Job Description
Senior Quality Manager
The Senior Quality Manager position is responsible to provide product quality stewardship of the products from introduction throughout the lifecycle. As the product quality expert, the Senior Quality Manager will build the strategy to proactively minimise product quality risks through early detection and mitigation during product development, technology transfer, commercial operations, and product discontinuation. The Senior Quality 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. Essential Functions 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.
Minimum Education, Experience, Skills BSc / 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 skills.
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: