2 дня назад
Quality Control, Mgr
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control, Mgr (Microbiology and Analytical Chemistry): Leading microbiology and chemistry laboratory operations supporting product quality, patient safety, regulatory compliance, and batch disposition with an accent on cGMP testing, data integrity, contamination control, and inspection readiness. Focus on leading OOS and contamination investigations, managing CAPA and risk mitigation, and driving laboratory digitization, automation, and continuous improvement.
Location: São Paulo, Brazil
Company
is a healthcare company focused on developing and delivering products and solutions that support patient care and help save and sustain lives.
What you will do
- Lead daily operations of the Microbiology and Chemistry Laboratories, including testing execution, review, approval, staffing, workload prioritization, and capacity planning.
- Ensure laboratory activities support batch release, product disposition, manufacturing operations, regulatory commitments, and supply continuity.
- Provide technical leadership for cGMP laboratory controls, environmental and utility monitoring, contamination control, sterility assurance, analytical methods, instruments, and computerized laboratory systems.
- Lead investigations into OOS and OOT results, deviations, contamination events, environmental monitoring excursions, sterility failures, equipment failures, and data integrity concerns.
- Drive root cause analysis, quality risk assessments, CAPA development, effectiveness verification, inspection readiness, and regulatory audit support.
- Establish laboratory performance metrics and lead Lean Laboratory, automation, digitization, resource optimization, and technology investment initiatives.
Requirements
- Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or a related scientific discipline.
- 7–10 years of progressive experience in Quality Control, microbiology, analytical chemistry, pharmaceutical manufacturing, biotechnology, medical devices, healthcare manufacturing, or another regulated industry.
- 3–5 years of leadership experience managing laboratory operations, technical teams, or quality organizations.
- Advanced English level required.
- Experience with regulatory inspections, customer audits, compliance remediation, inspection readiness, microbiological and analytical investigations, contamination control, environmental monitoring, quality risk management, and CAPA systems.
- Strong background in cGMP laboratory operations, quality systems, method lifecycle management, equipment qualification, and data integrity requirements.
Nice to have
- Master’s degree or another advanced scientific qualification.
Culture & Benefits
- Work guided by the mission to save and sustain lives.
- Collaborative environment involving Quality Assurance, Manufacturing, Engineering, Validation, Technical Services, Regulatory Affairs, Supply Chain, and Global Quality.
- Focus on ownership, accountability, operational efficiency, continuous improvement, and meaningful impact.
- Equal employment opportunity and reasonable accommodation support are provided.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
5 дней назад
QC Supervisor (Microbiology)
5 дней назад
Senior Manager, QC Chemistry and Device Testing (CVRM)
120 100 - 223 100$
6 дней назад
Microbiologist (Biotechnology)
3 дня назад
Quality Control Supervisor-Analytical (Night Shift)
5 дней назад
Senior Manager, Microbiology (CVRM)
120 100 - 223 100$
6 дней назад