Vera Therapeutics, Inc.

Senior Manager, Quality Assurance

Brisbane, CA · Senior

Sponsorship not specified$140k-$190kDetected 9 days ago

Product ManagementNegotiationGMPFDA RegulatoryCommunicationProblem SolvingGxP

About the role

The Senior Manager, Quality Assurance (QA), will report to the Director, QA Drug Substance and is primarily responsible for QA function for Cell Bank and Drug Substance (DS).

Support the oversight of the quality and compliance, primarily cell bank and biologics DS manufacturing.
Support implementation of strategies and tactics to promote and maintain GxP compliance.
Provide quality support on tech transfers.
Liaise with CMO Quality partners to communicate QA policy and procedures.
Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
Provide quality support for validations including process validation, shipping validation, cleaning validation, etc.
Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
Participate in Quality Agreements negotiation with external partners.
Support product lifecycle and continued process verification.

Minimum 6+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
Minimum 6+ years in a GMP QA role, and preferably direct work experience in either Manufacturing or QC, as well.
Excellent written and verbal communication skills, including demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
Ability to operate in a fast-paced, multi-disciplinary industrial environment.
Bachelor's degree with 10+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field or a Master's degree with 7+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field.
Innovative skills with problem solving and peer influence.
Experience of working with external partners and biologics DS manufacturing.
Strong attention to detail is a must.
Excellent interpersonal, written and oral communication skills.
Outstanding organizational skills.
Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.

Vera Therapeutics was founded in 2016 and is based in Brisbane, California.
At Vera, our values are the cornerstone of our culture and guide how we work together every day.
From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.

This listing is sourced directly from Vera Therapeutics, Inc.'s careers page and normalized into a canonical job model.