
Manufacturing Director
1 day ago
At the heart of our organization, we are dedicated to delivering exceptional quality products that meet rigorous regulatory standards worldwide.
About This Role:- This is a leadership position where you will play a pivotal role in ensuring the quality and integrity of our manufacturing processes.
- Participate in evaluating external suppliers through due-diligence meetings, audits, etc., and provide input to senior management.
- Evaluate and ensure the availability of Quality Agreements with all Contract Manufacturing Organizations (CMOs) and service providers.
- Review existing Quality Agreements and amend them as needed.
- Evaluate compliance with our Quality Procedure and meet cGMP, regulatory, and legislative requirements.
- Plan and execute Quality Audits of CMOs and service providers according to the planned calendar.
- Coordinate with CMOs for change control, deviations, complaints, and Out-of-Specification issues.
- Evaluate CAPAs and ensure they are adequate and tracked until completion.
- Review Critical Quality Issues, recalls, counterfeits, and product tampering, according to the Quality Assurance Agreement and our Quality Procedure.
We Offer:
- A collaborative work environment
- Ongoing professional development opportunities
- An attractive compensation package
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