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Operate and improve Swisscom’s core banking and banking applications. Support integrations, incident resolution, releases, and technical projects.
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Remote RDQA Clinical Quality Auditor — New Jersey
Conduct GCP audits and corrective-action follow-up for AbbVie, supporting clinical quality and compliance across global operations. Advise business partners on clinical regulations, quality systems, and inspection readiness.
विवरण
- Manage the Clinical audit program, including scheduling, planning, reporting, and audit resolution.
- Maintain alignment with RDQA policies and procedures.
- Help develop and implement the Clinical QA quality system.
- Advise business partners on GCP and clinical quality matters.
- Assess clinical processes through audits and quality-assurance oversight to verify compliance.
- Lead and support the scheduling, planning, and execution of Clinical audits.
- Perform investigator site, process, system, and Affiliate audits.
- Deliver oral and written audit results within established timelines.
- Review and approve Corrective Action Plans and monitor actions through completion.
- Help develop and implement systems and processes that support global quality-assurance requirements.
- Support the maintenance and development of quality standards for Clinical audits.
- Participate in continuous-improvement initiatives and projects.
- Support GCP inspections as needed.
- Provide GCP regulatory guidance and consultation to RDQA and business partners.
- Encourage ongoing education in quality, clinical guidelines, and regulations.
आवश्यकताएँ
- Bachelor’s degree in a physical, life, or health science; a healthcare profession such as nursing or pharmacy; or equivalent experience.
- Three to five years of experience in the biopharmaceutical industry or with a regulatory authority.
- Three to five years of experience in Quality Assurance and/or Clinical Research Development.
- Strong analytical ability and skill in drawing conclusions from presented data.
- Capacity to work effectively and efficiently in a dynamic environment with minimal supervision.
- Working awareness of clinical-trial regulations, including ICH-GCP and the EU Clinical Trial Directive/Regulation, as well as industry best practices.
- Flexibility to adapt to changing assignments and prioritize work effectively.
- Strong project-management, interpersonal, and communication skills.
- Ability to work independently and collaboratively within a team.
- Willingness and ability to travel internationally.
- Availability for travel of up to 40%.
- Equivalent experience may be accepted in place of the stated bachelor’s degree.
लाभ
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance.
- 401(k) plan.
- Short-term incentive programs.
- Equal-opportunity employer benefits and reasonable-accommodation support for eligible applicants.
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