Sr. Quality Manager

Contract Type: Permanent
Location: Dublin
Contact Name: Laurentina Kennedy
Contact Email:

Job Description

Senior Quality Manager
The Sr Manager position is responsible to provide product quality stewardship of the products from introduction throughout the lifecycle.
As the product quality expert, the Sr Manager will build the strategy to proactively minimize product quality risks through early detection and mitigation during product development, technology transfer, commercial operations, and product discontinuation.
Sr Manager is the Quality liaison between Regulatory Affairs and Operations (internal and/or contract manufacturer) to ensure regulatory compliance of manufacturing and testing processes (including contract labs). The role enables efficient communication and decision making related to the quality of our products.

Proactively manage product quality risks ensuring they are proactively mitigated, actioned, and escalated to senior management
Assess data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs
Act as Quality advocate and single point of contact for global program strategy teams to ensure consistent quality approach to GMP manufacturing, testing, release, and regulatory filings
Act as Quality expert for product quality history through lifecycle
Maintains Product Quality Monographs and Supply Chain Maps in compliance with investigational product and commercial marketing applications
Authors Global Annual Product Quality Review, coordinating with leads of contributing chapters, and manages commitments to closure
Provides lead quality review of CMC sections of Regulatory submissions and response to queries. Facilitates management and closure of post marketing regulatory commitments.
Lead Stability Review Boards to enable primary Quality oversight of the stability program including ensuring annual commitments are met
Primary Quality oversight of reference standard program with a focus on ensuring supply
Facilitates Product Specification Committee
Supports process lifecycle and analytical lifecycle management initiatives
Partner with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, BPDRs, recalls, etc
Facilitates global changes with respect to the product
Provides support where needed in the creation of Quality Target Product Profiles and product characterisation and comparability assessments in line with regulatory expectations
Supports Health Authority inspections and compliance

B.S / B.A. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.
8 years cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial
Previous experience working with FDA/ EU and participating in regulatory agency inspections preferred.
Candidate must exhibit strong interpersonal and collaborative / facilitative
Strong oral and written communication skills
Ability to work independently and in a team setting with minimal supervision
Ability to make sound decisions regarding compliance-related issues with minimal supervision
Strong Leadership, high level of personal/departmental accountability and responsibility

For further information on this Senior Quality Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Check out all our open jobs on our Recruitment website:
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