Director, GCP Quality Assurance
Department: Quality Assurance
Location: South San Francisco, California, United States
The selected candidate will have the opportunity to develop the QCP role in a dynamic and collaborative environment. Working with industry leaders in Virology and Microbiome, the candidate will provide GCP leadership and oversight of both the Virology/HBV and Microbiome programs. The individual will work closely with the Assembly Clinical organization and have responsibility for oversight of Clinical trial activities at Assembly, as well as, at CRO and Clinical Sites.
Key Responsibilities include:
- Work with Clinical Development and Clinical Operations to understand clinical demand requirements and ensure alignment with CMC to supply plans and timelines
- Identify and communicate risk to clinical trial and provide recommendations and solutions to Quality and Clinical leadership
- Develop, implement and maintain Assembly Biosciences GCP quality systems
- Conduct audits of internal and external partners to assess compliance with GCP requirements for clinical trial-related activities
- Provide GCP QA oversight of clinical trial-related activities internally, as well as at CROs and Clinical sites
- Perform and manage audits of study sites across active studies
- Provide direct support to the clinical study and develop GCP QA study audit schedule
- Evaluate Clinical and Regulatory documents (e.g. protocols, amendments, Trial Master Files, Informed Consents, final reports SOPs) for adequacy and compliance.
- Develop and train colleagues and external partners in GCP compliance
- Assist with the preparation, coordination, and management of regulatory agency inspections
- Lead major and critical deviations/investigations at CROs
- Lead inspection preparation and management internally and at CROs.
Preferred Qualifications include:
- Bachelor’s degree in biotechnology, science or engineering with 10+ years of related industry experience including significant leadership experience in pharmaceutical Quality Assurance
- Knowledge of the pharmaceutical GCP regulations (e.g. 21 CFR Part 50, 56 and 312 and ICH E6 R2) and their appropriate application for clinical trial material manufacturing
- Experience in developing and improving a Quality System
- Experience with Good pharmacovigilance practices (GVP) desired, but not required
- Excellent interpersonal skills along with verbal and written communication skills
- Ability to work efficiently and cooperatively in a virtual company environment
- Goal oriented with the ability to deliver on timelines and commitments
- Up to 50% travel may be required for this position
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly Bio’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology.
We believe our Microbiome platform represents a best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in mildly to moderately active ulcerative colitis (UC), is currently in a phase 1b clinical trial. This program is part of a broader collaboration we established with Allergan in 2017 for gastrointestinal programs such as UC, Crohn’s disease and Irritable Bowel Syndromes. Our internal pipeline comprises first in class or best in class live microbial biotherapeutic approaches in areas such as oncology, immune mediated and metabolic disorders, and other areas of high medical need.
We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add to our dynamic team of great people who are driven to transform the lives of patients.
Assembly Bio is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and offices in China. Assembly Bio has a strong balance sheet having raised approximately $166 million in July 2018. We are positioned well to build the next phase of the Company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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