Senior Manager, Quality Assurance

Olema Oncology•Boston, MA

7d•Hybrid

About The Position

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond . You can view our latest corporate deck and other presentations here . As the Sr. Manager GCP Clinical Quality reporting to the Senior Director GCP Quality , you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety to actively participate in cross-functional study teams ensuring GCP/GVP compliance, assisting in identifying and communicating clinical trial-related risks and opportunities for process improvement as well as reviewing / approving study-related documents and plans and supporting audits. This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and will require up to 20% travel. Your work will primarily encompass: Assist in preparation for, and support of health authority inspections Supporting the training of cross-functional teams on inspection expectations and processes Verifying the completeness, accuracy, and availability of inspection-ready documentation Contributing to the development of inspection storyboards and key messaging Facilitating and participating in mock inspection activities Serving in front-room and back-room roles as required during inspections Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP Oversee clinical compliance and quality within the context of cross-functional study teams Continue to improve/refine Olema’s risk based GCP compliance approach globally Support Quality Management System (QMS) including, but not be limited to: QA review/approval of deviations, CAPAs and change controls Draft, review, and approve policies, procedures and work instructions Ideal Candidate Profile >>> Key Requirements 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.

Requirements

Bachelor’s degree is required, advanced degree (MS, PharmD, PhD) preferred
Strong understanding of clinical trials and pharmacovigilance reporting
Strong understanding of FDA, EMA, and ICH Health compliance requirements
Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.)
Minimum 7 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans
Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors
Experience preparing for and supporting regulatory agency inspections, primarily FDA; additional experience with other global regulatory agencies is an advantage
Experience writing and reviewing SOPs
Experience using QMS (Veeva systems preferred)
Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
Ability to work hands-on and be a strong individual contributor

Responsibilities

Assist in preparation for, and support of health authority inspections
Supporting the training of cross-functional teams on inspection expectations and processes
Verifying the completeness, accuracy, and availability of inspection-ready documentation
Contributing to the development of inspection storyboards and key messaging
Facilitating and participating in mock inspection activities
Serving in front-room and back-room roles as required during inspections
Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines
Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders
Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP
Oversee clinical compliance and quality within the context of cross-functional study teams
Continue to improve/refine Olema’s risk based GCP compliance approach globally
Support Quality Management System (QMS) including, but not be limited to: QA review/approval of deviations, CAPAs and change controls
Draft, review, and approve policies, procedures and work instructions