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2 дня назад

Manager QA - Nights (Biotech)

Формат работы
onsite
Тип работы
fulltime
Грейд
lead
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
Manager QA - Nights (Biotech): Leading nighttime Quality Assurance operations for GMP manufacturing, including personnel management, procedure approval, investigations, validation, and change control with an accent on compliant manufacturing and risk-based decision-making. Focus on overseeing the M–F 6:00 PM–2:30 AM shift, resolving manufacturing issues, leading audits, and driving improvements across QA performance.

Location: West Greenwich, Rhode Island, United States; onsite night shift, Monday–Friday, 6:00 PM–2:30 AM

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

  • Hire, train, develop, and manage Quality Assurance professionals supporting GMP manufacturing.
  • Oversee the night-shift QA team and independently manage daily operations within established policies.
  • Develop and communicate goals, standards, procedures, and improvement priorities for the team.
  • Represent QA in incident triage, project teams, investigations, audits, and manufacturing issue resolution.
  • Review and approve operating procedures, manufacturing procedures, validation protocols and reports, environmental characterization reports, and change-control documents.
  • Approve non-conformances and changeover controls while driving compliant change and operational excellence.

Requirements

  • High school diploma/GED with 12 years of Quality or Manufacturing experience; associate degree with 10 years; bachelor’s degree with 5 years; master’s degree with 3 years; or doctorate degree.
  • Direct people-management or demonstrated leadership experience managing teams, projects, programs, or resource allocation.
  • Experience in biotechnology or pharmaceutical quality assurance and/or manufacturing, including investigations, CAPA, product release, validation, or change control.
  • Knowledge of regulations, standards, and guidelines applicable to biotech manufacturing in a multi-product environment.
  • Ability to develop staff goals, manage performance, coach employees, communicate clearly, facilitate discussions, and influence compliant practices.
  • Ability to make independent, risk-based decisions on the manufacturing floor and manage established timelines.

Nice to have

  • Bachelor’s degree in Life Sciences, Engineering, or a related field.
  • Six or more years of quality assurance or combined quality and manufacturing experience in biotechnology or pharmaceuticals.
  • Two or more years of supervisory or management experience.
  • Thorough knowledge of monoclonal antibody manufacturing or equivalent biotech manufacturing knowledge.

Culture & Benefits

  • Collaborative, innovative, science-based work environment.
  • Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
  • Retirement and savings plan with company contributions.
  • Annual discretionary bonus program and stock-based long-term incentives.
  • Paid time-off plans and career development opportunities.
  • Sponsorship for this role is not guaranteed.

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