Manager/Sr. Manager, R&D Quality
Your Impact:
Poseida is looking for a pragmatic, collaborative and highly motivated individual with good time management and problem-solving skills, and flexibility to adapt to changes. In this position, you will have an opportunity to learn and advance in your career and be part of the company whose mission is to develop and bring new and exciting therapies to help the life of patients with cancer and rare diseases. Position
Summary:
The R&D Quality Manager is part of the small team providing GCP and GLP quality and compliance support to Poseida programs, and to Clinical Trial and R&D teams. The incumbent will be responsible for the development and execution of study level audit plans, conducts internal and external audits, identifies, and communicates compliance risks. Works cross-functionally and CRO/vendor to monitor quality issues and support addressing quality and compliance matters as assigned. Responsibilities may include but are not limited to:
Serve as the Clinical Quality Lead for the assigned clinical studies and provides GCP compliance interpretation, consultation, and other support to assure GCP activities are conducted according to GCP Guidelines, applicable regulations, protocols and company policies and procedures Develop strategic risk-based audit plans for assigned studies and manage the audit programs Support and perform GCP/GLP audits (e.g., investigational sites, vendors providing services in support of clinical and non-clinical studies), GCP system audits, audits of regulatory documents (e.g., clinical study report, regulatory submissions, as necessary) Oversee the timely audit conduct, reporting, reviewing and close out according to Poseida procedures Perform or lead the vendor qualification/re-qualification, and maintain the list of qualified clinical and non-clinical vendors Drive the resolution of quality issues and associated corrective action plans Provide QA review of protocols, informed consent forms (ICF) and investigational brochure as assigned Provide QA inputs during the creation/revision of clinical procedural documents and review the documents for GCP compliance Maintain contemporary knowledge of and further develop expertise in regulations and ICH Guidelines requirements pertaining to GCP and GLP Support inspection readiness activities Requirements Requirements, Knowledge, Skills and Abilities:
Bachelor's or Master's degree in a scientific or health sciences discipline or a related field with 5
years (8
years for Sr. Manager level) of relevant work experience in the Pharmaceutical/Biotechnology industry and at least 3 years in quality or compliance. An equivalent combination of education and experience may be considered. Strong working knowledge of FDA regulations and ICH guidelines with focus on GCP and GLP Experience in conducting or leading audits and managing quality and GCP compliance issues Demonstrated problem-solving and critical thinking skills Detail oriented and demonstrated strong verbal and written communication skills Demonstrated ability to work independently and effectively in a dynamic, complex and fast-paced team environment Track record of strong personal performance combined with strong interpersonal and organizational skills Travel will be required, up to 30% of the time 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Poseida is looking for a pragmatic, collaborative and highly motivated individual with good time management and problem-solving skills, and flexibility to adapt to changes. In this position, you will have an opportunity to learn and advance in your career and be part of the company whose mission is to develop and bring new and exciting therapies to help the life of patients with cancer and rare diseases. Position
Summary:
The R&D Quality Manager is part of the small team providing GCP and GLP quality and compliance support to Poseida programs, and to Clinical Trial and R&D teams. The incumbent will be responsible for the development and execution of study level audit plans, conducts internal and external audits, identifies, and communicates compliance risks. Works cross-functionally and CRO/vendor to monitor quality issues and support addressing quality and compliance matters as assigned. Responsibilities may include but are not limited to:
Serve as the Clinical Quality Lead for the assigned clinical studies and provides GCP compliance interpretation, consultation, and other support to assure GCP activities are conducted according to GCP Guidelines, applicable regulations, protocols and company policies and procedures Develop strategic risk-based audit plans for assigned studies and manage the audit programs Support and perform GCP/GLP audits (e.g., investigational sites, vendors providing services in support of clinical and non-clinical studies), GCP system audits, audits of regulatory documents (e.g., clinical study report, regulatory submissions, as necessary) Oversee the timely audit conduct, reporting, reviewing and close out according to Poseida procedures Perform or lead the vendor qualification/re-qualification, and maintain the list of qualified clinical and non-clinical vendors Drive the resolution of quality issues and associated corrective action plans Provide QA review of protocols, informed consent forms (ICF) and investigational brochure as assigned Provide QA inputs during the creation/revision of clinical procedural documents and review the documents for GCP compliance Maintain contemporary knowledge of and further develop expertise in regulations and ICH Guidelines requirements pertaining to GCP and GLP Support inspection readiness activities Requirements Requirements, Knowledge, Skills and Abilities:
Bachelor's or Master's degree in a scientific or health sciences discipline or a related field with 5
years (8
years for Sr. Manager level) of relevant work experience in the Pharmaceutical/Biotechnology industry and at least 3 years in quality or compliance. An equivalent combination of education and experience may be considered. Strong working knowledge of FDA regulations and ICH guidelines with focus on GCP and GLP Experience in conducting or leading audits and managing quality and GCP compliance issues Demonstrated problem-solving and critical thinking skills Detail oriented and demonstrated strong verbal and written communication skills Demonstrated ability to work independently and effectively in a dynamic, complex and fast-paced team environment Track record of strong personal performance combined with strong interpersonal and organizational skills Travel will be required, up to 30% of the time 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
