Executive Director of Quality Assurance
About The Position
SystImmune Inc. is a dynamic clinical-stage bio-pharmaceutical company headquartered 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 seeking a meticulous and detail-oriented Quality Assurance candidate with expertise in Good Clinical Practice (GCP) to join our team. The ideal person will be responsible for ensuring that all clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies related to GCP. This role plays a crucial part in maintaining the integrity, reliability, and ethical standards of our clinical research endeavors.
Requirements
- Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
- Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
- SME in GCP guidelines, ICH-GCP, FDA regulations, and other relevant regulatory requirements.
- Experience conducting GCP audits, inspections, and vendor qualifications/assessments.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
- Detail-oriented mindset with a proactive approach to problem-solving and decision-making.
Nice To Haves
- Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
Responsibilities
- Ensure that all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH-GCP), and applicable laws.
- Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
- Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
- Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders.
- Collaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies to address them effectively.
- Maintain and enhance SystImmune’s QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
- Investigate deviations, non-compliances, 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 contract research organizations (CROs) to ensure compliance with GCP requirements.
- Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP-related processes and procedures.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional development and career advancement.
- Work in a dynamic and collaborative environment at the forefront of clinical research.
- Contribute to meaningful projects that have the potential to improve patient outcomes and advance medical science.
- 100% paid employee premiums for medical/dental/vision.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
