Sr. Mgr. Compliance & Contin Improvement

Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Quality

Quality Assurance

Professional

Athens, Georgia, United States of America, Beerse, Antwerp, Belgium, Dublin, Ireland, Geel, Antwerp, Belgium, Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Huejotzingo, Puebla, Mexico, Latina, Italy, São José dos Campos, São Paulo, Brazil, Titusville, New Jersey, United States of America

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

• 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.
• Oversee execution of program management activities for compliance improvement activities and governance/oversight of site compliance performance including inspection readiness.

Other activities as required, for example: strategic projects, process enhancement initiatives, Health Authority inspection support

Bachelor’s degree (BS/BA). A focused degree in science, engineering, or organizational management is preferred.

• 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.

• Strong influencing and negotiation skills.
• Excellent written and oral communication skills.
• Strong…