Olema Oncology
Overview
Associate Director, Quality Systems role at Olema Oncology. Role supports the implementation, business requirements, and maintenance of the Veeva Quality suite of Computerized Systems and potentially AI initiatives. Develop, maintain and deliver training materials on such systems. Collaborate with other GXP functional departments (CMC, Clinical Operations, Supply Chain and Regulatory) to generate metrics and KPIs for continuous improvement and quality management review. This role may be based out of our San Francisco, CA or Cambridge, MA office and will require 20% travel. Responsibilities
Managing and upgrading the electronic quality management processes (eQMS) including modules for: document control, company training management, internal and external audits, vendor management, change control and deviation/CAPA management. Responsibility may additionally extend to Regulatory Information Management Systems (RIMS) and Inspection Management Systems to support Phase 3 clinical programs and transition to commercial manufacturing Serve as a Subject Matter Expert in Veeva Systems and Veeva Administrator to support business needs Liaising between QA, Operations (Regulatory, CMC, Non-Clinical, Drug Safety, Clinical) and IT to define, implement and manage eQMS systems; interactions for the training management will also include People & Culture, Facilities, Legal, and Finance Collaborating with IT and Operations for QMS process/system enhancements and process improvements Authoring, reviewing and, at times, approving policies, procedures, and other related documents for the Quality Management Systems processes at Olema Escalating Quality Management Systems-related issues to management for timely mitigation and resolution Supporting evolution of training materials and employee training execution for Quality Management Systems Supplying Quality Management System support during regulatory inspections with document retrieval functions, inspection logistics oversight and other support as needed Maintaining and managing audit (external and internal) documentation, while acting as a subject matter expert for electronic Quality Management Systems Creating and delivering QMS key performance and quality matrices to QA leadership and Executive management Communicating and promoting a culture of quality and operational excellence at Olema Qualifications
Bachelor’s degree in a scientific field is required; Master’s degree is preferred Strong understanding of QMS, both methodologies and standards Strong understanding of FDA, EMA, and other ICH Health Authority requirements Understanding of industry quality management tools, quality systems (e.g. Veeva strongly preferred) Knowledge of quality principles and QA methodologies including GAMP5, 21 CFR Part 820, EudraLex Volume 4, ICH Chapters 7 through 11 and ISO 9001 8+ years relevant work experience in the pharmaceutical/biotech industry Experience with design and implementation of QMS business process and life cycle management Experience in supporting FDA inspections as a QMS subject matter expert and an ability to interpret regulatory requirements Experience in validation and configuration of systems to support business needs Experience authoring policies, procedures, and other technical documents for the Quality Management Systems processes Technical experience with data mining tools such as Power BI Demonstrated ability to work in a changing, cross-functional environment Detail oriented but also risk based Ability to handle diverse workloads, and capable of completing tasks with little or no supervision Strong communication skills and the ability to effectively collaborate with key stakeholders Strong project management and time management skills Compensation and Benefits
The base pay range is $190,000 - $200,000 annually; location, knowledge, skills and experience may affect pay. The total compensation package includes equity, bonus, and benefits. A summary of benefits is available for all applicants. Olema is an equal opportunity employer. We do not accept agency resumes. Important Information
Fraud Alert: Olema cautions about employment scams. Official Olema contact points end in @olema.com. Our official site is olema.com and our careers page is olema.com/careers. Communication from other sources may be fraudulent. Olema does not conduct interviews via text messaging and will not request payments or upfront fees. All interviews are conducted in person.
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Associate Director, Quality Systems role at Olema Oncology. Role supports the implementation, business requirements, and maintenance of the Veeva Quality suite of Computerized Systems and potentially AI initiatives. Develop, maintain and deliver training materials on such systems. Collaborate with other GXP functional departments (CMC, Clinical Operations, Supply Chain and Regulatory) to generate metrics and KPIs for continuous improvement and quality management review. This role may be based out of our San Francisco, CA or Cambridge, MA office and will require 20% travel. Responsibilities
Managing and upgrading the electronic quality management processes (eQMS) including modules for: document control, company training management, internal and external audits, vendor management, change control and deviation/CAPA management. Responsibility may additionally extend to Regulatory Information Management Systems (RIMS) and Inspection Management Systems to support Phase 3 clinical programs and transition to commercial manufacturing Serve as a Subject Matter Expert in Veeva Systems and Veeva Administrator to support business needs Liaising between QA, Operations (Regulatory, CMC, Non-Clinical, Drug Safety, Clinical) and IT to define, implement and manage eQMS systems; interactions for the training management will also include People & Culture, Facilities, Legal, and Finance Collaborating with IT and Operations for QMS process/system enhancements and process improvements Authoring, reviewing and, at times, approving policies, procedures, and other related documents for the Quality Management Systems processes at Olema Escalating Quality Management Systems-related issues to management for timely mitigation and resolution Supporting evolution of training materials and employee training execution for Quality Management Systems Supplying Quality Management System support during regulatory inspections with document retrieval functions, inspection logistics oversight and other support as needed Maintaining and managing audit (external and internal) documentation, while acting as a subject matter expert for electronic Quality Management Systems Creating and delivering QMS key performance and quality matrices to QA leadership and Executive management Communicating and promoting a culture of quality and operational excellence at Olema Qualifications
Bachelor’s degree in a scientific field is required; Master’s degree is preferred Strong understanding of QMS, both methodologies and standards Strong understanding of FDA, EMA, and other ICH Health Authority requirements Understanding of industry quality management tools, quality systems (e.g. Veeva strongly preferred) Knowledge of quality principles and QA methodologies including GAMP5, 21 CFR Part 820, EudraLex Volume 4, ICH Chapters 7 through 11 and ISO 9001 8+ years relevant work experience in the pharmaceutical/biotech industry Experience with design and implementation of QMS business process and life cycle management Experience in supporting FDA inspections as a QMS subject matter expert and an ability to interpret regulatory requirements Experience in validation and configuration of systems to support business needs Experience authoring policies, procedures, and other technical documents for the Quality Management Systems processes Technical experience with data mining tools such as Power BI Demonstrated ability to work in a changing, cross-functional environment Detail oriented but also risk based Ability to handle diverse workloads, and capable of completing tasks with little or no supervision Strong communication skills and the ability to effectively collaborate with key stakeholders Strong project management and time management skills Compensation and Benefits
The base pay range is $190,000 - $200,000 annually; location, knowledge, skills and experience may affect pay. The total compensation package includes equity, bonus, and benefits. A summary of benefits is available for all applicants. Olema is an equal opportunity employer. We do not accept agency resumes. Important Information
Fraud Alert: Olema cautions about employment scams. Official Olema contact points end in @olema.com. Our official site is olema.com and our careers page is olema.com/careers. Communication from other sources may be fraudulent. Olema does not conduct interviews via text messaging and will not request payments or upfront fees. All interviews are conducted in person.
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