Associate Director, GCP Quality Assurance
Scorpion Therapeutics, San Francisco, CA, United States
About the Role
Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include 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 requires up to 20% travel. Your work will primarily encompass: Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines Provides GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), and communicates audit results to internal stakeholders Partners with QA leadership during regulatory authority inspections and drives GxP inspection readiness activities Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP Prepares for health authority inspections, suppliers and/or clinical sites Oversees clinical compliance and quality within the context of cross-functional study teams Continues to improve/refine Olema’s risk-based GCP compliance approach globally Manages Quality Management System (QMS) including, but not limited to, the following activities: QA review/approval of deviations, CAPAs and change controls Drafts, reviews, and approves policies, procedures, and work instructions Ideal Candidate Profile
Key Requirements We are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge: Bachelor’s Degree or higher in a scientific discipline Strong understanding of clinical trials and pharmacovigilance reporting In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) Experience: A minimum of 8 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 external, third-party vendors Hands-on experience with regulatory inspections and inspection readiness activities 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 Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines Attributes: Excellent verbal and written communication skills Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment 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 The base pay range for this position is expected to be
$190,000 - $210,000
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 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. Fraud Alert : We are aware of employment scams where individuals pose as representatives of Olema Oncology and 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 is olema.com/careers; our LinkedIn page is linkedin.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.
#J-18808-Ljbffr
Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include 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 requires up to 20% travel. Your work will primarily encompass: Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines Provides GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), and communicates audit results to internal stakeholders Partners with QA leadership during regulatory authority inspections and drives GxP inspection readiness activities Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP Prepares for health authority inspections, suppliers and/or clinical sites Oversees clinical compliance and quality within the context of cross-functional study teams Continues to improve/refine Olema’s risk-based GCP compliance approach globally Manages Quality Management System (QMS) including, but not limited to, the following activities: QA review/approval of deviations, CAPAs and change controls Drafts, reviews, and approves policies, procedures, and work instructions Ideal Candidate Profile
Key Requirements We are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge: Bachelor’s Degree or higher in a scientific discipline Strong understanding of clinical trials and pharmacovigilance reporting In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) Experience: A minimum of 8 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 external, third-party vendors Hands-on experience with regulatory inspections and inspection readiness activities 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 Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines Attributes: Excellent verbal and written communication skills Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment 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 The base pay range for this position is expected to be
$190,000 - $210,000
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 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. Fraud Alert : We are aware of employment scams where individuals pose as representatives of Olema Oncology and 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 is olema.com/careers; our LinkedIn page is linkedin.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.
#J-18808-Ljbffr