20 annunci per il ruolo di director of quality - zürich, zh (recruiting in corso)

Associate Director, Quality
Kiniksa Pharmaceuticals —Zugo, ZG
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Candidatura rapida
Global Category Manager - CRO (Director)
Takeda Pharmaceutical —Zurigo, ZH
- CHF 177’400 - CHF 243’980 all'anno
- 100%
- Gestionale
- Master
- Competenze analitiche
Senior Director, Global Quality Operations - Switzerland
Apellis Pharmaceuticals —Zugo, ZG
- 100%
- Gestionale
- Master
- Competenze analitiche
- Congedo parentale
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
Business Process Excellence Director
Kanadevia Inova —Zurigo, ZH
- 100%
- Parzialmente remoto
- Inglese
- Master
- Bachelor
Candidatura rapida
1 giorno
Sr. Director, Commercial Quality / Market Quality
Scholar Rock —Zugo, ZG
- 100%
- Bachelor
- Leadership
- Capacità di comunicazione
Sr. Manager, Quality Assurance
Acadia Pharmaceuticals Inc. —Zugo, ZG
- Inglese
- Master
- Bachelor
- Congedo parentale
9 giorni
(Senior) Bioanalytical Principal Investigator LBS / GLP Study Director (100%)
Celerion —Fehraltorf, ZH
- 100%
- Dottorato
- Inglese
- Competenze analitiche
Candidatura rapida
Associate Director EU CTR Strategy & Operations Excellence Lead
Biogen —Baar, ZG
- 100%
- Project management
- Leadership
Quality and HSE Manager/Director
Pipecare Group —Zugo, ZG
- 100%
- Inglese
- Capacità di comunicazione
- Conoscenze di meccanica
Group Chief Operating Officer (COO)
Batgroup —Zurigo, ZH
- 100%
- Parzialmente remoto
- Inglese
- Pulizie
Candidatura rapida
Associate Director, Country Site & Operations FSP Oversight Manager
Biogen —Baar, ZG
- 100%
- Gestionale
- Project management
- Bachelor
6 giorni
Associate Director, Medical Grants and Sponsorship
Takeda Pharmaceutical —Zurigo, ZH
- CHF 169’400 - CHF 232’870 all'anno
- 100%
- Gestionale
- Dottorato
- Master
Head of Human Resources
International School of Zug and Luzern —Zugo, ZG
- 100%
- Gestionale
- Inglese
- Risorse umane
- Lavoro da casa
Candidatura rapida
(Sr.) Director of Value, Access and Policy, Europe
Acadia Pharmaceuticals Inc. —Zugo, ZG
- Microsoft Powerpoint
- Microsoft Excel
- Dottorato
- Congedo parentale
Executive Medical Director, Clinical Development Lead - Oncology - Lung & Head/Neck Cancers
GlaxoSmithKline —Baar, ZG
- CHF 242’250 - CHF 403’750 all'anno
- 100%
- Parzialmente remoto
- Dottorato
- In presenza
- Leadership
- Congedo parentale
Regulatory Strategy Associate Director
Vertex Pharmaceuticals —Zugo, ZG
- 100%
- Dottorato
- Inglese
- Master
Global Medical Lead, PDT Hematology (f/m/x)
Takeda Pharmaceutical —Zurigo, ZH
- CHF 189’400 - CHF 260’480 all'anno
- 100%
- Dottorato
Director, Performance Management and Capabilities Building (Academies)
Sonova —Stäfa, ZH
- Gestionale
- Inglese
- Master
Function Lead, International Regulatory (Exec Director/Sr. Director)
Denali Therapeutics —Zurigo, ZH
- Project management
- Bachelor
- Capacità di comunicazione
9 giorni

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

Accedendo al tuo account, accetti i Termini di Servizio di SimplyHired e acconsenti alle nostre Norme sui Cookie e sulla Privacy.

Esplora gli annunci in più località

director of quality jobs near zürich, zh

Annunci per il ruolo di Category Manager (Zürich, ZH)

Annunci per il ruolo di Shift Leader (Zürich, ZH)

Annunci per il ruolo di Head Of Human Resources (Zug, ZG)

Annunci per il ruolo di Director (Zürich, ZH)

Annunci per il ruolo di Associate Director (Zürich, ZH)

Annunci per il ruolo di Director Of Strategy (Zug, ZG)

Annunci per il ruolo di Quality Assurance Manager (Zug, ZG)

Annunci per il ruolo di Ristorante, Hotel, F&b Manager, Direttore (Kanton Tessin)

Annunci per il ruolo di Category Manager (Berne, BE)

Annunci per il ruolo di Category Manager (Geneva, GE)

Annunci per il ruolo di Supply Chain Manager (Zürich, ZH)

Annunci per il ruolo di Category Manager (Zug, ZG)

Annunci per il ruolo di Portfolio Manager (Zürich, ZH)

Annunci per il ruolo di Environmental Science (Zürich, ZH)

Annunci per il ruolo di Senior Operations Manager (Geneva, GE)

Annunci per il ruolo di Senior Business Development Manager (Zurigo, ZH)

Annunci per il ruolo di Bank Strategy (Zürich, ZH)

Annunci per il ruolo di Director Of Strategy (Zürich, ZH)

Annunci per il ruolo di Director Of Operations (Zug, ZG)

Annunci per il ruolo di Director Of Strategy (Basel, BS)

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.

Candidatura rapida

Perfeziona la tua ricerca

director of quality offerte - zürich, zh

Associate Director, Quality

Global Category Manager - CRO (Director)

Senior Director, Global Quality Operations - Switzerland

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

Business Process Excellence Director

Sr. Director, Commercial Quality / Market Quality

Sr. Manager, Quality Assurance

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

Associate Director EU CTR Strategy & Operations Excellence Lead

Quality and HSE Manager/Director

Group Chief Operating Officer (COO)

Associate Director, Country Site & Operations FSP Oversight Manager

Associate Director, Medical Grants and Sponsorship

Head of Human Resources

(Sr.) Director of Value, Access and Policy, Europe

Executive Medical Director, Clinical Development Lead - Oncology - Lung & Head/Neck Cancers

Regulatory Strategy Associate Director

Global Medical Lead, PDT Hematology (f/m/x)

Director, Performance Management and Capabilities Building (Academies)

Function Lead, International Regulatory (Exec Director/Sr. Director)

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

Related Searches

Esplora gli annunci in più località

Strumenti per chi cerca lavoro

Strumenti Aziende

Visualizza

Resta in contatto