This role will start off as a parttime contract then move into full time 1-2 months in.
We are a dynamic clinical-stage bio-pharmaceutical company located in Redmond, WA. Our mission is to revolutionize cancer treatment by developing breakthrough-therapeutic multi-specific antibodies and ADCs. With eight assets in ongoing clinical trials and a robust preclinical pipeline, we are committed to advancing innovative therapies from discovery through IND-enabling stages.
We are looking for a meticulous and detail-oriented Quality Assurance candidate with expertise in Good Clinical Practices (GCP) to join the team. This person will be responsible for ensuring that all clinical trials and research activities adhere to regulatory requirements, industry standards, and internal polices related to GCP. This role plays a crucial part in maintaining the integrity, reliability and ethical standard of our clinical research endeavors.
What You Will Be Doing
- Ensure that clinical trial activities comply with GCP guidelines, international regulations (ICH-GCP) and applicable laws.
- Develop and deliver internal training programs on GCP principles, regulations, and best practices and relevant stakeholders.
- Investigate deviations, mom-compliance, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
- Evaluate and monitor the performance of third-party vendors, including CROs to ensure compliance with GCP requirements.
What You Need
- Bachelor's degree in life science, pharmacy, nursing or related field.
- Minimum of 10 years of quality assurance experience within pharma/biotech industry with a focus on GCP compliance.
- SEM in GCP guidelines, ICH-GCP, FDA regulations
- experience conducting GCP audits, inspections, and vendor qualification/assessments.
- Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional.
Benefits
Comprehensive benefits package including:
- 100% paid employee premiums for medical/dental/vision, also
- STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years,
- 15 PTO days per year,
- sick leave,
- 11 paid holidays and MORE.
Email Your Resume In Word To
Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:
michael.montevideo@cybercoders.com
- Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : MM41-1805616 -- in the email subject line for your application to be considered.***
Michael Montevideo - Executive Recruiter
Applicants must be authorized to work in the U.S.
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