Regulatory Compliance Manager

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

 

Are you experienced in Regulatory Compliance?  Jabil is seeking a qualified Regulatory Compliance Manager to work in Brandywine, PA.  As the Regulatory Compliance Manager, you will manage all Regulatory Compliance Activities at the assigned sites. You will also drive internal audits and lead the preparation/readiness activities for customer audits, ISO Registration audits, Health Authorities Inspections and when required prepare responses to identified observations from this audit. The qualified person will have the objective of maintaining high quality standards for the product manufacturing process and compliance with all applicable regulatory requirements. This person will also be responsible for the absence of significant quality systems issues and regulatory compliance actions by government agencies.

In this Role you will:

• Be the Champion and subject matter expert for Regulatory Compliance programs.

• External inspection readiness and associated activities. Lead and manage site audit readiness activities to ensure inspection readiness at all times.

• Prepare and provide support to external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.

• 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 sites to determine impact on 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.

• Internal Audit Program Management and Execution.

• Establish and execute an effective internal audit schedule for site(s).

• 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 the 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.

• Continue to develop and enhance current regulatory knowledge at both the local and national levels to support surveillance activities.

• Responsible for proposing and execution of Quality System improvement opportunities.

• Support the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.

• Perform all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements

• Other duties as assigned

Job Qualifications

Knowledge, Education & Experience Requirements

• Bachelor’s degree required (Technical area, Business or Life Sciences) preferred.

• At least five (5) years of experience in the QSR/ISO-regulated medical device operation, including 2-3 years specific experience in a management/supervisory role.

• Experience in External Audit readiness and management.

• Supervisory experience, preferably QA exempt personnel

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