Senior Quality Manager
The Senior Quality Manager is responsible for providing product quality stewardship throughout the product lifecycle. As the product quality expert, the Senior Quality Manager builds strategies to proactively minimize product quality risks through early detection and mitigation during product development, technology transfer, commercial operations, and product discontinuation.
Key Responsibilities:
* Proactively manage product quality risks ensuring they are 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.
* 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.
Requirements:
* 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.