Associate Director, External Quality Control

Halozyme • San Diego, CA

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About The Position

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive. Join us as an Associate Director, External Quality Control, and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives. The Associate Director, External Quality Control (QC) provides a full range of QC activities supporting Halozyme’s ENHANZE programs spanning commercial, clinical, and development products and programs in support of our partner relationships and internal programs. The position is pivotal to the execution of Halozyme’s product and program objectives, and requires individual, team and department work product contribution. This position has oversight of Drug Substance (DS) and Drug Product (DP) Contract Manufacturing Organizations (CMOs) producing and testing Halozyme products and includes the supervision of staff.

Requirements

• Minimum of a Bachelor’s degree in a scientific subject area or engineering, with 10 years proven experience (a combination of education and experience may be considered)
• Solid background in analytical chemistry, microbiology and technologies for Biologics and previous experience working in the pharmaceutical industry in QC
• Demonstrated experience leading reference standard and stability programs
• Expert writing and reviewing regulatory filings with a strong understanding of regulatory requirements
• Detailed understanding of GMPs, ICH guidelines, and regulatory guidelines
• Highly motivated and dedicated individual with the ability to work independently to schedule, track, review, and report on complex external QC activities per established guidelines and timelines
• Proven ability to work closely with internal departments, partners, and CMOs (including senior management) on significant matters concerning projects and commitments
• Effective problem solving and negotiation skills to meet business objectives in a highly dynamic global business environment
• Working knowledge and experience in QC assay development, qualification, and validation is desirable
• Experience working with external parties (CMOs, Contract Labs)
• Knowledge of software required: Statistical software (e.g. JMP) and QMS (e.g. MasterControl)

Responsibilities

• Direct, lead and develop a team of QC associates to accomplish Halozyme program requirements and mentor and provide growth opportunities to employees
• Direct, lead, and manage technical external QC activities (e.g., technical data review for in-process, release, and stability of DS and DP, support method transfers, qualifications, validations, QA technical interactions) during GMP analyses of DS/DP
• Work with appropriate subject matter experts to provide support to CMOs in QC-related investigations and analytical method issues
• Responsible for leading external QC activities, meeting delivery dates, and leading technical areas across all programs, ensuring appropriate adherence to cGMP requirements at CMOs
• Responsible for change controls for all CMO analytical methods and laboratory impacting activities
• Support QC/analytical aspects of new product scale–up, process improvement, technology transfer and process-validation activities
• Responsible for all activities related to providing required documentation, review and revision of procedures, specifications, annual product reviews, and supporting regulatory filing document
• Coordinate specification document updates for control system review and shelf life/retest updates
• Work with partners to communicate changes, address partner regulatory information and program change requests, resolving issues and requests
• Author and/or review QC and analytical-related regulatory sections to support all programs
• Perform external audits/vendor qualifications including generation of audit agendas and audit reports; support internal audits by participating in audit readiness activities, responding to auditor inquiries, and assisting post-audit actions
• Perform Quality activities associated with maintaining internal Quality Systems such as initiating QC-related CAPAs
• Maintain awareness of analytical and regulatory developments and directions
• Develop/revise/implement/adhere to departmental policies and procedures affecting Quality
• Contribute to department budgeting process

Benefits

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees