Value Stream Quality Manager

🕒 il y a 2 mois

🏄 California – Distant

🏄 California – Remote

💵 $140 000 - $170 500 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

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ImmunityBio, Inc.

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501 - 1000 employés

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

Biotechnology • Healthcare Insurance • Pharmaceuticals

ImmunityBio, Inc. est une entreprise de biotechnologie axée sur le développement d'immunothérapies innovantes pour renforcer la capacité du système immunitaire à combattre le cancer et les maladies infectieuses. En exploitant la puissance de la réponse immunitaire de l'organisme, ImmunityBio vise à fournir des traitements révolutionnaires qui peuvent améliorer les résultats et la longévité des patients atteints de maladies difficiles.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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