The role
03Director, External Manufacturing Regulatory Compliance Oversight
Location: EU Johnson & Johnson Sites
Reports To: Senior Director, External Manufacturing Regulatory Compliance Oversight
Travel- Up to 25-40% (Global)
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
01Monitor and assess significant compliance risks across assigned external manufacturing partners.
02Identify emerging risk signals, recurring observations, inspection readiness concerns, and remediation trends.
03Conduct independent risk assessments and provide objective compliance challenge to accountable functions.
04Support escalation and governance processes for significant compliance risks.
05Evaluate recurring observations and compliance trends to identify systemic vulnerabilities requiring broader action.
06Provide compliance insights and recommendations to leadership and governance forums.
07Provide independent oversight and challenge of inspection readiness activities across assigned external manufacturing partners.
08Support readiness reviews, mock inspections, and risk-based assessments.
09Participate in regulatory inspection support activities before, during, and after inspections.
10Review regulatory commitments, remediation plans, and inspection responses for adequacy and sustainability.
11Monitor implementation of actions associated with significant inspection observations.
12Provide independent compliance oversight of contract manufacturers, contract laboratories, external sterilization providers, critical suppliers, and strategic partners.
13Assess whether oversight approaches appropriately reflect partner risk, product complexity, regulatory history, and business criticality.
14Review compliance trends related to inspections, deviations, complaints, investigations, CAPAs, and supplier performance.
15Challenge the adequacy of risk mitigation plans and remediation strategies.
16Support compliance evaluations associated with new partnerships, technology transfers, product launches, and network changes.
17Provide independent oversight of corrective and preventive actions arising from inspections, audits, supplier assessments, and significant quality events.
18Evaluate effectiveness verification activities and sustainability of remediation efforts.
19Assess root cause analyses for completeness and identification of systemic contributors.
20Identify repeat observations and recurring compliance issues requiring broader intervention.
21Support development of preventive actions designed to mitigate recurrence across multiple partners and products.
22Support governance forums through preparation of risk assessments, trend analyses, and compliance recommendations.
23Monitor external regulatory trends, warning letters, inspection observations, and emerging expectations impacting outsourced manufacturing.
24Translate regulatory intelligence into actionable insights and compliance recommendations.
25Support deployment of lessons learned across the External Manufacturing network.
