What are the responsibilities and job description for the Associate Director, Quality Systems position at Olema Oncology?
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 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 is based out of our San Francisco, Ca or Cambridge, Ma office and will require 20% travel.
Your work will primarily encompass:
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:
Important Information >>>
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.
Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.
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 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 is 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.
- Liaising between QA, Operations (Regulatory, CMC, Non-clinical, Drug Safety & Clinical) and IT in defining, implementation and management of 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.
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, 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 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 and highly 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.
Important Information >>>
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.
Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.
Salary : $175,000 - $190,000
