Value Stream Quality Manager

🕒 vor 1 Monat

🏄 California – Remote

🏄 California – Remote

💵 $140.000 - $170.500 / Jahr

⏰ Vollzeit

🟠 Senior

🔴 Experte

👔 Manager

Jetzt Bewerben

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ImmunityBio, Inc.

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

🧬 Biotechnologie

⚕️ Krankenversicherung

💊 Pharmazie

Biotechnology • Healthcare Insurance • Pharmaceuticals

ImmunityBio, Inc. ist ein Biotechnologieunternehmen, das sich auf die Entwicklung innovativer Immuntherapien konzentriert, um die Fähigkeit des Immunsystems zu verbessern, Krebs und Infektionskrankheiten zu bekämpfen. Durch die Nutzung der Kraft der Immunantwort des Körpers zielt ImmunityBio darauf ab, bahnbrechende Behandlungen bereitzustellen, die das Behandlungsergebnis und die Lebensdauer der Patienten bei herausfordernden Krankheiten verbessern können.

Beschreibung

• Oversight of the product lifecycle of ImmunityBio’s products from a quality perspective. • Work cross-functionally with Process Sciences, Manufacturing, Quality Control and Regulatory Affairs. • Support GMP production activities both internally at ImmunityBio and at external partners or CMOs for both clinical and commercial products. • Develop and implement quality control processes, analyze data to identify issues, collaborate with cross-functional teams, and drive continuous improvement initiatives. • Manage product lifecycle to ensure compliance with global GMP requirements for ImmunityBio products portfolio. • Own, lead and/or manage quality programs supporting Value Stream Quality activities and responsibilities. • Identify continuous improvement activities and implement changes to enhance the overall Value Stream Quality.

🎯 Anforderungen

• Bachelor’s degree in engineering, biological science, chemistry, or related science field is required. • 7+ years of experience in the clinical and/or commercial pharmaceutical / biopharmaceutical industry is required. • Minimum 5 years of direct experience in Quality Assurance / Quality Control is required. • Advanced understanding of and experience working with quality management systems and across all phases of the product lifecycle (early phase through commercial) is required. • Experience working with Contract Manufacturing Organizations (CMOs) is required. • Experience in supporting both internal and external regulatory inspections (e.g. FDA, EMA, MHRA) is preferred. • Lean, Six Sigma Greenbelt experience is required. Certification is preferred. • Knowledge of biologics cGMP manufacturing including recombinant protein and cell therapy cGMP manufacturing. • Strong knowledge of biologics cGMP aseptic manufacturing (required), including recombinant protein and cell therapy (preferred). • Must have strong authorship and be able to critically review batch production documents, interpret results, evaluate product impact, and generate technical conclusions consistent with Quality risk management principles. • Must be proficient in Microsoft Office (Excel, Word, Power Point, Visio) and Adobe Professional software.

🏖️ Vorteile

• Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day