Lead Compliance Specialist

<p style="text-align:left !important">At Johnson &amp; 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 <a target="_blank" href="https://www.jnj.com."><span style="color:#0000ff"><u>jnj.com</u></span></a>.</p><p></p><p>As guided by Our Credo, Johnson &amp; 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 &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p></p><p></p><p style="text-align:left"><b><span><span>Job Function: </span></span></b></p>R&amp;D Operations<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Clinical Trial Project Management<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Category:</b></p>Professional<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>All Job Posting Locations:</b></p>Lisbon, Portugal, Madrid, Spain<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Description:</b></p><p><b>Position Summary:</b><br />The Lead Compliance Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson &amp; Johnson global processes and procedures.</p><p><br /><b>Principal Responsibilities:</b><br /><b>Quality and Compliance Oversight Activities</b><br />1. Monitor compliance risk and ensure mitigation/remediation actions are defined.<br />2. Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct, and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities:<br />▪ Conduct Compliance Monitoring Visits.<br />▪ Perform assigned reviews of Trial Master File, training compliance documentation and other checks per CRM Integrated Quality Plan for the trial.<br />▪ Planning and execution of local QC checks<br />▪ Support and advise local and central study teams in root cause analysis of significant observations.<br />▪ Ensure appropriate filing of the QC reports.<br />3. Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals.<br />4. Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed.<br />5. Collaborate with local and central business partners in timely CAPA setting and implementation. Provide CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions.<br />6. Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents.</p><p><br /><b>Local Onboarding and Consultation</b><br />7. Support onboarding of new hires.<br />8. Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc.<br />9. Provide advice regarding SOP, system and GCP questions of moderate complexity.<br />10. Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.<br /><br /><b>Local regulatory intelligence</b><br />11. Perform impact assessments of new/revised local regulations, guidance, and standards.<br />12. Support central functions in ensuring local intelligence is up to date (e.g., CLRR)</p><p></p><p><b>Collaboration with Business Quality</b><br />13. Support LOC Management Review in collaboration with LOC Commercial Quality partners.<br />14. Support local suppliers’ assessments as appropriate.<br />15. Support annual Due Diligence update, certification, and training of local suppliers, if applicable.</p><p><br /><b>Principal Relationships:</b><br />The Lead Compliance Specialist reports into the Director Compliance (Region)/Senior Manager Compliance as applicable and may have a dotted line to the Assoc Director/ Sr Manager/ Director/ Sr Director Country Head. Is a member of the regional Compliance team.</p><p></p><p><b>Education and Experience Requirements:</b></p><p><b>Education</b><br />A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 5-6 years relevant experience equivalent is required. A minimum of 4 years of previous Pharmaceutical Industry experience is required, with at least 3 years of GxP experience within clinical research and development and/or quality assurance.</p><p><br /><b>Related Experience</b><br />▪ Knowledge of the overall drug development process.<br />▪ Developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities).<br />▪ Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions.<br />▪ Ability to translate data into information and strategies into executable action plans improving the business.<br />▪ Ability to motivate professional colleagues and stakeholders.<br />▪ Conflict resolution/management and negotiation skills.<br />▪ Ability to independently plan, organize, coordinate, manage and execute assigned tasks.<br />▪ Experience of the key customers’ business processes and practices.<br />▪ Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.<br />▪ Experience with regulatory submissions (NDA, BLA) is an asset.</p><p><br /><b>General Skills</b><br />▪ Problem solver<br />▪ Collaborator<br />▪ Highly committed to quality and compliance<br />▪ Flexible and persistent<br />▪ Good conflict handling/negotiation skills<br />▪ Able to create win-win situations with internal and external partners.<br />▪ Knowledge of the corporate structure and culture<br />▪ Impact - Complexity and Scope - Contributes to the definition and development of new processes, standards, or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results. - Typically has responsibility for smaller scope projects. - Manages limited number of projects, including some of moderate complexity. Leads smaller scope projects. - Contributes to local and regional strategy.<br />▪ Nature of Communication - Influences or persuades others within area of immediate responsibility, scope, and level to accept new ideas, approaches, and concepts.<br />▪ Innovation: - Identifies issues; exercises judgment in developing new approaches/solutions and resolving issues within immediate area of responsibility and scope.</p><p><br /><b>Other skills and Abilities</b><br />May require limited supervision. Possess good written, oral communication, interpersonal skills, diplomacy, and presentation skills and customer service.</p><p></p><p><b>Other:</b><br />▪ Excellent knowledge of English is required.<br />▪ Proficient in Microsoft Office applications</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p> </p><p> </p><p><b>Required Skills: </b></p><p> </p><p> </p><p><b>Preferred Skills:</b></p>Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)