What are the responsibilities and job description for the Senior Director of Quality Assurance position at Terremoto Biosciences, Inc?
Position Summary:
The Senior Director of Quality Assurance is responsible for the quality oversight, strategy, and management of GxP-related activities; collaborate cross-functionally with the various GxP departments to ensure compliance at the company, the company’s approved vendors and clinical sites; and strategize to advance overall company quality and compliance
Key Responsibilities:
- Based on gap analysis, create, monitor, and implement a quality system.
- Lead QA initiatives for quality and continual improvement.
- Accountable for GxP compliance, including GCP compliance of clinical trials, GMP/GDP compliance of drug substances and drug products, and GLP compliance of non-clinical studies.
- Identify compliance risks and implement risk mitigation measures when applicable.
- Ensure inspection readiness of company and company’s vendors and clinical sites.
- Oversight of vendor qualifications, including external GxP audits and audit assessments.
- Develop, revise, implement, and adhere to QA department policies and procedures.
- Provide interpretation to GxP departments on regulations, guidelines, compliance status, and policies and procedures.
- Manage the quality system at the company, including training, controlled documents, risk management, CAPA, change control, deviations, serious breaches, drug substance and drug product disposition, complaints, and recalls.
Qualifications:
- Previous small molecule drug experience is a plus.
- Established working knowledge of GxP and other applicable US and international regulations.
- Quality Assurance experience in all phases of clinical trials.
Education:
- Bachelor’s or master’s degree in life science field or equivalent.
- 15 years pharmaceutical industry experience with a minimum of 10 years in Quality Assurance.
* The anticipated salary range for candidates who will work in South San Francisco, CA is $260,000 to $275,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Salary : $260,000 - $275,000
