Job Description

We are looking for an experienced Pharmaceutical Quality Assurance professional to provide oversight of analytical testing activities for sterile combination products. This role will report to the Sr. Director of GMP Quality Assurance. The ideal candidate will be detail-oriented, self-motivated, and capable of adapting to changing priorities while effectively managing workloads to meet project deadlines.

Responsibilities:

• Provide Quality oversight of analytical method transfers and qualification/validation such as review and approve testing protocols, method validations, and reports for accuracy and compliance.
• Provide Quality oversight of product release and stability testing.
• Manage quality oversight for products manufactured, released, and tested at CMOs/CLOs.
• Ensure CMOs and CLOs comply with regulatory standards, company requirements, and Quality Agreements.
• Provide Quality oversight of out-of-specification (OOS), deviations and investigations, ensuring corrective and preventive actions (CAPAs) are implemented both at CMOs/CLOs and internally.
• Evaluate CMO Change Requests and contribute to the design, development, and continuous improvement of Quality Assurance systems and programs to support quality activities at CMOs/CLOs and within Vera.
• Participate in preparation for and execution of regulatory audits. Ensures audit observations related to functional area are addressed appropriately and completed on schedule.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Contribute to the definition and implementation of quality standards, specifications, methods, systems, and metrics for both clinical and commercial quality operations.
• Lead or collaborate with cross-functional project teams to achieve both quality and business objectives.
• Support product release and manage product complaint processes.
• Available for 5-15% travel, both domestically and internationally, as required.

Qualifications:

• Minimum of BA/BS degree.
• 8+ years of experience in quality oversight of analytical method transfer, qualification, and validation, or in a comparable role.
• Strong knowledge of current Good Manufacturing Practices (cGMP) regulations and industry standards.
• Experience in Quality System, specifically generation/revision of SOPs.
• Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Strong problem-solving skills, with a demonstrated ability to innovate and influence peers to achieve quality objectives.
• In-depth familiarity with biologics product testing and ICH guidelines for analytical methods is required.

Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $144,000 - $214,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

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We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

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