We are seeking an Internal Operations Quality Partner to join a Clinical Supply Quality team.
As a team member, you will be responsible for, but not limited to, the QA review of IMP batch records, ensuring the prompt resolution of all batch manufacturing issues, and ensuring the close-out of development-related CAPAs.
This role provides direct, pragmatic, and proactive support for development manufacturing. You will be responsible for ensuring that appropriate quality systems are in place for the production, release, and distribution of IMP for Clinical trials.
In addition, you will be responsible for QA release support during regulatory inspections, active participation in the selection, evaluation, and approval of vendors, and quality improvement initiatives.
Major Responsibilities
Operational:
* Provide timely and efficient GMP/GDP IMP Release function for all relevant project activities related to pipeline development (including label approval, batch record documentation, etc.).
* Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP.
* Proactively support clinical supply activities for relevant manufacturing quality systems (deviation close-out / Change management / complaints / quality improvement).
* Provide support in the evaluation of Temperature excursions for IMP.
* Manage Quality Complaints of IMP.
* Oversee Distribution activities (deviations, assessments, etc.).
* Ensure adequate QA support for the qualification, validation, and maintenance of equipment, classified rooms, and HVAC used in development manufacturing areas.
* Contribute to the preparation for audits (internal/external, regulatory inspections).
* Lead internal audits / Self-Inspections.
Process:
* Ensure that all review and release, manufacturing, and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, etc. where relevant).
* * Support the Head of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections by government agencies.
* Actively participate in identifying, developing, and implementing local quality and operational excellence improvements.
* Review and provide QA approval of deviations, change controls, and complaints.
Education:
* Bachelor's Degree or Master's Degree is required.
Certification & Registration:
* Essential: Eligibility to act as a QP (Qualified Person) in the EU is essential.
* Essential: At least five years of practical experience in drug research and development or drug production quality management, including at least one year of drug quality management experience.
* Certification as an auditor by official authorities is an asset.
Competencies:
* Good knowledge of cGMP and relevant regulatory requirements (e.g., US, European, Japanese).
* QA/compliance experience in a pharmaceutical regulated environment.
* Ability to function effectively with minimal supervision.
* Good teamwork and project management skills; must have strong organization and analytical skills.
* Must be fluent in English; other languages are a bonus.
* A facilitator, influencer, and planner.
* Fact-based decision maker: able to understand complex issues and contribute to informed decision-making when working on "grey" issues.
* Experience participating in failure investigations.
* Familiarity with risk analysis techniques.