Quality Assurance Manager Role
This is a high-level position that oversees the QA review and approval process for various documentation, ensuring full compliance with GMP regulations.
Key Responsibilities:
* The Quality Assurance Manager will lead the review and approval of Change Controls, Deviations/CAPAs, SOPs, and related documents to guarantee adherence to GMP requirements.
* This role involves managing QA operational duties related to product disposition, ensuring timely and compliant decision-making.
* The incumbent will be responsible for monitoring and evaluating new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
* They will assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
* The Quality Assurance Manager will champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
* Participation in risk management activities is also required, applying relevant guidance and industry best practices to mitigate potential quality risks.
* This role supports and executes the internal audit program, including conducting audits as needed to ensure ongoing compliance and improvement.
Requirements:
* A degree in Science, Quality, or a related technical field is mandatory.
* The ideal candidate should have 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
* Strong written and verbal communication skills are essential, capable of clearly articulating complex quality issues.
* A logical thinker with the ability to remain proactive and composed under pressure is desired.
* Proven ability to work effectively both independently and collaboratively within a team is required.
* Exceptional attention to detail and precision in preparing and reviewing GMP documentation are necessary.
* Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms is an advantage.