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.
Key Responsibilities Lead the development, implementation, and continuous improvement of the company’s quality management system.
Ensure compliance with GMP and c GMP 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, Power Point) Fluent in English and Mandarin (spoken and written) 5+ years of people management experience 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.
Syst Immune 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.
Syst Immune 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.
Syst Immune is an Equal Opportunity Employer.
We welcome diverse talent and encourage all qualified applicants to apply.
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