Sr Director Quality Assurance - GCP

Redmond, WA

Full-time $240,000.00 - $280,000.00

Posted 06/06/2024

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.

For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa.

Additional ways to apply

Preferred Skills

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Job ID: MM41-1805616

Employees will receive paid leave to the extent required by state or local law. This job was first posted by CyberCoders on 06/06/2024 and applications will be accepted on an ongoing basis until the position is filled or closed.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.