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
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
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:
* 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.
Required Skills and Abilities:
* Strong influencing and negotiation skills.
* Excellent written and oral communication skills.
* Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company.
* Strong decision making and analysis skills.
* Demonstrated conflict and change management skills.
* Strategic Thinking – ability to view bigger picture and translate complex issues into solution based answers that drive real and sustainable change.
* Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner.
* Flexibility – ability to travel globally if needed.
* Confidentiality – ability to maintain confidentiality as appropriate.
* Adjustment – self-confidence and self-control in high pressure environments, effective stress management.
* Systems Thinker – understanding how process / actions interact and influence other areas within a whole.
Percentage Traveled:
Approximately 10-20%global travel, with -higher peaks depending on business need
Required Skills:
Preferred Skills:
Business Alignment, Collaborating, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility