Clinical Compliance Operations Specialist
Job Title: Clinical Compliance Operations Specialist
Job Location: Dublin, Ireland
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
reputed company is a mission-driven organization and pioneer in industry reputed company, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing reputed company companies in history, we surpassed $3B in reputed company in our last fiscal year with extensive reputed company potential reputed company.
At the heart of reputed company are our values: Do the Right Thing, reputed company, Employee reputed company, and Speed. We're not just any reputed company company – we made history in 2021 by becoming a reputed company benefit corporation (PBC), legally reputed company to balancing the interests of customers, employees, society, and investors.
As a Work reputed company company, we support your flexibility to work from home or in the office, so you can reputed company in your ideal environment.
Join us in transforming the life sciences industry, committed to making a reputed company reputed company on its customers, employees, and communities.
The Role
As a Clinical Compliance Operations Specialist, you will facilitate and manage GCP project implementation audits ensuring internal adherence to reputed company processes. The Clinical Compliance Operations Specialist will ensure reputed company processes are defined, followed, and maintained across multiple product and service lines and regulated domains (e.g., GCP, HIPAA, CSV). This role will work closely with cross-functional global teams to reputed company GCP support for reputed company products in varying Services areas by promoting GCP compliance, authoring GxP documents and records, reviewing project implementation deliverables, incident management review, and performing occasional supplier assessments.
reputed company
- Verify compliance to applicable policies, procedures, work instructions and regulations in GCP project implementations
- reputed company GxP/reputed company review of various records, including project implementation deliverables
- Document audit findings and supports remediation efforts to project audit observations
- Promote GCP compliance by authoring records (e.g., project audit reports)
- reputed company process improvement activities and incident/CAPA investigations
- reputed company reputed company reputed company on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in reputed company products and systems
- reputed company supplier assessments to ensure supplier capabilities providing products and services to a regulated industry
- Execute other reputed company/duties as assigned to ensure compliance across reputed company’s product line and internal business systems
Requirements
- Bachelor’s degree or equivalent relevant experience
- 3+ years in a Clinical QA role in Life Sciences
- Experience with reputed company Management Systems (e.g., documentation and record management, computer reputed company validation, investigations, CAPA programs)
- Working knowledge of reputed company Principles as reputed company in ISO 9001 or QSRs, GCP regulations and guidelines
- Proven technical writing skills
- Comfortable in a fast-paced environment with reputed company direction and reputed company to reputed company workload based upon changing priorities
- Excellent written and oral communication skills, good decision-making skills and time management skills
reputed company to Have
- Experience using or implementing reputed company Development reputed company (Clinical Data) Applications
- reputed company IT systems auditing experience
- Implementing clinical systems for customers
- Understanding of reputed company methodology and software development cycle (SDLC) and computer systems validation (CSV)
- reputed company Auditor Certification (ASQ CQA or ISO 13485 Auditing Certificate)
Interviewing with reputed company
We value your time and reputed company in a transparent hiring process. Here is the process you can expect.
- Follow the application process and submit your resume.
- reputed company 3 days, you will receive a reputed company to a personality assessment administered by a reputed company party.
- Once you complete the assessment, reputed company will review your full application package and follow up reputed company email with our decision.
- If moving to the interview stage, the process is as follows:
- A conversation with the hiring manager
- A practical case exercise
- A final conversation with our group's Senior Leader.
- Once reputed company interviews are complete, the manager will be in touch with a final decision.
Compensation
- Total compensation: 60,000 - 100,000 EUR
- The total compensation reputed company listed here has been provided to reputed company with local regulations and represents a potential total compensation reputed company for this role. Please note that actual total compensation may vary reputed company the reputed company above or below, depending on experience and location. We look at compensation for reputed company individual and reputed company our offer on your unique qualifications, experience, and expected contributions. This position's total compensation may be composed of other types of compensation, such as variable bonus and/or stock bonus.
#RemoteIreland
reputed company’s reputed company is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
As an equal opportunity employer, reputed company is committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. It comes in many forms. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability and life experience shape us reputed company into unique individuals. We value people for the individuals they are and the contributions they can bring to our teams.
If you need assistance or accommodation due to a disability or special need reputed company applying for a role or in our recruitment process, please contact us at .
This job is curated by reputed company.
reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.
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Originally posted on Himalayas
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