What are the responsibilities and job description for the Associate Director, GXP Quality Systems position at BLOSSOMHILL THERAPEUTICS INC?
Job Summary:
The Associate Director, GxP Quality Systems is responsible for the development, implementation, and ongoing management of the company’s Quality Management System (QMS) supporting GxP activities. This role ensures that quality processes and systems effectively support compliant operations across clinical, regulatory, and operational functions.
Key Responsibilities:
GXP Quality Management System Oversight
- Develop, implement, and maintain the company’s GxP Quality Management System supporting clinical development and broader GxP activities.
- Provide governance for core quality processes including document management, training administration, and quality event processes (e.g., deviations, change control, and CAPA).
- Ensure quality policies, procedures, and standards support compliance with applicable GXP regulations, guidelines, and other relevant regulatory requirements.
- Maintain oversight of electronic quality management systems (eQMS), including administration, configuration, and alignment with company quality processes.
- Partner with functional Quality leads to ensure quality processes are implemented consistently across GxP activities.
Quality Process Governance and Continuous Improvement
- Monitor the effectiveness of quality processes and drive continuous improvement initiatives within the QMS.
- Develop and maintain quality metrics and dashboards to evaluate compliance trends and system performance.
- Prepare quality system reports and compliance summaries for review by senior management.
Cross-Functional Collaboration
- Provide guidance and training to internal teams on quality system processes and expectations.
- Collaborate with clinical operations, regulatory, CMC, and other functional teams to support implementation of quality processes.
- Represent Quality Systems on cross-functional initiatives related to quality process development or improvement.
Support of GXP Quality Activities
- Collaborate with the GMP and GCP Quality functions to support quality oversight of manufacturing and clinical development activities.
- Support the development and maintenance of clinical quality procedures and standards.
- Assist with inspection readiness activities related to manufacturing, clinical trials and regulatory inspections.
- Contribute to quality initiatives that strengthen compliance across clinical programs and GXP vendors.
Additional Quality Responsibilities
- Support internal and external audit programs, including preparation, coordination, and follow-up activities.
- Participate in vendor qualification and oversight activities where quality system processes are involved.
- Contribute to broader GxP Quality initiatives across the organization.
Qualifications:
- Bachelor’s degree in a scientific discipline or related field.
- 6 years of progressive experience in Quality Assurance or Quality Systems within the pharmaceutical or biotechnology industry.
- Experience supporting clinical development programs and familiarity with GMP and/or GCP regulations and guidelines.
- Experience working with electronic Quality Management Systems (e.g., Veeva, TrackWise, or similar platforms).
- Experience working in a virtual or outsourced development environment is preferred.
- Strong organizational, analytical, and problem-solving skills.
- Excellent written and verbal communication skills.
AAP/EEO Statement:
The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Recruiters and Agencies:
BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHills’ employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.
Salary : $167,800 - $191,000