20 beste vacatures voor de functie van bestuursadviseur kwaliteit, veiligheid en in bloemendaal aan zee (nieuwe medewerkers gezocht)

Senior Director, Safety Operations
uniQure —Amsterdam
- Bachelor
- Managementervaring
3 dagen
Process Safety Excellence Manager
Henkel —Amsterdam
- Fulltime
- Hybride werken
- Engels
- Presentatievaardigheden
- Bachelor
- Werk vanuit huis
- Flexibele werkuren
Snel solliciteren
Safety Manager (m/f/d)
Flink —Amsterdam Centrum
- € 40.000 - € 55.000 per jaar
- Fulltime
- Engels
- ICT
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Snel solliciteren
Safety Consultant Environment
KLM —Schiphol
- € 5.300 - € 6.200 per maand
- Fulltime
- Engels
- Analytisch vermogen
- Bachelor
- Winstdeling
- Personeelskorting
23 uur
Safety & Pool Manager (m/v/x)
Center Parcs —Zandvoort
- Weekendbeschikbaarheid
- Analytisch vermogen
- Leidinggevende ervaring
- Gastenservice
- Reiskostenvergoeding
Snel solliciteren
9 dagen
Amsterdam - Instructor Offshore Safety
FMTC —Schiphol
- € 2.800 - € 4.000 per maand
- Engels
- ICT
HSE-Manager
P1 On- en Offstreet Management B.V. —Amsterdam
- € 4.600 - € 5.600 per maand
- Fulltime
- Hybride werken
- Management
- Kantoor
- Bachelor
- Tankpas
- Bedrijfsfitness
Snel solliciteren
Consultant Safety & Compliance
Qolor —Amsterdam
- € 4.000 - € 5.500 per maand
- Parttime
- Hybride werken
- Engineering
- Analytisch vermogen
- Bachelor
- Winstdeling
- Budget voor professionele ontwikkeling
Handhaver veiligheid openbaar vervoer
Gemeente Amsterdam —Amsterdam
- € 2.840 - € 4.015 per maand
- Weekendbeschikbaarheid
- Hybride werken
- Kantoor
- Reiskostenvergoeding
Senior HSE Consultant
Qolor —Amsterdam
- € 4.500 - € 6.000 per maand
- Parttime
- Hybride werken
- Analytisch vermogen
- Communicatieve vaardigheden
- Winstdeling
- Budget voor professionele ontwikkeling
Safety Manager
BUNGE —Amsterdam
- Analytisch vermogen
- Managementervaring
QA Specialist Food Safety
KLM Catering Services Schiphol B.V. —Schiphol
- € 4.298,77 - € 4.970,69 per maand
- Fulltime
- Hybride werken
- Engels
- Bachelor
- Reiskostenvergoeding
- Zorgverzekering
Snel solliciteren
2 dagen
BIM Coördinator brandveiligheid
Heijmans —Schiphol
- € 4.500 - € 6.000 per maand
- Parttime
- Hybride werken
- Analytisch vermogen
- Communicatieve vaardigheden
Zorgsupport Medewerker (Oproepkracht – Veiligheid) Loondienst
SURECARE B.V. —Amsterdam Centrum
- € 16,08 - € 19,98 per uur
- Fulltime
- Communicatieve vaardigheden
- Reiskostenvergoeding
Snel solliciteren
Ervaren consultant safety management
Qolor —Amsterdam
- Analytisch vermogen
Medewerker Receptie en Veiligheid
Arkin —Amsterdam
- € 2.735 - € 3.560 per maand
- Parttime
- Reiskostenvergoeding
- Flexibele werkuren
7 dagen
Medewerker Veiligheid en Service
BlueBridge Group —Amsterdam
- € 2.725,56 - € 3.831,84 per maand
- Weekendbeschikbaarheid
- Engels
Snel solliciteren
3 dagen
Project Leader - Audio Safety Schiphol
Bosch Group —Schiphol
- Hybride werken
- Projectmanagement
- Communicatieve vaardigheden
Snel solliciteren
Specialist Fire Safety Engineering
ABT —Amsterdam
- € 4.400 - € 6.583 per maand
- Parttime
- Engineering
- Bachelor
- Communicatieve vaardigheden
REOB Gecertificeerd Servicemonteur Brandveiligheid
Hoekstra opleidingen —Alkmaar
- E-mail

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Senior Director, Safety Operations

uniQure -
Amsterdam

Nu solliciteren

Vacaturegegevens

3 dagen geleden

Kwalificaties

Kwaliteitsborging
Bachelor
Risicomanagement
Klinische studies
Managementervaring

Volledige vacaturetekst

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

Patient Safety department ensures the safety of patients treated with uniQure products and guarantees uniQure meets all regulatory obligations with regards to pharmacovigilance (PV) requirements. The Senior Director Safety Operations is a key role in Patient Safety department, responsible for implementing the PV system, providing strategic direction and oversight of PV operations ensuring compliance with global PV regulations. This position represents the Patient Safety department internally and externally at a global level. He/She supports all PV operations including but not limited to vendor selection process, vendor management, inspection readiness, KPIs and CAPAs related to PV operations, case processing and periodic reporting metrics, SOP development and revision, and internal processes that support cross-functional PV initiatives.

Key result areas (major duties, accountabilities and responsibilities)

Design and implement fit-for-purpose post-marketing PV system at uniQure; oversight and maintenance of PV system validation; continuous optimization of the PV system, enabling efficiency increase through process innovation, automation and other technologies.
Lead effective vendor management strategies for PV, including budget oversight. Responsible for PV functional service provider strategy and managing the selection process. Responsible for developing a PV database strategy.
Serves as key point of contact between PV and the CROs regarding PV operation management. Communicates regularly with CROs and oversees ICSR case processing, periodic reporting (DSUR/PSUR) development, signal detection (including literature review) and other delegated tasks.
Accountable for the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs).
Provide PV Operational support to clinical trial study and commercial teams.
Accountable for risk management plan (RMP/REMS) strategy and implementation for uniQure products (both in development and marketed).
Support the EU QPPV. Oversee PSMF development/updates, implement relevant PV wording in uniQure contracts.
Ensure uniQure is inspection ready. In partnership with Quality, supports the escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions and the implementation of appropriate corrective actions, as needed.
Serve as a subject matter expert for internal audits and global regulatory inspections.
Develops PV training plans and competency assessments for Patient Safety department.
Responsible for Business Continuity management and oversight of the PV System, participate in BCP testing and assume BCP designated role as per crisis scenarios.
Implements new pharmacovigilance legislation into PV system, metrics, technical requirements & training.
Leads effective cross-functional collaboration with an emphasis on building business relationships with relevant uniQure stakeholders, including Clinical Development, Clinical Operations, Commercial, Medical Affairs, Quality, Biostatistics, IT, Legal, and Affiliates to establish and maintain an effective PV system.
Provides oversight and direction to direct report(s).

Qualifications & Skills

Bachelors degree in scientific related field preferred or combination education/experience.
10+ years of PV experience in the pharmaceutical industry with significant experience in biotech.
Clinical trial product support and commercial product support experience preferred.
Proven track record of leadership and operational excellence.
Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with other cross-functional groups.
Able to work independently, establish work priorities, and execute decisions with minimal guidance.
Able to influence across stakeholders and manage within a cross-functional matrix; seen as a collaborative partner within the organization.
Experienced in health authority inspections and/or internal or third-party audits.
Excellent knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA) and the affiliate environment, with a firm understanding of related quality assurance systems.
Experienced in developing training & quality documents (SOP / Guidelines / CAPAs).

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Verfijn je zoekopdracht

bestuursadviseur kwaliteit, veiligheid en vacatures in bloemendaal aan zee

Senior Director, Safety Operations

Process Safety Excellence Manager

Safety Manager (m/f/d)

Safety Consultant Environment

Safety & Pool Manager (m/v/x)

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HSE-Manager

Consultant Safety & Compliance

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Safety Manager

QA Specialist Food Safety

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Medewerker Receptie en Veiligheid

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Project Leader - Audio Safety Schiphol

Specialist Fire Safety Engineering

REOB Gecertificeerd Servicemonteur Brandveiligheid

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van bestuursadviseur kwaliteit, veiligheid en in bloemendaal aan zee

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