Senior Manager, Compliance & Continuous Improvement
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • Pennsylvania • United States
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Salary
💰 $122,000 - $212,750 per year
Job Level
About the role
- Provide leadership through partnerships/collaboration with site leadership, SMEs, Process Owners, Innovative Medicines (IM) Regulatory Compliance and key stakeholders, to oversee execution of program management activities for compliance improvements, and if necessary, remediation programs.
- Use SM platform site data (e.g., audits, inspections, QMS trends, etc.) to identify needs and facilitate the implementation of compliant solutions where appropriate.
- Partner with IM Q&C risk and proactive compliance to execute data driven improvement and provide insights.
- Establish, monitor and report on key performance measures to ensure actions are progressing as defined.
- Prepare routine and ad hoc program updates for platform leadership and stakeholders.
- Perform assessments of remediation deliverables as needed and required.
- Collect and review relevant metrics within and outside of the platform.
- Maintain abreast of regulatory changes through Established IM Q&C processes.
- Partner with IM PRC to ensure inspection readiness across the platform and oversight to NPI readiness.
- Develop and implement platform governance and oversight to compliance improvement activities.
- Work in partnership with IM PRC and IM Q&C Proactive risk management and compliance to maintain visibility and transparency of site compliance, inspection readiness, and NPI readiness.
Requirements
- Required Minimum Education : Bachelor’s degree (BS/BA).
- A focused degree in science, engineering, or organizational management is preferred.
- Required Years of Related Experience: Minimum of 12 years of experience in a QA & Regulatory Compliance role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment.
- Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them.
- Experience in the identification and management of GxP compliance risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner.
- Strong background in site-based quality with inspection experience.
- ISO 31000 Quality Risk Management, ISO 9001 Quality Management Systems, CQA, data analytics and reporting.
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
program managementdata analyticsrisk managementcompliance improvementGxP complianceremediation strategiesquality management systemsinspection readinessmetrics assessmentglobal cGMP requirements
Soft Skills
leadershipcollaborationcommunicationstakeholder managementorganizational managementinsight generationmonitoringreportingpartnershiptransparency
Certifications
CQA