Associate Director, External Quality Control

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number. We look forward to discovering your talents. 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. 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. How you will make an impact 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. In this role, you’ll 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 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 To succeed in this role, you’ll need: 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) 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 impact—on 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 individual’s 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 hrbox@halozyme.com. To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here. Strength in diversity & collaboration Halozyme is a diverse team of innovators and problem solvers who bring their unique perspectives, backgrounds and individual life experiences to work every day. We are purposeful through our actions, working hard to cultivate a team that reflects our world and our values. Working together as one collaborative team, we can accomplish more than we ever could on our own. These ingredients are the best way to advance our mission. Equal Employment Opportunity Statement 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 (including traits historically associated with race, including but not limited to: hair texture and protective hair styles), religion, religious creed (including religious dress and grooming practices), ethnicity, color, national origin, ancestry, age (40 and older), genetic information, disability (mental and physical, including HIV and AIDS), reproductive health decision-making, medical leave or other types of protected leave, domestic violence victim status, political affiliation, medical condition (including cancer/ genetic characteristics and information), sex, gender, gender identity, gender expression, sexual orientation, marital or familial status, citizenship, pregnancy (including perceived pregnancy, childbirth, breastfeeding, or related medical conditions), military or veteran status, or any other status protected by federal, state, or local law. Click here to view the Know Your Rights Poster and the Pay Transparency Non-Discrimination Provision Poster. 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 an accommodation due to a disability, contact Human Resources at hrbox@halozyme.com. Notice to Agency Recruiters Halozyme does not accept unsolicited resumes from any agency that we have not directly engaged on a specific role. Our managers will not accept resumes sent directly from any agency/3rd party. Unsolicited resumes sent to Halozyme from recruiters do not constitute any type of relationship between the recruiter and Halozyme and do not obligate Halozyme to pay fees should we hire from those resumes. 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