Sr. Mgr. Compliance & Contin Improvement

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 MedTech, 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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

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

Job Description:

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 MedTech, 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 https://www.jnj.com

The Sr. Manager Proactive Compliance and Continuous improvement has responsibility for supporting the development and management of Small Molecule (SM) Platform sites compliance improvement activities and remediation (as appropriate). The position will work in partnership with the Small Molecule site leadership, Small Molecule regulatory compliance and other Subject Matter Experts both within a site and outside a site to develop compliance improvement solutions and, if necessary, documented compliance remediation plans that include measurable time-based actions/deliverables.

The position will administer Project Management processes across the SM platform sites. The position will partner effectively to facilitate deployment of assigned compliance improvement initiatives/programs. This includes tracking plan performance, facilitating actions to address risks, and preparing consolidated / actionable view of risks across the platform and processes.

Key Responsibilities (Other duties may be assigned):

• 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

Major Duties & Responsibilities:

• 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 Duties

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

Required Minimum Education:

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

Required Years of Related Experience: