You are here
Quality Director/Senior Manager
- Competitive salary package
- Highly visible senior leadership role in world-class manufacturing environment
About Our Client
Our client is the manufacturing arm of an established international medical device company practicing world-class manufacturing standards. This role is a replacement role and reports functionally to the Quality Site Lead and administratively to the Plant GM.
The Quality Director/Senior Manager will be expected to ensure the plant remains in full compliance with local/international regulatory requirements and ISO requirements as they pertain to the Group, customer specifications, and corporate quality policies.
- Implementation of document control and review/approval of controlled documents
- Implementation of change management and review of all change controls
- Implementation of supplier quality management and performance of supplier audits as appropriate
- Complaint management including robust root cause analysis and CAPA
- Implementation of an effective Internal Audit Program
- Ensure adequate Training Program is in place
- Implementation of applicable Validation Master Plans including equipment, process, product, sterilization and test methods
- Implementation of Quality Risk Management in relevant aspects of the QMS
The Successful Applicant
The ideal candidate for this position will have:
- At least a Bachelor's Degree in the Life Sciences, Masters or higher qualifications preferred.
- Minimum 10 years of experience in a regulated industry with preferred emphasis in the life sciences (e.g. pharma, biopharm, or medical device), with at least 4-5 years spent in a managerial capacity.
- Rich and in-depth experience in Quality System design, development, and implementation.
- Good multitasking abilities, strong communications, a collaborative spirit, and persistence in seeing things through to their end.
- Candidates who don't tick all the boxes but demonstrate tremendous potential and have had an excellent track record of being promoted ahead of time and a string of achievements are highly encouraged to explore.
What's on Offer
High visibility in an organization that prizes autonomy and new ideas, a very competitive salary package, a team of highly motivated staff, opportunities for overseas travel, regular learning/training opportunities.