Lead Compliance Specialist

Johnson & Johnson; Neuss; Hybrid; EUR 87.000 - 119.000; Vollzeit

Zusammenfassung

A global healthcare company based in Neuss is seeking a full-time Lead Compliance Specialist for the DACH region. This role involves managing compliance risks in clinical trials and ensuring adherence to quality standards. The ideal candidate has a BA/BSc in Life Sciences and a minimum of 4 years experience in the pharmaceutical industry. Proficiency in German and English is required. A range of benefits including an annual bonus and vacation days is offered.

Leistungen

Annual bonus based on performance

Vacation days

Parental leave for a minimum of 12 weeks

Well-being reimbursement

Insurance plans

Qualifikationen

• BA/BSc degree in Life Sciences or related scientific field (or 5-6 years relevant experience equivalent).
• A minimum of 4 years in pharmaceutical industry with at least 3 years GxP experience in clinical research.
• Excellent knowledge of German and English is required.

Aufgaben

• Monitor compliance risks and ensure remediation actions are defined.
• Support onboarding of new hires and lead local compliance training.
• Perform impact assessments of new local regulations.
• Collaborate with business quality for local Management Review.
• Participate in global initiatives as assigned.

Kenntnisse

Knowledge of the overall drug development process

Confirmed site management skills

Ability to translate data into actionable strategies

Excellent communication skills

Conflict resolution and negotiation skills

Ausbildung

BA/BSc in Life Sciences or related field

Tools

Microsoft Office

Jobbeschreibung

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 https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Neuss, North Rhine-Westphalia, Germany

Johnson & Johnson Innovative Medicine (J&J IM) is recruiting for a full-time Lead Compliance Specialist (d,f,m) role for the DACH region (Germany, Austria and Switzerland) to be located in Neuss (J&J IM Germany Headquarter). Remote work options may be considered on a case-by-case basis and if approved by the Company.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The Lead Compliance Specialist will collaborate with the Compliance Manager, the Country Head, and the teams, carrying out the clinical trials on a local level as well as local and global partners. You will chip in to a coordinated and comprehensive quality compliance approach to ensure our clinical trials will be delivered to the highest quality standards and are following all applicable SOP's, laws and regulations. The Compliance Specialist will support that our people are adequately trained and onboarded. You need a flexible attitude and have the ability to work in a constantly evolving environment. We are seeking to hire a teammate, with quick learning and problem-solving abilities as well as with good written and oral communication skills. You will be part of a hard-working, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

Key Responsibilities:

• Quality and Compliance Oversight: Monitor compliance risks and ensure remediation actions are defined. Monitor progress and confirm effectiveness of remediation plans. Plan, prepare, conduct, and report QC checks and compliance assessments such as Compliance Monitoring Visits, reviews of the Trial Master File, local QC checks. Support local and central study teams in root cause analysis of significant observations; support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals. Collaborate with business partners to facilitate local inspections and audits, timely CAPA setting and implementation. Support the local impact assessment of global procedural documents and development and management of associated local procedural documents.
• Local onboarding and consultation: Support onboarding of new hires; lead local workshops, trainings and lessons learned to increase compliance awareness. Provide advice regarding SOP, system and GCP questions. Support handling risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
• Local regulatory intelligence: Perform impact assessments of new/revised local regulations, guidance and standards, and support to install clear and timely guidance to the teams. Keep local intelligence up to date.
• Collaboration with business quality: Support local Management Review and Quality Plans. Support local supplier assessments, annual Due Diligence updates, certification and training of local suppliers.
• Participate in (global) initiatives as assigned.

Qualifications

Education:

• BA/BSc degree in Life Sciences or related scientific field (or 5-6 years relevant experience equivalent).
• A minimum of 4 years of previous pharmaceutical industry experience is required with at least 3 years of current GxP experience within clinical research and development and/or quality assurance.

Experience and Skills:

Required:

• Knowledge of the overall drug development process
• Confirmed site management and project leadership skills gaining robust understanding of GCP, and up-to-date knowledge of local laws and regulations related to clinical research in Germany, Austria and Switzerland, as well as EU regulations
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions; issue investigations, e.g., root cause analysis methods and CAPA development
• Developed skills and knowledge of business processes and practices
• Ability to translate data into information and strategies into executable action plans improving the business
• Ability to empower professional colleagues and partners.
• Conflict resolution/management and negotiation skills.
• Ability to independently plan, organize, coordinate, lead and complete assigned tasks.
• Excellent knowledge of German and English is required.

• Proficient in Microsoft Office applications.
• Highly committed to quality and compliance.
• Possess good written, verbal communication, interpersonal skills, tact, and presentation skills and customer service.

The anticipated base pay range for this position is 87,550 EUR to 118,450 EUR.

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 https://www.careers.jnj.com/en/life-at-jj/employee-benefits/

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Our goal is to offer people with disabilities a workplace that is as barrier-free as possible. We are aware that needs can be very individual. We respond to these and work closely with our representative for severely disabled employees. Severely disabled applicants will be given special consideration if they are equally qualified.

If you wish to include or request support from the company's representative for severely disabled people as part of your application process, please proactively inform the responsible recruiter when you are first contacted by our Talent Acquisition Team – thank you.

Preferred Skills:

• 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)