Description
Your Impact:
You will be an integral part of a Quality Team that is dedicated, agile, and collaborative. In this on-site role, you will have a direct impact in supporting operations that is committed to delivering quality products to our clinical patients. Your talents and expertise will directly contribute to Poseida's passion - developing innovative therapies with the capacity to cure. You will foster cross-functional collaboration while developing your own career path. If you are an individual that is driven to make a difference, have a strong work ethic, and you want to be a part of an exciting bigger picture, the Poseida Quality team welcomes you!
Position Summary:
Poseida is seeking an exceptional candidate to join our Quality team in San Diego, CA. The Sr. Auditor is an on-site role that will lead the compliance and GMP audit program for Poseida. This role will be integral to the overall compliance programs at Poseida by leading the GMP audit function, overseeing supplier qualification, performing internal and external audits, and leading/hosting audits conducted at the Poseida site.
Responsibilities include, but are not limited to:
- Providing compliance audit expertise, leadership, oversight and planning for the Poseida Quality Auditing function, with emphasis on GMP and Quality audits that may impact GMP operations at Poseida.
- Developing the overall audit plan, performing associated risk assessments and leading the GMP audit function for Poseida.
- Providing direct support during regulatory inspections and internal audits and ensuring that Poseida inspection readiness is maintained to facilitate inspection execution.
- Coordination of regulatory and partner audits, including both execution and development of audit corrective action plans.
- Maintain inspection readiness content, including building and maintaining a Quality Plan for inspection readiness, to ensure quick access to materials in the event of inspection or audit.
- Collaborating with Supply Chain, Operations and other team members and external suppliers pertaining to supplier audits.
- Leading supplier, contracted service providers and internal audits, conducting the audit planning and scheduling, audit scope development and execution of the audit including opening/closing activities and report preparation.
- Communicating audit results to management and auditees through written audit reports.
- Leading post-audit activities, assessing audit findings and assist the business in identifying and developing CAPAs/ remediation options and prioritizing their closure.
- Updating Supplier Audit list including support of the approved supplier lists.
- Other audit / compliance functions as required.
Requirements, Knowledge, Skills and Abilities:
- Expert knowledge of auditing (internal, external, and inspection execution support) in a cGXP manufacturing environment.
- Bachelor’s degree in Life Sciences discipline with 12 plus years of experience in a GXP setting, 8 in a quality role.
- Strong ability to write audit plans, audit reports, corrective actions, SOPs, work instructions and other Quality audit documents.
- Demonstrated ability to work in a fluid, dynamic and fast-paced environment.
- Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to timelines.
- Detail-oriented with exceptional written and verbal communication skills.
- Complete proficiency in Excel, PowerPoint and Word.
- Demonstrated ability to work independently, within prescribed guidelines, or as a team member.
- Exemplifies team leadership, adept problem-solving, creative and critical thinking and project planning abilities.
- Advanced knowledge and competence in compliance requirements and GMP requirements for biologics.
- Experience with cell-based therapies a plus.
- Up to 25% travel required for auditing.
Senior Auditor Pay Rate: $146,000 to $183,000
The final pay 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 with the industry, education, geographic location, etc.
Who We Are and What We Do:
Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients’ lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.
At Poseida we put people first. Our team is passionate about improving patients’ lives through innovation. See what our team has to say about our culture:
“My favorite part about Poseida is all the people that I get to work with. Everyone is so passionate about what we’re doing here and there’s so much camaraderie. It feels like one big enthusiastic family.”
“My favorite part about working at Poseida is the amazing culture and working environment. Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude.”
As we advance our compelling pipeline, there are endless opportunities for impact and growth. We encourage you to apply today!
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