North Eastern Services
Director, Quality Assurance (GxP)
North Eastern Services, San Diego, California, United States, 92189
Director, Quality Assurance (GxP)Endeavor BioMedicines is seeking a Director of Quality Assurance to join our growing team of passionate drug developers. We are a highly credentialed team whose collective expertise has driven industry-leading success. To build on this track record, we are looking for like-minded individuals who share our passion for restoring hope for patients with intractable diseases. Join us in our mission to transform science, re-think treatment expectations and positively impact patient lives. This will be a hybrid role, with an expectation of significant time spent on-site at our San Diego office.Reporting to the VP of Regulatory Affairs and Quality Assurance, the Director will lead the quality oversight and management of GxP activities internally and externally with vendors. This will include, but not be limited to, inspection readiness and management, quality systems management, external document review and approval, including batch disposition. The ideal candidate will have extensive quality assurance experience within the biotech and pharmaceutical sectors, will be a fast learner and self-motivator, have the ability to effectively multi-task to meet short deadlines, possess a high level of attention to detail, and can easily pivot throughout a work day. The ideal candidate should thrive in a busy, fast-paced environment.Job responsibilities:
Manage the QA oversight of GMP manufacturing vendors, including involvement and review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, GMP drug substance and drug product master and executed batch records, and GMP drug substance and drug product release.Assist in establishing, and ongoing management of, vendor relationships, including review of Quality Technical Agreements, attending Quality Meetings, and overseeing GxP quality issues.Conduct and oversee audits of GxP vendors, as required.Coordinate and execute the internal audit program.Assist in the design, preparation, and execution of inspection readiness activities, including active inspection support.Track and prepare GxP internal and external metric reports periodically, including annual review with the management team.Contribute to the management, maintenance, and evaluation of the Quality Management System and processes for optimization and continuous improvement.Ensure GxP compliance with regulatory requirements and internal procedures.Author and implement QA GxP standard operating procedures (SOPs).Perform other duties as assigned by the VP of Regulatory Affairs and Quality Assurance.Successful candidates will meet most of these criteria:
Bachelor’s degree in a scientific discipline or equivalent experience. Master’s degree preferred.Minimum of ten years industry experience in Quality Assurance (specifically GMP and GDP compliance; experience with GCP compliance is a plus).Thorough knowledge of applicable regulations (i.e., CFRs and ICH) to support product development in the US and ROW.A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.Ability to plan work and prioritize tasks to meet tight deadlines.Expected salary range:
The base pay range for this position is expected to be
$200,000 - $225,000
annually.Base pay offered may vary depending on job-related knowledge, skills, capabilities, and experience.The total compensation package for this position also includes equity, bonus, and benefits.
Endeavor BioMedicines is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.
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Manage the QA oversight of GMP manufacturing vendors, including involvement and review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, GMP drug substance and drug product master and executed batch records, and GMP drug substance and drug product release.Assist in establishing, and ongoing management of, vendor relationships, including review of Quality Technical Agreements, attending Quality Meetings, and overseeing GxP quality issues.Conduct and oversee audits of GxP vendors, as required.Coordinate and execute the internal audit program.Assist in the design, preparation, and execution of inspection readiness activities, including active inspection support.Track and prepare GxP internal and external metric reports periodically, including annual review with the management team.Contribute to the management, maintenance, and evaluation of the Quality Management System and processes for optimization and continuous improvement.Ensure GxP compliance with regulatory requirements and internal procedures.Author and implement QA GxP standard operating procedures (SOPs).Perform other duties as assigned by the VP of Regulatory Affairs and Quality Assurance.Successful candidates will meet most of these criteria:
Bachelor’s degree in a scientific discipline or equivalent experience. Master’s degree preferred.Minimum of ten years industry experience in Quality Assurance (specifically GMP and GDP compliance; experience with GCP compliance is a plus).Thorough knowledge of applicable regulations (i.e., CFRs and ICH) to support product development in the US and ROW.A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.Ability to plan work and prioritize tasks to meet tight deadlines.Expected salary range:
The base pay range for this position is expected to be
$200,000 - $225,000
annually.Base pay offered may vary depending on job-related knowledge, skills, capabilities, and experience.The total compensation package for this position also includes equity, bonus, and benefits.
Endeavor BioMedicines is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.
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