Olema Oncology
Associate Director, Quality Systems
Olema Oncology, San Francisco, California, United States, 94199
Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.
About the Role >>> Associate Director, Quality Systems As the Associate Director of Quality Systems, reporting to the Director of Quality Systems, you will support the implementation, business requirements, and maintenance of the Veeva Quality suite of Computerized Systems and potentially AI initiatives. You will also develop, maintain and deliver training materials on such systems. You will collaborate with other GXP functional departments (CMC, Clinical Operations, Supply Chain and Regulatory) to generate metrics and KPIs in order to facilitate 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.
Your work will primarily encompass:
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
Ideal Candidate Profile >>> A love of challenging, important work.
We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge :
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
Experience :
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
Attributes :
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
The base pay range for this position is expected to be
$190,000 - $200,000
annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-CK1
We provide
equal opportunity to all employees and applicants for employment
and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a
competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert
:
We are aware of employment scams where individuals pose as representatives of Olema Oncologyand make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com ; our careers page isolema.com/careers ; our LinkedIn page islinkedin.com/company/olema-oncology .Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.
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About the Role >>> Associate Director, Quality Systems As the Associate Director of Quality Systems, reporting to the Director of Quality Systems, you will support the implementation, business requirements, and maintenance of the Veeva Quality suite of Computerized Systems and potentially AI initiatives. You will also develop, maintain and deliver training materials on such systems. You will collaborate with other GXP functional departments (CMC, Clinical Operations, Supply Chain and Regulatory) to generate metrics and KPIs in order to facilitate 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.
Your work will primarily encompass:
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
Ideal Candidate Profile >>> A love of challenging, important work.
We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge :
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
Experience :
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
Attributes :
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
The base pay range for this position is expected to be
$190,000 - $200,000
annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-CK1
We provide
equal opportunity to all employees and applicants for employment
and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a
competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert
:
We are aware of employment scams where individuals pose as representatives of Olema Oncologyand make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com ; our careers page isolema.com/careers ; our LinkedIn page islinkedin.com/company/olema-oncology .Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.
Apply for this job *
indicates a required field
First Name *
Last Name *
Preferred First Name
Email *
Phone *
Resume/CV *
Enter manually
Accepted file types: pdf, doc, docx, txt, rtf
Enter manually
Accepted file types: pdf, doc, docx, txt, rtf
Home Address *
City *
State *
LinkedIn Profile *
Website
Are you legally authorized to work in the United States? * Select...
Do you now or will you in the future require employer sponsorship? * Select...
#J-18808-Ljbffr