Internal Operations Quality Partner 16531

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.