10 часов назад
Senior Manager, Quality Asset Management (MedTech)
96 000 - 165 025€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Quality Asset Management (MedTech): Leading end-to-end quality strategy for Advanced Therapies products from early development through commercialization with an accent on CMC, value chain, regulatory submissions, and product lifecycle quality. Focus on coordinating global quality teams, managing quality risks and complaints, supporting inspections and audits, and making compliant decisions under uncertainty.
Location: Brussels, Belgium, or Little Island, Cork, Ireland; additional postings are available for the United States and Switzerland. The role requires flexible hours to support US, EMEA, and ASPAC schedules and up to 10% domestic and international travel.
Salary: €96,000–€165,025 annual base pay in the primary posting location and Belgium.
Company
Johnson & Johnson MedTech develops healthcare solutions and innovative medical technologies across the health spectrum.
What you will do
- Own the end-to-end quality strategy for Advanced Therapies products from early development through commercialization.
- Represent Global Quality on CMC and Value Chain Teams and act as the primary quality liaison for analytical and cross-functional groups.
- Ensure quality stage-gate deliverables, new product integration, lifecycle quality, and site quality activities are completed.
- Review and approve regulatory submissions and health authority responses, and support inspections, audits, field actions, and recalls.
- Lead quality subteams, coordinate external manufacturers and business partners, and resolve quality issues across sites.
- Drive risk-based decisions, control strategies, business continuity activities, complaint investigations, and escalation management.
Requirements
- Bachelor’s degree in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical or scientific discipline.
- At least 8 years of experience in the pharmaceutical or biotechnology industry.
- Knowledge of cGMP standards, policies, and procedures.
- Ability to influence, negotiate, present, partner across organizational boundaries, assess risks, and develop action plans.
- Ability to accommodate US, EMEA, and ASPAC working schedules and travel up to 10% domestically and internationally.
Nice to have
- Master’s degree or another advanced degree.
- Experience in biotech, vaccine, or sterile pharmaceutical manufacturing.
- Experience with technology transfer, process development, process validation, regulatory filings, inspections, API and drug product stability.
- Knowledge of change control, event handling, CAPA, risk management, manufacturing control strategies, QMS, GMP, ISO 9001, and quality auditing.
Culture & Benefits
- Inclusive work environment guided by the company’s Credo.
- Annual bonus based on pay grade, location, and performance.
- Vacation, parental, bereavement, caregiver, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Recognition awards and access to insurance plans subject to local eligibility and plan terms.
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