20 annunci per il ruolo di director of quality - switzerland (recruiting in corso)

Associate Director, Quality
Kiniksa Pharmaceuticals —Zugo, ZG
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Candidatura rapida
Senior Director, Global Quality Operations - Switzerland
Apellis Pharmaceuticals —Zugo, ZG
- 100%
- Gestionale
- Master
- Competenze analitiche
- Congedo parentale
Director, QMS BPO, Risk & Knowledge Management
BeiGene —Basilea, BS
- CHF 178’600 - CHF 223’300 all'anno
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
Global Patient Access Enablement, Reporting & Insights Lead, Associate Director
Takeda Pharmaceutical —Zurigo, ZH
- CHF 159’300 - CHF 219’010 all'anno
- 100%
- Gestionale
- Dottorato
- Project management
Plant Manager
Selegroven AG —Bironico, TI
- 100%
- Inglese
- Master
- Competenze analitiche
Candidatura rapida
5 giorni
Senior Director, Global Head of Client Services - Clinical Trials Division
Thermo Fisher Scientific —Basilea, BS
- CHF 157’700 - CHF 236’525 all'anno
- 100%
- Project management
- Bachelor
- Leadership
- Congedo parentale
Senior Director, Quality Operations EU
Integra LifeSciences —Le Locle, NE
- 100%
- Inglese
- Bachelor
- Produzione
Sr. Director, Commercial Quality / Market Quality
Scholar Rock —Zugo, ZG
- 100%
- Bachelor
- Leadership
- Capacità di comunicazione
Global Category Manager - CRO (Director)
Takeda Pharmaceutical —Zurigo, ZH
- CHF 177’400 - CHF 243’980 all'anno
- 100%
- Gestionale
- Master
- Competenze analitiche
Program Director - Genome of Switzerland (GoS)
emploi.epfl.ch —Losanna, VD
- Gestionale
- Dottorato
- Inglese
9 giorni
Quality and HSE Manager/Director
Pipecare Group —Zugo, ZG
- 100%
- Inglese
- Capacità di comunicazione
- Conoscenze di meccanica
Senior Project Director
MCI Group —Ginevra, GE
- Software CRM
- Esperienza settore turistico alberghiero
- Inglese
Director, Strategic Sourcing
Thermo Fisher Scientific —Allschwil, BL
- 100%
- Remoto
- Gestionale
- Inglese
- Competenze analitiche
Associate Director EU CTR Strategy & Operations Excellence Lead
Biogen —Baar, ZG
- 100%
- Project management
- Leadership
Senior Director, Head of Inspection & TMF Center of Excellence (all genders)
Merck KGaA —Eysins, VD
- Gestionale
- Dottorato
- Inglese
Capacity and Skills Development Officer
International Telecommunication Union (ITU) —Ginevra, GE
- Da CHF 71’335 all'anno
- Spagnolo
- Gestionale
- Dottorato
14 giorni
Executive Director, Regional Medical Lead - Solid Tumors, Medical Affairs, Europe
BeiGene —Basilea, BS
- CHF 263’700 - CHF 329’600 all'anno
- 100%
- Software CRM
- Disponibilità per trasferte fino al 50%
- Inglese
2 giorni
Sr. Manager, Quality Assurance
Acadia Pharmaceuticals Inc. —Zugo, ZG
- Inglese
- Master
- Bachelor
- Congedo parentale
9 giorni
Director of Sales (EU)
Doodle Labs —Home Office
- 100%
- Remoto
- Disponibilità per trasferte fino al 50%
- Vendite
- Forze armate
Candidatura rapida
(Senior) Bioanalytical Principal Investigator LBS / GLP Study Director (100%)
Celerion —Fehraltorf, ZH
- 100%
- Dottorato
- Inglese
- Competenze analitiche
Candidatura rapida

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Associate Director, Quality

Kiniksa Pharmaceuticals -
Zugo, ZG

Candidatura rapida

Dettagli della posizione

Qualifiche

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Outlook
Gestionale
Auditing
Microsoft Office
Bachelor
SharePoint
Produzione

Descrizione completa della posizione

The Associate Director, Quality is responsible for providing quality leadership and oversight for all GMP technical transfer activities, including process transfer from development to commercial manufacturing, site‑to‑site transfers, and CMO/CDMO technology transfers. This role ensures that transfers are executed in compliance with global regulatory requirements, company quality standards, and product lifecycle expectations.

The AD serves as the SME for tech transfer, partnering closely with Technical Operations, MS&T, Manufacturing, Supply Chain, Regulatory Affairs, and external partners.

Reporting to the Senior Director, Quality.

This role is based in our Zug, Switzerland or Lexington, Boston, USA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):

Provide Quality oversight and approval for all GMP technical transfer activities (clinical

commercial, site‑to‑site, CMO/CDMO) for both Drug Substance and Drug Product.
Ensure tech transfer strategies, protocols, reports, and control plans meet GMP, data integrity, and regulatory expectations.
Act as Quality lead on Tech Transfer Team and ensure timely escalation of quality risks.
Review and approve process descriptions, CPPs, CQAs, control strategies, and acceptance criteria during transfer.
Ensure appropriate comparability, validation, and verification strategies are defined and executed.
Confirm readiness for PPQ, conformance, and commercial launch from a Quality standpoint.
Approve tech transfer–related GMP documentation, including:
- Tech Transfer Protocols and Final Reports
- Process Validation documents
- Executed Batch Record
- Risk Assessments (FMEA, HACCP, etc.)
- Change Controls, Deviations, and CAPAs
Ensure transfers align with regulatory filings and submissions (IND, IMPD, NDA/BLA, MAA). Approve regulatory filing documentation supporting tech transfer.
Provide Quality oversight for CMO/CDMO tech transfers, including:
- Onboarding and qualification
- Audit support
- Quality Agreements and escalation pathways
Serve as the primary QA point of contact for GMP activities related to tech-transfer, scale-up, process validation/qualification and analytical method validation and transfer
Execute and support GMP quality Systems, including deviations, investigations, CAPA’s, change control, batch review, CPV, OOS/OOT management, and stability programs, ensuring timely and compliant closure
Participate in regulatory inspections and partner audits related to transferred products.
Develop and improve Quality Systems, SOPs, and internal guidelines.
Drive lessons learned, knowledge management, and lifecycle optimization.
Mentor Quality and cross‑functional team members on tech transfer best practices.
Host inspections from authorities and customer/partner audits
Embody Kiniksa’s cultural values and align actions with departmental goals and company culture

Qualifications:

10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality, or an equivalent combination of training and experience
Experience in DS and DP manufacturing, tech transfer
Bachelors or Advanced degree in a scientific discipline
Successful track record in managing external partners and batch certification to market
Understanding of worldwide requirements of cGMP and quality systems
In depth knowledge of EU Directives 2001/83/EU, 2001/20/EC, 2003/94/EC, ICH, global GMP/GDP standards, and Swiss MPLO 812.12.1
Experience in working with teams in other geographies
Experience interacting with regulatory health authorities at pre- and post-approval inspections
Established expertise and training in GxP systems
Strong team player that has a customer service approach and is solution-oriented
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Strong commitment to compliance and ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel up to 10%

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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director of quality offerte - switzerland

Associate Director, Quality

Senior Director, Global Quality Operations - Switzerland

Director, QMS BPO, Risk & Knowledge Management

Global Patient Access Enablement, Reporting & Insights Lead, Associate Director

Plant Manager

Senior Director, Global Head of Client Services - Clinical Trials Division

Senior Director, Quality Operations EU

Sr. Director, Commercial Quality / Market Quality

Global Category Manager - CRO (Director)

Program Director - Genome of Switzerland (GoS)

Quality and HSE Manager/Director

Senior Project Director

Director, Strategic Sourcing

Associate Director EU CTR Strategy & Operations Excellence Lead

Senior Director, Head of Inspection & TMF Center of Excellence (all genders)

Capacity and Skills Development Officer

Executive Director, Regional Medical Lead - Solid Tumors, Medical Affairs, Europe

Sr. Manager, Quality Assurance

Director of Sales (EU)

(Senior) Bioanalytical Principal Investigator LBS / GLP Study Director (100%)

Voglio ricevere gli ultimi avvisi Job Alert per il ruolo di director of quality nella seguente località: switzerland

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