GCO EMEA Cluster Compliance Lead

Job Description

The Compliance Cluster Lead is a member of the Regional Compliance Leadership Team as well as the GCO Cluster/Country Management Team. The Compliance Cluster Lead manages and advises the Local Compliance Managers/Specialists in their Cluster/Country and is responsible for performing activities to (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials is implemented and maintained and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson global processes and procedures within their Cluster/Country.

In this role you will act as a single point of contact for the Cluster/Country, ensuring appropriate and timely communication of significant/critical quality and compliance issues and you will participate in process improvement projects, departmental decision-making, recruitment, resource assessments, and end of year performance evaluations.

You will be responsible for your team members' development, including mentoring, coaching and training to meet current and future business needs. You will provide an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.

Principal Responsibilities

Quality and Compliance Oversight Activities

• Proactively supervise compliance risk and ensure mitigation/remediation actions are defined
• Support the aggregation of KQPIs and timely metrics generation and analysis
• Proactively monitor progress and confirm effectiveness of remediation plans, perform special investigations and plan, prepare, conduct and report global/regional QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. Coordinate and support the following risk-based activities in their cluster/country:
• On-Site Compliance Monitoring Visits
• Reviews of Trial Master File, training compliance documentation and other checks per Clinical Risk Management (CRM) Integrated Quality Plan for the trial
• Local QC checks
• Support and advise local and central study teams in root cause analysis of significant observations
• Conduct/oversee timely Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals. Proactively facilitate in-depth analyses that lead to solutions.
• Take a leading role with local and central business partners to facilitate (local) inspections and office audits as needed and collaborate and provide advice in timely CAPA setting and implementation.
• Initiate and lead continuous improvement initiatives that show demonstrable impact to the business and processes.
• Develop and manage cluster/local procedural documents, with multi-functional scope, where applicable
• Process ownership for GCO Compliance specific procedures and active in continuous improvement and training
  
  

Local Onboarding and Consultation

• Support onboarding of new hires and drive/influence onboarding and training best practices globally
• Oversee/manage Cluster/Country workshops to support QMS and compliance awareness, Lessons Learned, etc.
• As a universal GCP SME, independently provide advice for complex situations across multi-functional scope regarding SOP, system and GCP questions.
• Manage risk at the Cluster/Country level, including support on root cause assessment and developing effective actions to mitigate risk.
  
  

Local regulatory intelligence

• Approve/conduct impact assessments of new/revised local regulations, guidance and standards
• Support central functions in ensuring local intelligence is up to date (e.g., RIACs)
  
  

Collaboration with Business Quality

• Actively support LOC Management Review in collaboration with LOC Business Quality partners
• Coordinate and/or participate in quality council and annual Due Diligence update, certification and training of local suppliers
• Ensure appropriate local suppliers assessments are performed
  
  

People Leadership

• Directs local Compliance team responsible for implementing and execution of quality and compliance processes in the cluster/country. Such processes include, but are not limited to
• setting and achieving cluster/country specific Compliance goals in collaboration with the Regional Compliance Leader
• execution of QC checks and activities such as On-Site Compliance Monitoring visits, TMF review, etc. in support of CRM trial oversight and local risk monitoring
• Recruits/hires qualified staff for the department and ensures staff have the education, experience and tools to appropriately function as advisors of Good Clinical Practices (GCP). Provides ongoing mentoring, coaching and development of local Compliance Managers and Specialists in their Cluster/Country. Ensures staff are trained on procedures and systems associated with their assigned tasks. Performs administrative tasks associated with performance reviews, salary administration, and other personnel issues.
• Resolves compliance/regulatory issues with business partners within the Cluster/Country. Must be able to work with a high level of independence and be able to train/coach others with regard to teamwork, interpretation of regulatory requirements and compliance activities, and project management to ensure the timely and accurate completion of quality monitoring activities.
  
  

Must haves: to be considered for this role, please ensure the minimum requirements are evident on your resume

• Bachelor Degree in Science or Arts (BA) or 8-10 years proven experience equivalent is required.
• A minimum of 6 years of previous Pharmaceutical Industry experience, with at least 4-6 years of GxP experience within clinical research and development and/or quality assurance is required.
• Extensive knowledge of the overall drug development process.
• Advanced skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities). Well-developed skills working cross-functionally.
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Leads the translation of data into information and strategies into executable action plans improving the business
• Conflict resolution/management and negotiation skills
• Independently plans, organizes, coordinates, manages and performs assigned tasks
• Experience of the key customers’ business processes and practices
• Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
• Experience with regulatory submissions (NDA, BLA) is an asset;
• Strong personal leadership skills with demonstrated competency collaborating with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences;
• Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
• Demonstrated project leadership skills
• Manages or leads multiple projects, including some considered complex and/or with accelerated priority, beyond immediate country responsibilities in support of regional/global Compliance/GCO projects.
• Demonstrated competence for team leadership and/or people management.
• Individual contributor with leadership ability
  
  

About Janssen, the Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Ready to be part of something great? Don't forget to apply. We want YOU!

Primary Location

Europe/Middle East/Africa-Italy-Lombardia-Cologno Monzese

Other Locations

Europe/Middle East/Africa-Czech Republic, Europe/Middle East/Africa-Greece, Europe/Middle East/Africa-Turkey, Europe/Middle East/Africa-Bulgaria, Europe/Middle East/Africa-Israel, Europe/Middle East/Africa-Romania, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Hungary

Organization

Janssen-Cilag S.A. (formerly Janssen Sp) (7300)

Travel

Yes, 10 % of the Time

Job Function

Clinical Trial Administration

Job Qualifications

We would love to hear from YOU, if you have: