QA/Compliance Lead (m/f/d)

QA/Compliance Lead (m/f/d)- GxP / manufacturing / CSV / matrix leadership / project/change environment / ERP/ English and German

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified QA/Compliance Lead (m/f/d).

Background:
The local QA/Compliance Lead is primarily to ensure appropriate local Aspire activities and deliverables meet QA/Compliance expectations and ensure compliance is maintained. Ultimately, the local lead will be accountable for ensuring the site is „inspection ready“. The local Compliance Lead will work closely with core counterparts to understand the core deliverables and to ensure local compliance efforts are complementary to those produced on behalf of the wider programme. Locally, the Lead will ensure local change requests, protocols,CSV & quality deliverables, plans and reports are all completed in alignment with project plans/timelines and to ensure that any compliance risks are mitigated.

The perfect candidate has a successfully completed engineering degree in the field of biotechnology, pharmacology or process engineering combined with the necessary specialist knowledge for this activity. The person needs min. 5 years experience in a GMP regulated manufacturing environment and with validation responsibilities as well as min. 3 years of experience in quality management in the technical and CSV qualification fields. Experience in a matrix leadership role is required.

Tasks & Responsibilities:
* Accountable for local CSV & Quality deliverables defined for the local Deployment
* Definition of local Change Request/Validation/Implementation plans (incl. CSV) and related closure/reports
* Accountable for the local implementation plan, local implementation interim report, local implementation report according to CSV requirements and the respective SOPs
* Coordinate and support adoption of local SOPs triggered by ASPIRE (i.e. definition of the SOP inventory, planning of SOP updates and coordination of SOP updates according to plan)
* Supporting the training activities for ASPIRE
* Supporting test planning, execution, closure and defects
* Supporting data migration, esp., local verification and incidents associated with GxP data
* Supporting local cutover activities to ensure all protocols are completed and deviations accepted
* Supporting any definition of interim ways of working required during cutover
* Defining and supporting any PQ activities if required
* Compliance support for defects, incidents and change controls
* Coaching and training of local ASPIRE team as required in related compliance approaches/deliverables
* Accountability for compliance, quality assurance, deliverable acceptance, and sign-off processes within the ASPIRE project

Must Haves:
* Master Degree: With a successfully completed engineering degree in the field of biotechnology, pharmacology or process engineering, combined with the necessary specialist knowledge for this activity
* Min. 5 years experience in a GMP regulated manufacturing environment and with validation responsibilities
* Min. 3 years of experience in quality management in the technical and CSV qualification fields
* Extensive experience with the regulatory requirements in the GMP environment
* Experience in a matrix leadership role
* Compliance work within a project/change environment ideally experience in multi-site/global projects
* Understanding of ERP life cycle, deliverables and the compliance needs/implications
* Experience in previous deployment of global application to site is highly advantageous
* Fluent both in English and German (written/spoken)
* Excellent communication skills: The role requires clear direction locally, but also will involve global/above site engagement for both straightforward communication, and also influencing.
* Very Good x-functional understanding of compliance within a manufacturing site
* Ability to work in a matrix environment. Controlling/developing compliance deliverables and supporting other streams as appropriate
* Ability to understand the nature of risks and promote/support appropriate mitigations
* Coaching/supporting streams
* Ability to influence, esp. within a global team environment
* Ability to work within a multicultural environment

Reference Nr.: 922882SDA
Role: QA/Compliance Lead (m/f/d)
Industrie: Pharma
Workplace: Kaiseraugst and Basel
Pensum: 100%
Start: 01.10.2023
Duration: 21++
Deadline: 17.09.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.