Associate Director, External Quality Control (San José del …, San José del Rincón

How You Will Make An Impact Provide a full range of External Quality Control (QC) activities supporting Halozyme's ENHANZE programs across commercial, clinical, and development products and programs. Oversee Drug Substance (DS) and Drug Product (DP) Contract Manufacturing Organizations (CMOs) producing and testing Halozyme products, including supervision of staff. In This Role, You'll Have The Opportunity To Direct, lead, and develop a team of QC associates; mentor and provide growth opportunities. Direct and manage technical external QC activities during GMP analyses (e.g., technical data review for in-process, release, and stability; support method transfers, qualifications, validations, and QA technical interactions). Support CMOs with QC-related investigations and analytical method issues. Lead external QC activities, meet delivery dates, and lead technical areas across all programs while ensuring adherence to cGMP requirements at CMOs. Manage change controls for CMO analytical methods and laboratory impacting activities. Support QC/analytical aspects of new product scale-up, process improvement, technology transfer, and process-validation. Provide and manage required documentation: review/revision of procedures and specifications, annual product reviews, and support regulatory filing documents. Coordinate specification document updates for control system review and shelf life/retest updates. Communicate changes with partners; address partner regulatory information and program change requests. Author and/or review QC and analytical-related regulatory sections. Perform external audits/vendor qualifications (audit agendas and reports); support internal audits via audit readiness, responding to inquiries, and post-audit actions. Initiate QC-related CAPAs to maintain internal quality systems. Maintain awareness of analytical and regulatory developments. Develop/revise/implement/adhere to departmental policies and procedures affecting Quality. Contribute to the department budgeting process. To Succeed In This Role, You'll Need Bachelor's degree in a scientific subject area or engineering; 10 years proven experience (combination of education and experience may be considered). Strong background in analytical chemistry, microbiology, and biologics technologies; pharmaceutical QC experience. Demonstrated experience leading reference standard and stability programs. Expert writing and reviewing regulatory filings. Detailed understanding of GMPs, ICH guidelines, and regulatory guidelines. Ability to independently schedule, track, review, and report complex external QC activities. Ability to work closely with internal departments, partners, and CMOs (including senior management). Effective problem-solving and negotiation skills. Preferred Working knowledge and experience in QC assay development, qualification, and validation. Experience with external parties (CMOs, Contract Labs). Knowledge of statistical software (e.g., JMP) and QMS (e.g., MasterControl). In Return, We Offer You Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching. Opportunities to grow (learning/development, in-house programs, tuition reimbursement). #J-*****-Ljbffr Postúlate en Kit Empleo: kitempleo.com.mx/empleo/5v6xaf