Manager, Supplier Quality

Antares Pharma • San Diego, CA

264d • $105,000 - $147,000

About The Position

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.

Requirements

• Minimum of Bachelor's degree (scientific discipline preferred) with at least 8 years of GxP quality assurance experience in the pharmaceutical/biotechnology industry.
• 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).

Nice To Haves

• Medical device/combination product experience is a plus.

Responsibilities

• Support supplier evaluation, supplier performance monitoring, and supplier feedback to ensure that the Supplier Management Program is maintained in a state of compliance.
• Work in conjunction with other Halozyme internal teams on supplier selection, material/service qualification, procurement, and delivery.
• Schedule, lead and perform supplier audits, follow-up, and closure in accordance with current industry standards and Halozyme procedures.
• Ensure new suppliers are assessed, qualified, and approved in accordance with established procedures.
• Requalify 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.

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: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree