Oxford Global is looking for a high qualified professional for a temporary role. This position will provide quality oversight, compliance remediation oversight and technical support for Reig Jofre - External Manufacturer (EM). Ensure the effective and compliant execution of quality processes and ensure the availability of a performant and compliant Quality System.
Responsibilities include but not limited to approval of Tech Transfer-related documents, review and approval of CAPA plans and monitoring their subsequent implementation, deviations, failure investigations, risk assessments. Review and approve EM quality system documents, specification and manufacturing instruction to ensure Janssen products/process comply to cGMP and regulatory requirements.
Provide QA support for technology transfer and improvement of existing manufacturing processes. Monitor quality performance of EM, proactive identification of risk and lead improvement program to mitigation EM risk. Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence (PEx, Lean etc.).
The incumbent will lead the External Quality team dedicated to the account, which includes Quality Persons-in-Plant and a team of Concurrent Verifiers to oversee the implementation and progress of the Site Operational and Quality Readiness Plan. The Quality Lead will coordinate and provide on-site leadership to the Stage Gate reviewers, who will perform Q&C Stage Gate audits on-site.
- Help Provide quality oversight to the EM
- Monitor trends, identify quality issues, recommend and implement appropriate actions.
- Ensure cGMP compliance by EM in quality investigation, deviation and CAPA management. Review and approve deviations and product disposition decision.
- Collaborate and support EM site during regulatory inspections. Monitor and follow up on regulatory commitments.
- Develop, implement, review and approve SOPs, specification, quality system documents.
- Investigate customer product quality complaints.
- Apply applicable cGMP regulations (EU, WHO) and other international requirements to all aspects of the position.
- Coordinate change control review and approval process.
- Lead EM risk management programs to obtain site qualification
- Provide Quality oversight and participate on technology transfer project teams
- Support Regulatory Submissions activities.
- Lead EM PAI readiness program in coordination with EM, Compliance, development team and project team.
- Maintain Quality Agreements and specifications changes
- Drive continuous improvements and engineer quality into the process
- Monitor trends, identify risk, troubleshoot, escalate to senior management as necessary.
- Lead Escalation as defined in SOP, provide quality leadership in issue management and risk mitigation plan
- Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc.) in the support of supply chain to meet patient supply requirements.
- Assess current quality systems, identify and implement improvements to enhance reliability and reduce cycle time.
Knowledge and skills
- MSc. Degree with a minimum of 8 years in an EU regulated environment is required in a pharmaceutical / biologics manufacturing or quality environment. Advanced degrees are a plus and may reduce the experience required.
- Demonstrates knowledge of Quality Assurance, Quality Control and Compliance. QA validation experience as well.
- Experience in the development, implementation and review of SOPs for interactions with contract manufacturers is preferred
- Contract role. Duration: 14-15 months.
- Very attractive salary according to the expertise and skills of the candidate.
- Location: Barcelona