contractor quality lead

at  Digby Morgan

summary

• dublin, international
• contract
• specialismpharmaceutical
• sub specialismquality
• reference numberPR-1235316

job details
Our leading pharmaceutical client based in Dublin has an exciting opportunity for a Contractor Quality Lead to join their team.

Responsibilities:

• Understand supply chain for products from CMOs/suppliers, proactively identify quality/compliance risks.
• Manage quality audits, complaints, deviations and any other regulatory required information from the supplier.
• Assess the consequences of all noteworthy deviations originating from the contractor, escalate the issues, and take necessary actions as needed.
• Provide quality input to cross-functional teams internally and at the CMO.
• Lead investigations into significant quality concerns, ensuring timely and appropriate mitigation actions.
• Interact with middle management in GMS/Commercial Operations, negotiate and secure endorsement on quality decisions.
• Contribute to projects related to quality performance, systems, and continuous improvements.
• Participate in management escalation meetings, ensuring decisions are based on a scientific, fact-based approach.

Requirements:

• Bachelor’s degree in Science or equivalent.
• At least 4+ years of experience within the pharmaceutical industry
• Possess a strong knowledge of regulatory requirements.

Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
…
Our leading pharmaceutical client based in Dublin has an exciting opportunity for a Contractor Quality Lead to join their team.

Responsibilities:

• Understand supply chain for products from CMOs/suppliers, proactively identify quality/compliance risks.
• Manage quality audits, complaints, deviations and any other regulatory required information from the supplier.
• Assess the consequences of all noteworthy deviations originating from the contractor, escalate the issues, and take necessary actions as needed.
• Provide quality input to cross-functional teams internally and at the CMO.
• Lead investigations into significant quality concerns, ensuring timely and appropriate mitigation actions.
• Interact with middle management in GMS/Commercial Operations, negotiate and secure endorsement on quality decisions.
• Contribute to projects related to quality performance, systems, and continuous improvements.
• Participate in management escalation meetings, ensuring decisions are based on a scientific, fact-based approach.

Requirements:

• Bachelor’s degree in Science or equivalent.
• At least 4+ years of experience within the pharmaceutical industry
• Possess a strong knowledge of regulatory requirements.

Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 200

Responsibilities:

• Understand supply chain for products from CMOs/suppliers, proactively identify quality/compliance risks.
• Manage quality audits, complaints, deviations and any other regulatory required information from the supplier.
• Assess the consequences of all noteworthy deviations originating from the contractor, escalate the issues, and take necessary actions as needed.
• Provide quality input to cross-functional teams internally and at the CMO.
• Lead investigations into significant quality concerns, ensuring timely and appropriate mitigation actions.
• Interact with middle management in GMS/Commercial Operations, negotiate and secure endorsement on quality decisions.
• Contribute to projects related to quality performance, systems, and continuous improvements.
• Participate in management escalation meetings, ensuring decisions are based on a scientific, fact-based approach

Responsibilities:

• Understand supply chain for products from CMOs/suppliers, proactively identify quality/compliance risks.
• Manage quality audits, complaints, deviations and any other regulatory required information from the supplier.
• Assess the consequences of all noteworthy deviations originating from the contractor, escalate the issues, and take necessary actions as needed.
• Provide quality input to cross-functional teams internally and at the CMO.
• Lead investigations into significant quality concerns, ensuring timely and appropriate mitigation actions.
• Interact with middle management in GMS/Commercial Operations, negotiate and secure endorsement on quality decisions.
• Contribute to projects related to quality performance, systems, and continuous improvements.
• Participate in management escalation meetings, ensuring decisions are based on a scientific, fact-based approach