

Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
If you are interested in hearing more about this position or other opportunities I may have please respond to this posting with your updated resume or contact me at (813) 425-2220, please reply/email your resume directly to Arnold.Suwan@TheFountainGroup.com
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.