Analytical Quality & Compliance Program Manager

View: 188

Update day: 24-04-2024

Location: Neuchâtel Neuchâtel NE

Category: Quality Assurance / Quality Control

Industry: Research Biotechnology Pharmaceuticals

Position: Mid-Senior level

Job type: Full-time

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Job content

Modis Life Sciences (The Adecco Group) is looking for one of it’s client a:

Your Responsibilities

Define/communicate and track all deliverables
Gather input from various sources : QMS integration team, site representatives optimization teams, leadership, and staff
Facilitate interactions/communication between process optimization teams to prevent silos, overlaps, gaps because different level 2s will be optimized at different times (risk-based) by different core teams
Provide feedback as needed
Communication plans, educate and engage stakeholders
Perform program and time management activities

Your Profile

BS/BA in a life science field
Minimum of 5 years professional experience in Quality Assurance, Quality Control, analytical chemistry, method development in the small molecules or biologics spaces
Previous experience in QC laboratory and in QA roles
Previous experience using electronic document and quality management systems (i.e., DCA, Veeva, PDLIMS, TrackWise)
Experience with QC testing procedures for small molecules and biologics
Experience in a GMP environment
Experience with the change control process, action plan evaluation, and coordination of change control progress within assigned areas of responsibility
Knowledge of QC, QA, analytical method development or method validation functions
Understanding and knowledge of FDA, ICH, and USP guidelines and GxP regulations
Excellent communication skills, attention to detail, relationship management skills, negotiation, problem-solving and personal time management skills
Ability to manage multiple priorities with aggressive timelines
Project/program management skills
Knowledge of quality management system
Experience with QMS integration is a plus
People change management skills: ability to influence and engage individuals and groups

#boost

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