Position Summary
- In support of the Chief Quality Officer, define and shape Quality strategy for Supply Chain and In-Market Quality.
- Provide global leadership to ensure product release and distribution comply with market cGMP and GDP.
- Lead Quality professionals in markets; advance “Quality and Compliance Excellence,” including post-market cGMP/GDP management.
Key Responsibilities
- Implement Global QMS standards across affiliate markets.
- Manage customer complaints (trending and regulatory reporting).
- Harmonize practices across markets and the Supply Chain network.
- Oversee Quality Operations in local markets/supply chain, including supplier/customer oversight, shortage quality input, health authority reporting, and recalls/market actions.
- Lead market import/distribution controls, product surety, serialization, and recall management when needed.
- Own market release via local RP release activities.
- Define quality metrics, identify gaps, drive corrective actions, and promote “Right First Time Culture.”
- Ensure inspection readiness/compliance in each market.
- Set transportation qualification strategy (primary/secondary) with Global Supply Chain.
- Resolve complex cross-business/unit issues ethically and in line with regulatory/business needs.
- Define strategy/process/metrics for Global Complaint Management, Regulatory Reporting (US/EU MDR), Product Security Investigations, and Complaint Trending.
- Anticipate regulatory directives/change; drive quality councils and chair the Global Supply Chain Quality Council.
Qualifications & Experience
- Bachelor’s required; advanced degree in pharma-related sciences preferred.
- 15+ years managing Quality/Compliance organizations.
- Proficiency in cGMP/GDP regulations (FDA/EMA or equivalent) and pharma distribution.
- Strong understanding of company policies, regulatory requirements, and supply chain/in-market quality.
- Excellent communication/interpersonal skills; fluent English (bilingual preferred).
- Global leadership experience; strategic, matrix leadership/influencing/negotiation skills.
- Judgment, relationship-building, ability to lead complex programs across cultures.
- Frequent travel to Above Market and cluster markets.
Compensation & Benefits (high level)
- $333,760–$404,440 base (plus eligible incentive cash/stock).
- Health, wellbeing, and financial protection benefits; paid time off varies by location.
Application instruction
- If you’re close to the requirements, apply anyway.