Olema Oncology
Senior Director, Quality Assurance
Olema Oncology, Boston, Massachusetts, us, 02298
Who We Are
Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.
Onto something big, together.
Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer.
Our
modern hybrid workplace model
encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams
build their
camaraderie , opening the door for more authentic mentorship and career development opportunities. While at home, employees can
make the most of their time
– whether that's picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees
the best of both work models .
About the Role >>> Senior Director, Quality Assurance
As the Senior Director of Quality Assurance, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will lead all quality activities supporting Olema's pipeline. You will oversee the development, implementation and maintenance of quality assurance systems and activities, and you will lead and build the quality team and function. You will be responsible for managing business relationships with defined stakeholder groups and leaders in the organization for the strategic development and delivery of risk-based quality management and vendor quality oversight.
This role is based out of our Cambridge or San Francisco office and will require 15% travel.
Your work will
primarily
encompass:
Contribution to the development of the GxP (GLP, GCP/GMP/GPV) Quality Management Systems, conduct risk assessments, develop and implement risk-mitigations and potential process improvements
Creation and implementation of a GxP inspection readiness strategy and plan in collaboration with leaders in the R&D organization
Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate
Oversee all audits and proactively prepare the organization for inspection readiness
Lead and manage all regulatory inspections in collaboration with internal and external partners
Ensure the company is compliant and in a constant state of inspection readiness across all GxP functions through continuous education, training, and internal audits
Implement and maintain quality metrics, systems and documentation associated with developmental activities of Olema's pipeline
Prepare the QA function to support registrational trials and ultimately commercial activities
Collaborate with R&D, product, manufacturing, clinical and regulatory teams, as well as external stakeholders to ensure quality standards are integrated throughout the product life cycle
Provide strategic and managerial leadership in all Quality related matters ensuring regulatory compliance of operational business matters
Successful quality oversight of Olema's Quality Management Systems, including Learning Management System and Regulatory Information Management System
And will also include:
Oversee the development of personnel within the quality department, building a strong team and clear vision to drive best in class performance
Maintain a pulse on the ever-changing quality assurance landscape and their implementation within Olema, monitor changes in regulations and keep project teams and management informed of such changes
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 is required, preferably in a scientific field; advanced degree is a plus
High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions
Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards
Strong knowledge of US, EU and other regulatory compliance/GxP requirements
Deep understanding of small molecule and oncology drug product development
Experience:
15+ years of drug development, including 10+ years of quality assurance experience in the Biotech/Pharmaceutical industry
Strong proven hands-on experiences with GLP, GCP, GPV and GMP compliance matters, and contractor management in the bio/pharma industry
Extensive experience handling regulatory inspections required
Previous experience with building and implementing QA systems (QMS, RIM, LMS, etc.)
Experience supporting products from early-stage development to post-approval
Experience leading BIMO and PAI inspections
Experience leading and developing team of individual contributors
Attributes:
Strong business acumen and ability to successfully work with international and cross functional partners
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
Excellent verbal, written and communication skills
Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders
Fosters open communication. Listens and facilitates discussion
Flexible, able to be successful in a past paced, lightly structured environment
The base pay range for this position is expected to be
$250,000 - $265,200
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.
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Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.
Onto something big, together.
Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer.
Our
modern hybrid workplace model
encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams
build their
camaraderie , opening the door for more authentic mentorship and career development opportunities. While at home, employees can
make the most of their time
– whether that's picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees
the best of both work models .
About the Role >>> Senior Director, Quality Assurance
As the Senior Director of Quality Assurance, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will lead all quality activities supporting Olema's pipeline. You will oversee the development, implementation and maintenance of quality assurance systems and activities, and you will lead and build the quality team and function. You will be responsible for managing business relationships with defined stakeholder groups and leaders in the organization for the strategic development and delivery of risk-based quality management and vendor quality oversight.
This role is based out of our Cambridge or San Francisco office and will require 15% travel.
Your work will
primarily
encompass:
Contribution to the development of the GxP (GLP, GCP/GMP/GPV) Quality Management Systems, conduct risk assessments, develop and implement risk-mitigations and potential process improvements
Creation and implementation of a GxP inspection readiness strategy and plan in collaboration with leaders in the R&D organization
Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate
Oversee all audits and proactively prepare the organization for inspection readiness
Lead and manage all regulatory inspections in collaboration with internal and external partners
Ensure the company is compliant and in a constant state of inspection readiness across all GxP functions through continuous education, training, and internal audits
Implement and maintain quality metrics, systems and documentation associated with developmental activities of Olema's pipeline
Prepare the QA function to support registrational trials and ultimately commercial activities
Collaborate with R&D, product, manufacturing, clinical and regulatory teams, as well as external stakeholders to ensure quality standards are integrated throughout the product life cycle
Provide strategic and managerial leadership in all Quality related matters ensuring regulatory compliance of operational business matters
Successful quality oversight of Olema's Quality Management Systems, including Learning Management System and Regulatory Information Management System
And will also include:
Oversee the development of personnel within the quality department, building a strong team and clear vision to drive best in class performance
Maintain a pulse on the ever-changing quality assurance landscape and their implementation within Olema, monitor changes in regulations and keep project teams and management informed of such changes
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 is required, preferably in a scientific field; advanced degree is a plus
High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions
Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards
Strong knowledge of US, EU and other regulatory compliance/GxP requirements
Deep understanding of small molecule and oncology drug product development
Experience:
15+ years of drug development, including 10+ years of quality assurance experience in the Biotech/Pharmaceutical industry
Strong proven hands-on experiences with GLP, GCP, GPV and GMP compliance matters, and contractor management in the bio/pharma industry
Extensive experience handling regulatory inspections required
Previous experience with building and implementing QA systems (QMS, RIM, LMS, etc.)
Experience supporting products from early-stage development to post-approval
Experience leading BIMO and PAI inspections
Experience leading and developing team of individual contributors
Attributes:
Strong business acumen and ability to successfully work with international and cross functional partners
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
Excellent verbal, written and communication skills
Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders
Fosters open communication. Listens and facilitates discussion
Flexible, able to be successful in a past paced, lightly structured environment
The base pay range for this position is expected to be
$250,000 - $265,200
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.
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