Mgr Cold Chain Sampling – Sanofi – Bridgewater, NJ
This position reports to the Director, PDMA Hand Sampling in US Quality & Compliance located in Bridgewater, NJ and is responsible to ensure conformance with FDA requirements, cGMPs, Prescription Drug Marketing Act (PDMA), and Sanofi internal standards for the Cold Chain Hand Sampling (CCHS) quality procedures. In addition, this position is responsible for assisting in the overall regulatory compliance of sales force samples administration.
The CCHS program is designed to enable Sales Professionals (SPs) across the U.S. and Puerto Rico meet the patient needs by replenishing various cold chain samples such as Toujeo, Afrezza, Apidra, and Praluent (future) in a timely manner through hand delivery to the practitioners in place of overnight deliveries being shipped from the distribution center.
The primary objective of the activity is to ensure product quality and patient safety .
Assist in support and monitoring of the Cold Chain Hand Sampling program including:
- Assist with various rollout activities for Sales Professionals added to the cold chain program
- Assist Sr. GMP PDMA Hand Sampling Manager regarding daily operational activities
- Conduct daily monitoring of the temperature monitoring system and email accounts as assigned
- Research/author release memos allowing Sales Professionals to resume hand sampling
- Notify Sales Professionals of at risk events and suspend events as required
- Notify Sales Professionals of corrective action to rectify at risk events
- Maintain CCHS equipment inventory and manual equipment change authorization process
- Document events and corrective actions as required
2. Provide continuous support for additional product launches of other cold chain products to be hand sampled or due to the expansion in the number of CCHS participants
3. Perform system testing (temperature monitoring and samples) when new products and modules are added for CCHS and/or during system upgrades
4. Assist with management of contractors reporting to PDMA Hand Sampling for CCHS product launches and on-going operations
5. Assist with documentation preparation for GMP investigations and audits conducted by PDMA HS department, when necessary
6. Act as CCHS Quality representative at supplier or cross functional department meetings, when necessary
7. Perform other special projects for US Q&C as needed
Qualifications
Basic Qualifications:
Bachelor’s degree from an accredited four-year college or university or applicable certification (Certified Internal Auditor or Certified Fraud Examiner)
and
5 years of relevant pharmaceutical samples compliance experience.
Preferred Experience:
• Knowledge of FDA, GMP regulatory requirements, and Prescription Drug Marketing Act
• Solid samples accountability experience
• Ability to productively interact with Sales Professionals and Sales Management
• Exhibit superior organization skills, must be able to multi-task
• Display advanced communication skills, both verbal and written
• Demonstrate teamwork skills and ability to lead and manage projects
• Excellent problem solving skills
• High level of attention to detail
• Adds value to the organization by assuming responsibility and accountability for successfully completing assignments or tasks, proactively takes action to complete priorities
• Regularly takes advantage of opportunities for professional growth through learning, and uses newly acquired knowledge and skills on the job and through demonstrated application
Proficient in Microsoft Excel, Word, and PowerPoint
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