Senior Manager Regulatory Compliance

About this role

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Legal & Compliance

Job Sub Function: Enterprise Compliance

Job Category: Professional

All Job Posting Locations: Danvers, Massachusetts, United States of America, Halethorpe, Maryland, United States of America

Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Senior Manager Regulatory Compliance role to be located at Danvers, MA or Baltimore, MD.

The position of Senior Regulatory Compliance Manager is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements.

The Senior Regulatory Compliance Manager will be a member of the Abiomed and J&J Regulatory Compliance teams, will work with Quality Operations leads of the designated Abiomed sites and with the Regulatory Compliance teams of other regions and business groups.

The Senior Regulatory Compliance Manager is expected to collaborate with other groups within the J&J Regulatory Compliance (JJRC) organization to support execution of independent audits and special assessments and deploy compliance initiatives.

Key Responsibilities: • Lead and manage site audit readiness activities to always ensure inspection readiness

• Prepare and host external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site. Responsible for effective regulatory agency inspections.

• Audit preparation activities (auditor logistics, front room/back-room arrangements, identifying/preparing SME’s, etc.).

• Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site

• Schedule and manage mock inspections as part of External Inspection Readiness activities.

• Provide timely information to support the inspection process, including those that may be taking place at other sites / locations.

• Provide daily inspection communications regarding potential non-conformities.

• Prepare responses to any external inspection or other regulatory notification associated with site.

• Ensure adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners and perform effectiveness monitoring and closure.

• Establish and execute an effective internal audit schedule for site

• Execute against established internal audit procedures

• Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure

• Drive compliance and improvement in internal audit metrics

• Ensure quality system is periodically evaluated and audited and appropriate preventive/corrective action is taken to meet the business and regulatory requirements

• Where appropriate, execute program(s) for training and evaluating qualifications of auditors.

• Participate in JJRC audits as requested.

• Where appropriate assure representation on all required business unit, sector, and/or enterprise teams  

• Support the creation and effective deployment of internal J&J Quality System and/or Compliance standards.

• Connect and collaborate with other compliance teams

• Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).

• Drive compliance to Quality and Compliance metric targets.

• Create reports and communicate performance against metrics to key stakeholders.

• Highlight/communicate adverse trends in metrics and take risk-based action to remediate.

• Assure that required compliance-related events (e.g., field actions, inspections) are entered in CURVE or equivalent systems per required timeframes.

• Assure that information in the above system is current and updated in a timely manner.

• Escalate items in accordance with established procedures.

• Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives.

• Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.

• Proactively assess and influence the external environment by participating on industry and regulatory body work teams. As appropriate collect and provide site input.

• Communicate outcomes and trends to key stakeholders.

• Support implementation of new external standards/regulations

• Maintain current knowledge of regulatory changes through industry publications, seminars

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