Manager / Sr. Manager, Quality Assurance (GxP)

Manager / Sr. Manager, Quality Assurance (GxP) Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. The Company’s mission is to develop medicines that matter.

Endeavor’s lead investigational candidates, ENV-101, is an inhibitor of the Hedgehog (Hh) signaling pathway in clinical development for the treatment of fibrotic lung disease, including idiopathic pulmonary fibrosis (IPF). The company’s second investigational candidate, ENV-501 is a human epidermal growth factor 3 (HER3)-targeted antibody-drug conjugate (ADC) for the treatment of HER3-positive solid tumors.

Endeavor BioMedicines is seeking a Manager/Sr. Manager 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.

Job Summary: Reporting to the Director of Quality Assurance, the manager will provide GCP/GMP leadership, including quality oversight and management of all GxP activities internally and externally with vendors. This will include, but not be limited to, inspection readiness and management, quality systems management, internal training program, internal audit program, and 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 workday.

Job Responsibilities :

Manage the QA oversight of global GMP contract development and manufacturing organizations (CDMOs), including review of analytical method validation documentation and raw data, stability protocols and reports, extension of retest and expiration dating, GMP drug substance (DS) and drug product (DP) specifications, GMP DS and DP master and executed batch records, and GMP DS and DP disposition and release. Assist in establishing, and ongoing management of, contract vendor relationships (e.g., CDMOs, Suppliers, Analytical Laboratories, Contract Research Organizations (CROs)), including review of Quality Technical/Development Agreements, Commercial Quality Agreements, attending Quality Meetings, and overseeing GxP quality issues. Conduct and oversee audits of GxP vendors, as required. Assist in the coordination and execution of the internal audit program. Assist in the design, preparation, and execution of inspection readiness activities, including active inspection support. Assist in the development, training, and execution of procedures supporting investigational clinical trial materials stock recovery and commercial product recall. 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) and administer the internal Change Control program and external Change Notification and Change Control program. Perform other duties as assigned by the Director, Quality Assurance.

Competencies:

Ability to form and maintain effective working relationships with internal and external business partners, stakeholders, and senior management. Effective decision-making abilities and problem-solving skills. Strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs. Ability to effectively multi-task and meet tight deadlines with high attention to detail. Thrive in a busy, fast-paced environment. Education and Qualifications :

Bachelor’s degree in a scientific discipline or equivalent experience. Master’s degree preferred. Seven years’ biotechnology and/or pharmaceutical 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.

Travel:

Up to 20%, both domestically and internationally.

The expected salary range for this position is $130,000 – $185,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. The total compensation package for this position also includes equity and bonus.

Endeavor BioMedicines provides a generous benefits package including medical, dental, vision, basic life, 401k, paid vacation, sick and holidays.

Endeavor BioMedicines is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, gender identity or expression, sexual orientation, national origin, disability, or veteran status.

*Agency Applications Will Not Be Considered. We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.