Associate Director, External Quality Control

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Welcome to an inspired career.

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. Thats why we need youto 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 youll be part of a culture that welcomes diversity thinks differently to solve problems works collaboratively as one team and delivers meaningful innovations that impact peoples lives.

How you will make an impact

The Associate Director External Quality Control (QC) provides a full range of QC activities supporting Halozymes 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 Halozymes 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.

In this role youll have the opportunity to:

• 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 scaleup 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

To succeed in this role youll need:

• Minimum of a Bachelors 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)

In return we offer you:

• 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 impacton your career the work you do and patients lives.

The most likely base pay range for this position is $154K - $215K per year. Several factors such as experience tenure skills and particular business needs will determine an individuals exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses sales incentives and equity awards.

Halozyme Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race color religion sex sexual orientation gender identity national origin age protected veteran or disabled status or genetic information.

Accessibility and Reasonable Accommodations:

Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability contact Human Resources at .

To view all our open positions please visit our career page. Additionally our benefit offerings can be found here.