Senior Manager, Quality Assurance, Drug Product

Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.

Minimum of 8 years of experience in quality assurance, batch record review, manufacture, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry. Other combinations of education and/or experience may be considered.

Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards.

Knowledge and experience in Risk Management principles.

Experience in both clinical and commercial parenteral drug product required.

Strong Management and process improvement skills.

The compensation package will be competitive and includes comprehensive benefits and an equity component.

$166,000 – $193,000 (SF Bay Area). Salary ranges for non-California locations may vary.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Provide Quality Assurance oversight of Contract Manufacturing Organizations.

Represent QA at internal cross functional team meetings and at Joint Project Team meetings.

Lead batch disposition activities such as review of executed batch records, environmental monitoring and quality control data.

Review and approve documentation such as master batch records, deviations, risk assessments, change controls, and CAPAs.

Lead deviation and product complaint investigations

Drive resolution of quality performance issues with the contract manufacturer.