QA Manager, QA Analytics 80-100% (f/m/d)
Description du poste
Overview
In this role you will ensure QA Analytics aligns with GxP and regulatory requirements across QC processes. You will act as the interface between QC and QA Operations, collaborating with senior stakeholders across the site. You will review and approve critical QC/AD documents and records, investigate deviations, and drive CAPA and effectiveness checks to timely completion. You will represent QA Analytics as SME, guide cross-functional projects, and support regulatory inspections and audits.
Leistungen / Benefits- agile career and dynamic working culture
- inclusive and ethical workplace
- compensation programs recognizing high performance
- benefits depend on role and location
- Represent QA Analytics in cross-functional teams and meetings
- Advise on QA concerns to QC and ensure GxP requirements are met and SOPs followed
- Review and approve QC/AD related documents (e.g., method transfer, method validation, SOPs)
- Review and approve TW records related to QC processes
- Ensure QC deviations/investigations are properly investigated and documented per regulatory requirements
- Act as decision-maker during QC deviations/investigation process
- Drive QA Analytics and QC CAPA and Effectiveness checks to completion and timely closure
- Ensure documents are correct and adhere to SOPs and customer requirements
- Represent functional areas as QA Analytics SME and guide internal/external stakeholders
- Support and drive projects and revise/approve SOPs
- Support QC during regulatory inspections and customer audits
- Academic degree in Chemistry/Biochemistry/Biotechnology/Life Science or related field
- Extensive pharma industry experience in QC/QA
- Analytical expertise with method validation, change management, deviation management and investigations
- Strong background in cGMP, USP, European and Japanese Pharmacopeia
- Auditing experience and interaction with Health Authorities (FDA, Swissmedic)
- Experience in cross-functional teamwork
- Excellent English (verbal and written); German advantageous
- cross-functional collaboration
- clear communication
- problem solving
- analytical method validation
- change management
- deviation management
