Sr. Director Quality Assurance - Good Clinical Practice (GCP)
This position requires a hybrid working model, with expectations of being in office 2-3 days a week at either the headquarters of Redmond, WA or an office in central New Jersey, which location is being determined.
Company Overview:
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.
Job Summary:
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.
Key Responsibilities:
- Compliance Oversight: Ensure that all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH-GCP), and applicable laws.
- Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
- Audits and Inspections: Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
- Training and Education: Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders
- Risk Management: Collaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies to address them effectively.
- Quality Management System (QMS): Maintain and enhance SystImmune’s QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
- Corrective and Preventive Actions (CAPA): Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
- Vendor Oversight: Evaluate and monitor the performance of third-party vendors, including contract research organizations (CROs) to ensure compliance with GCP requirements.
- Continuous Improvement: Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP-related processes and procedures.
Qualifications:
- 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.
- Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
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.
The hiring pay range for this position is $240,000 - $280,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a 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, plus 11 paid holidays and MORE.
SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]
