Director, Global Product Monitoring & Post‑Market Surveillance
DBV Technologies
7 hours ago
On-site
Warren, NJ
Operations
Key Responsibilities:
- Develop and execute global product monitoring and post-market surveillance (PMS) strategy for combination products.
- Lead post-market professionals for complaint handling, complaint determination/evaluation, vigilance reporting, field action/recall execution, and Annual Product Quality Review (APQR) management.
- Ensure compliance with global regulations/procedures for complaint and reportable event handling, including issuance of initial, supplemental, and final regulatory reports.
- Lead APQRs and integrate complaint trends, field performance, CAPA effectiveness, and stability data.
- Ensure compliance with 21 CFR Part 4, 820, 211, 6xx, ISO 13485, and ISO 14971.
- Collaborate cross-functionally (Medical Affairs, Regulatory, Quality Engineering, Quality Risk Management, Operations) to improve customer experience across the product lifecycle.
- Conduct signal detection and trending analysis for emerging risks; escalate and engage global stakeholders for rapid response.
- ~20% travel to France.
Qualifications:
- Bachelor’s degree in a relevant field; advanced degree preferred; regulatory and/or QA certifications a plus.
- 10–12+ years increasing responsibility in biotechnology/pharmaceutical GxP Quality & Compliance.
- Combination product/medical device/drug/biologics experience preferred.
- 7–10 years management experience in global environments.
- Experience leading complaint handling and regulatory reporting; leading field actions/recalls.
- Deep expertise in global PMS and APQR; strong knowledge of ISO 14971 and root cause tools.
- 5+ years with 1+ eQMS platforms (Veeva/ENNOV desired).
Technical & Functional Skills:
- Practical knowledge of FDA/ICH/GxP requirements to maintain and expand a product monitoring/PMS program.
- Experience implementing QMS/Governance meeting 21 CFR 211/820, ICH Q8/9/10, and ISO 13485 (21 CFR part 6xx desired).
- Knowledge of design controls and human factors; strong communication, analytical, and conflict-resolution skills.
- Fluent English required; French a plus.
- Develop and execute global product monitoring and post-market surveillance (PMS) strategy for combination products.
- Lead post-market professionals for complaint handling, complaint determination/evaluation, vigilance reporting, field action/recall execution, and Annual Product Quality Review (APQR) management.
- Ensure compliance with global regulations/procedures for complaint and reportable event handling, including issuance of initial, supplemental, and final regulatory reports.
- Lead APQRs and integrate complaint trends, field performance, CAPA effectiveness, and stability data.
- Ensure compliance with 21 CFR Part 4, 820, 211, 6xx, ISO 13485, and ISO 14971.
- Collaborate cross-functionally (Medical Affairs, Regulatory, Quality Engineering, Quality Risk Management, Operations) to improve customer experience across the product lifecycle.
- Conduct signal detection and trending analysis for emerging risks; escalate and engage global stakeholders for rapid response.
- ~20% travel to France.
Qualifications:
- Bachelor’s degree in a relevant field; advanced degree preferred; regulatory and/or QA certifications a plus.
- 10–12+ years increasing responsibility in biotechnology/pharmaceutical GxP Quality & Compliance.
- Combination product/medical device/drug/biologics experience preferred.
- 7–10 years management experience in global environments.
- Experience leading complaint handling and regulatory reporting; leading field actions/recalls.
- Deep expertise in global PMS and APQR; strong knowledge of ISO 14971 and root cause tools.
- 5+ years with 1+ eQMS platforms (Veeva/ENNOV desired).
Technical & Functional Skills:
- Practical knowledge of FDA/ICH/GxP requirements to maintain and expand a product monitoring/PMS program.
- Experience implementing QMS/Governance meeting 21 CFR 211/820, ICH Q8/9/10, and ISO 13485 (21 CFR part 6xx desired).
- Knowledge of design controls and human factors; strong communication, analytical, and conflict-resolution skills.
- Fluent English required; French a plus.