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5 дней назад

Quality Manager (Peptide API)

175 000 - 215 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Manager (Peptide API) (GMP/Pharmaceutical Manufacturing): Building and scaling an inspection-ready quality system for peptide API manufacturing, laboratory controls, and early-phase sterile product development with an accent on GMP compliance, validation, investigations, and data integrity. Focus on establishing quality processes, supporting facility and process qualification, leading inspection readiness, and making risk-based decisions in a startup-minded manufacturing environment.

Location: Menlo Park, California, United States; on-site

Salary: $175,000–$215,000 per year for US-based candidates, plus potential equity compensation.

Company

Hims & Hers is a public health and wellness platform delivering personalized access to diagnosis, treatment, and healthcare products.

What you will do

  • Build, implement, and oversee the site Quality Management System for peptide API manufacturing and development.
  • Establish document control, training, deviations, investigations, CAPA, change control, batch record review, and management review processes.
  • Provide quality oversight for raw materials, in-process controls, laboratory results, batch disposition, and release or rejection decisions.
  • Partner with Operations, Engineering, and Technical teams on facility scale-up, equipment qualification, process validation, method validation, and technology transfer.
  • Lead inspection readiness, audits, quality metrics, supplier qualification, and oversight of external laboratories and service providers.
  • Recruit, coach, and develop site Quality personnel.

Requirements

  • Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or a related field.
  • 8+ years of Quality experience in pharmaceutical, biotech, API, sterile manufacturing, or related GMP-regulated environments.
  • Strong knowledge of cGMP requirements, including 21 CFR 210/211, ICH Q7, data integrity, and risk-based Quality Systems.
  • Experience with qualification and validation, laboratory controls, investigations, inspection readiness, and cross-functional quality decisions.
  • Ability to spend meaningful time on-site in manufacturing, laboratory, and development areas.

Nice to have

  • Experience building or scaling Quality systems in an early-stage or rapidly evolving site.
  • Experience with peptide API manufacturing, complex chemical synthesis, sterile manufacturing support, or product development quality oversight.

Culture & Benefits

  • Fast-paced startup environment with evolving systems, priorities, and significant ownership.
  • Competitive salary, equity compensation, and Employee Stock Purchase Program.
  • Unlimited PTO, company holidays, and quarterly mental health days.
  • Medical, dental, vision, parental leave, and 401(k) with employer matching.
  • Offsite team retreats and flexibility to support startup, validation, and critical operational activities.

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