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Senior Local Compliance Specialist - 2406176308W
Description
We are looking for a driven Senior Local Compliance Specialist to join our Clinical Operations team in Belgium and The Netherlands but also supporting the local compliance team in The Nordics (Sweden, Denmark 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 SOP's, 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 Compliance Specialist will collaborate with the Compliance Managers, the Country Head, the Clinical Research Managers and the local teams in the whole 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 of /- 215 people eager to deliver and helping to improve the lives of millions of patients.
Principal Responsibilities:
Quality and Compliance Oversight: Proactively monitor compliance risks and metrics and install timely mitigation actions; Take ownership 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; lead preparation and oversight of inspections and audits and timely implementation of CAPA's; leads or provides input in process improvement initiatives. Takes ownership in writing business processes and/or Standard Operating Procedures
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 for complex situations to ensure timely resolution of issues.
Local regulatory intelligence: perform impact assessments of new/revised local regulations in countries within the Northern European cluster 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 local compliance meetings in the Northern European cluster.
Assume additional responsibilities or special initiatives such as 'Champion', ''Subject Matter Expert' or 'Business Process Owner', for local and cluster processes.
Qualifications
Education and Experience Requirements:
BA/BS degree in Life Sciences or related scientific field (or 4-6 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 confirmed 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
Proven project management skills
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, English and French (for Belgian candidates)
About Johnson & Johnson
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/.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations Europe/Middle East/Africa-Netherlands-North Brabant-Breda
Organization Janssen Pharmaceutica N.V. (7555)
Job Function Clinical Quality
Req ID: 2406176308W