Senior Local Compliance Specialist

Breda - Netherlands

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Beerse Antwerp Belgium Breda Netherlands

Job Description:

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 are looking for a driven Senior Local Compliance Specialist to be located in Breda the Netherlands.

In this role you will join our Compliance team in Belgium and The Netherlands but also supporting the local compliance team in The Nordics (Sweden Denmark Norway and Finland). You will contribute to a coordinated and comprehensive local quality and compliance approach to ensure our clinical trials will be delivered to the highest quality standards and are following all applicable SOPs laws and regulations. Our new colleague should be flexible persistent and able to work independently. We are seeking to hire a strong communicator a team player and someone with analytical skills with quick learning and problem-solving abilities. The Senior Local Compliance Specialist will collaborate with the Compliance Managers the Country Head the Clinical Research Managers and the local teams in the Northern European cluster carrying out the clinical trials consisting of Local Trial Managers (LTM) Site Managers (SM) and Clinical Trial Assistants (CTA). You will be part of a hardworking enthusiastic and committed team to deliver and helping to improve the lives of millions of patients.

Key Responsibilities:

Compliance Oversight: Proactively monitor compliance risks and metrics and install timely mitigation actions; Contribute in implementing local quality plans; Perform on-site compliance monitoring visits supervise progress and confirm efficiency of remediation plans and conduct QC checks on trials and processes; support preparation and oversight of inspections and audits and timely implementation of CAPAs; leads or provides input in process improvement initiatives.
Onboarding and consultation: support onboarding of new hires; coordinate workshops trainings and lessons learned on local and Northern European cluster level to increase compliance awareness. Be the go-to person for risk management and provide advice to ensure timely resolution of issues.
Local regulatory intelligence: perform impact assessments of new/revised local regulations and provide clear and timely guidance to the teams. Keep local intelligence up to date.
Collaboration with business quality: support in local supplier assessments assist with annual due diligence update certification and training of local suppliers.
Co-host cluster and regional compliance meetings.
Assume additional responsibilities or special initiatives such as Champion or Subject Matter Expert.

Qualifications

Education and Experience Requirements:

BA/BS degree in Life Sciences or related scientific field (or minimum 4 years equivalent experience).
A minimum of 3 years of previous pharmaceutical industry experience is required with at least 2 years of GxP experience within clinical research and/or quality assurance. Other relevant working experiences and skills may be considered by the hiring manager. Experience in phase 1 2 3 clinical trials is a plus.
Good working knowledge and proven understanding of GCP local laws and regulations
Developed knowledge of business processes and practices
Ability to present in a clear and concise way - strong communication skills
Strong interpersonal and negotiation skills and ability to empower colleagues and stakeholders
Real diplomate that can understand impact and complexity of the situation with the ability to create win-win situations
Willingness to engage with Authorities and key site staff
Proficient in Dutch and English

Required Skills:

Preferred Skills:

Audit Management Business Alignment Business Behavior Business Savvy Clinical Research and Regulations Clinical Trials Operations Coaching Collaborating Compliance Management Data Analysis Data Compilation Escalation Management Goal Attainment Internal Controls Problem Solving Process Oriented Quality Control (QC) Quality Management Systems (QMS) Quality Standards

Required Experience:

Senior IC