2 дня назад
Manager QA - Nights (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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