Principal Compliance Specialist, Nijmegen

Job Function Legal&Compliance

Job Sub Function Enterprise Compliance

Job Category Professional

All Job Posting Locations Nijmegen, Netherlands

Job Summary Under the supervision of the Regulatory Compliance Director, the Principal Compliance Specialist is responsible for establishing and maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements.

Duties&Responsibilities Audit Readiness and Management

Lead and manage external audit/inspection readiness activities to ensure site readiness at all times including audit logistics, front room/back room arrangements, identifying/preparing SME’s, etc.

Partner with site leadership to host external audits/inspections of the site e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, or JJRC/ERC.

Assess the risk and applicability of external audit/inspection observations from other J&J facilities to determine impact to the site.

Schedule and manage mock external audits/inspections as part of the External Audit/Inspection Readiness activities.

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

Ensure external audit/inspection results are reported to management having responsibility for the matters audited. Provide daily communications regarding potential non-conformities or observations.

Take the lead and provide guidance to prepare responses to any regulatory agency notification or correspondence associated with the site.

Take the lead and provide guidance to ensure timely and adequate responses to external audit/inspection observations related to the site, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.

Ensure timely and accurate reporting and publishing of external audit metrics. Drive compliance and improvements in metrics targets.

Internal Audit Program Management

Establish and manage an effective internal audit program for the site.

Ensure the resources needed to execute the internal audit schedule are provided.

Ensure internal audits are executed according to the established internal audit procedures. Ensure independence between the internal auditors and the activities being audited.

Provide guidance on the interpretation of the regulatory requirements.

Provide management oversight and direction to the internal auditors for the execution of the audit process.

Ensure internal audit results are reported to management having responsibility for the matters audited.

Ensure timely and adequate responses to internal audit observations, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow‑up with owners, and perform effectiveness monitoring and closure.

Ensure timely and accurate reporting and publishing of internal audit metrics. Drive compliance and improvements in metrics targets.

Ensure documentation and records related to the internal audit program are maintained.

Ensure all quality system elements/processes applicable to the site are audited and appropriate actions are taken to meet the business and regulatory requirements.

Execute/coordinate program(s) for qualification and training of internal auditors. Assess qualification of internal auditors on a periodic basis. Note: Programs can include franchise, supply chain, sector, and/or enterprise elements.

Enterprise, Sector and JJRC Support

Participate in JJRC audits as requested.

Where appropriate, ensure compliance representation on required site, region, sector, and/or enterprise teams/projects.

Support the creation and effective deployment of J&J Quality System standards at the site.

Connect and collaborate with the compliance teams of other sites, regions, and business groups.

CURVE Reporting

Assure that required compliance-related events (e.g. inspections) are entered into CURVE per required timeframes.

Assure that CURVE information is current and updated in a timely manner.

Metrics Collection and Reporting

Assure that internal and external audit metrics are consistently and accurately captured, and that they are reported and published at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).

Drive compliance and improvements in metrics targets.

Create reports and communicate performance against metrics to key stakeholders.

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

Escalations

Escalate quality issues 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 and compliance issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.

External Regulations and Standards

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/revised regulations and standards for the site.

Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations, and industry meetings.

Site Management Review and Data Review Board (DRB)

Provide input into Site Management Reviews and Data Review Boards (e.g. internal audits) to allow meaningful reviews.

Other tasks

Proactively communicate organizational and regulatory compliance related changes that may impact the site. Ensure feedback and alignment with said changes.

Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, and Manufacturing).

Provide/coordinate regulatory compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational/training strategies.

Perform performance appraisals and establish goals/objectives and development plans for direct reports, if applicable.

Comply with all environmental, safety and occupational health policies and ensure all direct reports comply with those requirements.

Comply and ensure compliance of employees under area of responsibility with the Quality System regulations, standards, company policies and procedures.

Responsible for communicating business related issues or opportunities to next management level.

Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Performs Internal Audits, including Approval of Investigations and performs Final Approval for Observations for other J&J Franchises

Performs other duties assigned as needed.

Experience and Education

Bachelor of Science Degree is required, preferably in technical area.

Experience in External Audit readiness and management.

At least five (5) years of experience in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical), including 2-3 years of specific experience in QA functions and a management/supervisory role.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

Lead Auditor Certification, highly preferred.

Expertise on the FDA/ISO/Health Authority Quality System regulations and standards, with the ability to relate these to business/quality issues.

Ability to make decisions which will effectively support the business and company policies.

Required proven leadership, teamwork, initiative, and assertiveness skills.

Excellent written and oral communication skills as well as report writing, presentation and training skills.

Ability to quickly build credibility within the Compliance community, executive management, external regulators, and industry.

Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units.

Proven track record of demonstrating collaboration across the organization and at all levels.

Balanced technical understanding of products and processes combined with superior business and compliance acumen.

Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results.

Ability to recognize, build support for change and engage in …