Executive Director of Quality Assurance

SystImmune, Inc.; Princeton (NJ); Hybrid; USD 240,000 - 300,000; Full time

Benefits offered by this job

401(k) match

PTO

Holidays

Comprehensive benefits

Job summary

SystImmune, a leading clinical-stage biopharmaceutical company with offices in Princeton, NJ and Bothell, WA, is seeking a meticulous Quality Assurance professional with GCP expertise. The role focuses on ensuring clinical trials comply with ICH-GCP, FDA regulations, and internal policies across the lifecycle.

Hybrid work 2-3 days in the office; requires 10+ years in QA with CAPA, audits, vendor qualifications. Salary range $240,000-$300,000 with a comprehensive benefits package.

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.
• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.

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.

Skills

GCP expertise

Regulatory knowledge

Communication skills

Detail oriented

Education

Bachelor's degree in life sciences

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

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. 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 Bothell, Washington.

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 - $300,000 per year based on skills, education, and experience relevant to the role.

SystImmune is a leading and 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 offers an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.