We are seeking an experienced Head of Quality to lead our company’s pharmaceutical quality management function. This role is responsible for establishing, improving, and maintaining a robust GMP-compliant Quality Management System (QMS) to ensure product quality, regulatory compliance, and operational excellence across the organization.
Lead the development, implementation, and continuous improvement of the company’s quality management system.
Ensure compliance with GMP and cGMP standards and regulatory requirements.
Oversee all quality-related activities across QA, QC, and Validation functions.
Establish and maintain quality management procedures, production control procedures, and standard operating procedures (SOPs).
Approve all quality-related changes and manage deviations, complaints, and adverse event investigations.
Oversee qualification and validation activities, including review and approval of protocols and reports.
Evaluate and approve materials and manage supplier quality performance.
Establish and maintain a robust quality training system, ensuring all relevant personnel receive appropriate initial and ongoing training.
Collaborate cross-functionally to support continuous improvement and inspection readiness.
Qualifications
Education:
Bachelor’s degree or higher in Pharmacy, Biomedical Science, or related field
Experience:
10+ years of experience in pharmaceutical production and quality management, including at least 5 years in commercial-scale operations
Proven experience leading GMP certification projects (FDA or EU certification preferred)
Skills & Competencies:
Deep understanding of pharmaceutical regulations and quality systems
Excellent leadership, communication, and cross-functional collaboration skills
Strong analytical and decision-making abilities
Proficient in Microsoft Office (Word, Excel, PowerPoint)
Compensation and Benefits:
The expected base salary range for this position is $200,000 - $300,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of 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.
We offer 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.
Located in Redmond WA, founded in 2014, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
