Principal Compliance Specialist at Johnson &… · Nijmegen

Principal Compliance Specialist Location: Nijmegen, Netherlands 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: Nijmegen, Netherlands Job Description: SECTION 1: 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. SECTION 2: DUTIES & RESPONSIBILITIES In accordance with all applicable country, federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: • 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. SECTION 3: 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. SECTION 4: 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 constructive conflict. • High tolerance for ambiguity in a complex environment. • Ability to make the complex clear and easily understood by others. • Ability to build partnerships both internally and externally. • Capacity to put the customer central to all thinking. • Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures. • Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity SECTION 5: ADDITIONAL POSITION REQUIREMENTS Cognitive/Behavioral Abilities • Ability to work in stressful/fast paced environment. • Ability to work and interact with co-workers to accomplish company goals in a team environment. • Management Skills. • Analytical/Problem Solving Skills. • Ability to communicate verbally and in writing. • Ability to learn. • Availability to work after regular schedule and during weekends. • Availability to work for limited periods of time in controlled manufacturing environments (CME’s) which require compliance with applicable requirements (gowning, etc.) SECTION 6: RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS • Reports to the Regulatory Compliance Director. • Encounters internal interface/interactions required for the duties and responsibilities defined in the previous sections of this Job Description. SECTION 7: LOCATION & TRAVEL REQUIREMENTS ☐ This Section is Not Applicable • This position is based in Nijmegen, NL. • Expected travel for both domestic and international: 10%. SECTION 8: EXTERNAL INTERACTIONS • Encounters external interface/interactions required for the duties and responsibilities defined in the previous sections of this Job Description. Required Skills: Preferred Skills: Audit and Compliance Trends, Coaching, Compliance Management, Compliance Policies, Compliance Risk, Confidentiality, Consulting, Controls Compliance, Developing Others, Internal Auditing, Investigation Techniques, Legal Function, Legal Services, Policy Development, Process Improvements, Tactical Planning, Technical Credibility The anticipated base pay range for this position is: €68 600,00 - €119 600,00 Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.