Manager, Supplier Quality

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Manager, Supplier Quality - This position can be based either in our San Diego, CA or Minnetonka, MN location.

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 a Manager, Supplier Quality, 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 Manager, Supplier Quality supports supplier evaluation, supplier performance monitoring, and supplier feedback to ensure that the Supplier Management Program is maintained in a state of compliance. They work in conjunction with other Halozyme internal teams on supplier selection, material/service qualification, procurement, and delivery, and are responsible for scheduling, leading and performing supplier audits, follow-up, and closure in accordance with current industry standards and Halozyme procedures.

In this role, you'll have the opportunity to:

• Ensure new suppliers are assessed, qualified, and approved in accordance with established procedures.

• Requalification of existing suppliers in accordance with established procedures.

• Write compliant audit reports of findings, observations and recommendations, track and trend supplier audit findings and/or associated CAPAs until closure, and complete supplier risk assessments.

• Ensure that supplier files are updated and maintained in accordance with established procedures, including the Approved Supplier List.

• Support the creation of and periodic updates to the annual supplier audit plan/schedule.

• Support supplier performance monitoring, including issuance of scorecards and identification of sub-par performance.

• Raise supplier/audit related critical issues to appropriate senior management in a timely manner.

• Manage Supplier Corrective Actions (SCAR) issued directly to suppliers, as assigned.

• Author/review supplier quality agreements.

• Lead the auditor qualification/training program, performing training of Halozyme auditors.

• Initiate new procedures and revise existing procedures for the supplier management program, as needed.

To succeed in this role, you'll need:

• Minimum of Bachelor's degree (scientific discipline preferred) with at least 8 years of GxP quality assurance experience in the pharmaceutical/biotechnology industry (an equivalent combination of education and experience may be considered).

• Medical device/combination product experience is a plus.

• Minimum of 5 years of auditing experience.

• Working knowledge of FDA and EMA regulations and thorough understanding of GMPs.

• Ability to act as the public face with suppliers.

• Industry-recognized certification or training as a Quality Lead Auditor highly desirable.

• Experience with eQMS (MasterControl preferred).

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 $105K - $147K 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.

AccessibilityandReasonableAccommodations:
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.