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: Director, Quality SystemsAs the Director, Quality Systems, reporting to the Senior Director of Quality Assurance, you will represent the QA in the implementation and maintenance of Computerized Systems as well as assessing new technologies, and their implementation to enhance regulatory compliance.
You will also develop and implement quality control policies, procedures and training materials that mitigate risk and promote a culture of quality assurance.
This role is based out of our San Francisco, CA or Cambridge, MA office and will require 20% travel.
Your work will primarily encompass:
Quality oversight for the Implementation and maintenance of computerized systems (eg., Quality Management System, Learning Management System, Regulatory Information Management System, electronic Trial Master File System etc.
).Establish and implement a Quality Governance structure, identification of risks and development of robust and timely risk mitigation strategies.Maintenance and administration of the Document Control and compliance system.Develop and implement quality control policies, procedures and training materials.Perform Audits per ISO Guidelines, and Regulatory Requirements.Analyze quality data and metrics to assess performance and compliance with standards.Perform and maintain corrective and preventive actions, audit/verifications, including customer and supplier.Support assessment and implementation of new technologies to enhance compliance and reduce cycle-times.Drive improvement of quality standards and contribute to development of new standards as needed to achieve regulatory compliance.Prepare and present quality reports to management and stakeholders on a monthly basis.Facilitate continuous improvement activities and share best practices across the organization.Ideal Candidate ProfileA 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.
KnowledgeBachelor's degree in a scientific field is required, Master's degree is preferred.Strong understanding of quality management systems, methodologies and standards.Strong understanding of FDA, EMA, and other ICH Health Authority requirements.In-depth understanding of industry quality management tools, quality systems (e.g., Veeva, Master Control, Qualio).Knowledge of Quality principles and QA methodologies including GAMP and ISO 9001.Experience12+ (BS) or 10+ (MS) years of experience working in clinical research, biotech, and/or pharmaceutical company, with 5+ years of specific experience working in quality systems.Experience with design and implementation of quality systems and life cycle management.Experience with establishing effective KPIs for quality systems.Experience in supporting FDA inspections as a quality system subject matter expert and an ability to interpret regulatory requirements.Excellent technical writing experience.AttributesDemonstrated ability to work in a highly cross-functional environment.Detail oriented and possess a professional demeanor, be adaptable to changing environments, 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 $220,000 - $230,000 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.
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.
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