Manager/Senior Manager, Quality Management Systems

Description

Your Impact:

You will be an integral part of a friendly Quality Assurance (QA) 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 Assurance team welcomes you!

Position Summary:

Poseida is seeking an exceptional candidate to join our Quality team in San Diego, CA. This is an on-site role that will lead the enhancement and maintenance of Poseida’s Quality Systems, with primary focus on the Electronic Data Management System (EDMS), Document Control function and our GxP Training program to ensure compliance with regulatory requirements, while maintaining the flexibility to support Poseida’s specific needs to remain nimble. This role will be integral to the overall GxP Quality system including processes such as Change Control, Deviation, CAPAs, Training, and Document Control, as well as the tracking/trending/reporting of Quality System Metrics. This position will work closely with all GxP partners (e.g. QA, QC, Manufacturing, Calibration, Validation, Supply Chain, Facilities, Clinical, etc.).

Responsibilities include, but are not limited to:

• Responsible for overseeing Document Control activities for documents used in GxP operations (includes manufacturing, clinical and product quality related documents) and archiving activities
• Lead the GxP Training Program and perform/oversee training for Quality System related topics (e.g. annual GMP training, Change Control, Deviation and CAPA)
• Further develop enhancements to existing training programs (e.g. train the trainer) and training matrices
• Work directly with Change Control, Deviation, MRB and CAPA owners to ensure completion of the quality record within the specified timeline and to ensure conformance of the content to written procedures
• Responsible for the management of the ComplianceWire Learning Management System (LMS) and Qualio (EDMS)
• Lead continuous improvement efforts for events within the EDMS and LMS (e.g. Change Control, Document Change Request, CAPA, Deviation, MRB and Training)
• Work directly with document owners to ensure periodic review of documents meet the respective target due date
• Support EDMS and LMS systems new releases impact assessment and system update validation documentation.
• Create and revise procedures including SOPs, policies, forms, templates and reporting tools
• Generate quality metrics, identify, and communicate trending of Quality system metrics to leadership 
• Provide EDMS and LMS onboard training of new hires
• Provide real time support to users on EDMS and LMS
• Responsible for maintaining the document vault and management of Iron Mountain archival and retrieval processes
• Represent the Quality System function at inter and intra- departmental meetings and serve as the subject matter expert for Quality system requirements
• Support internal and external audits and Agency or partner audits
• Lead/Support Quality initiatives driving the culture of a Quality Mindset
• Review and approve paper-based quality documentation and quality records within the EDMS
• Align daily actions with department goals and company culture 
• Actively promote teamwork across all functions with focus on our patients being the top priority
• Drives, fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product
• Provide development opportunities for direct reports

Requirements

 Requirements, Knowledge, Skills and Abilities:

• Manager, Quality Management Systems: Bachelor’s degree in Life Sciences discipline with 5 plus years of experience in a GXP setting (an equivalent combination of education and experience may be considered) 
• Senior Manager, Quality Management Systems: Bachelor’s degree in Life Sciences discipline with 8 plus years of experience in a GXP setting (an equivalent combination of education and experience may be considered)
• Expert knowledge of Quality Management Systems in a cGXP manufacturing environment
• Strong ability to write SOP’s, work instructions and other Quality System documents
• Advanced ability to develop training materials and train employees
• Demonstrated ability to work in a fluid, dynamic a