Executive Director, Clinical Quality Assurance - Oncology Biotech

SystImmune; Princeton (NJ); Hybride; USD 240 000 - 300 000; Plein temps

Avantages offerts par ce poste

100% paid employee premiums

STD/LTD

401(k) with company match

Vesting schedule 5 years

15 PTO days per year

Sick leave

11 paid holidays

Résumé du poste

SystImmune is seeking a meticulous Quality Assurance professional with deep GCP expertise to oversee clinical trial compliance and regulatory adherence. The role demands experience auditing, CAPA, QMS, and cross-functional collaboration to uphold data integrity and patient safety across trials.

Ideal candidates will hold a life sciences-related degree, 10+ years in pharma/biotech QA with GCP focus, and relevant certifications. Hybrid work in Princeton or Redmond with strong growth potential.

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

Responsabilités

• 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

Connaissances

GCP compliance

ICH-GCP

FDA regulations

Audit management

Vendor oversight

CAPA investigations

QMS implementation

Training development

Cross-functional collaboration

Formation

Bachelor's degree in life sciences, pharmacy, nursing, or related field

Description du poste

This position requires a hybrid working model, with expectations of being in office 2-3 days a week at an office in Princeton, New Jersey (preferred location) or Redmond, Washington.

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
• 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 - $300,000 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.