Senior Upstream QA Specialist - Biologics

MSD; Dunboyne; Hybride; EUR 90 000 - 110 000; Plein temps

Résumé du poste

MSD in Dunboyne, Meath, Ireland seeks an experienced Quality Assurance Senior Specialist (Upstream) to provide QA oversight of upstream drug substance manufacturing and cell banking. You will lead investigations, CAPAs, and change controls, ensuring cGMP compliance and regulatory readiness across multiple product streams.

You will collaborate with cross-functional teams, mentor QA Operations Upstream, and stay aligned with evolving regulatory expectations to maintain the highest quality

Qualifications

• 7–10 years' experience in QA/Quality Control in biotech/pharma.
• Direct oversight of upstream processing and cell banking.
• Knowledge of Master Cell Bank/Working Cell Bank management and regulatory expectations.
• Experience with QRM, investigations, deviations, problem solving as a Quality SME.
• Strong written and verbal communication skills; able to work under pressure.
• Experience with interactions with regulatory agencies during site inspections.

Responsabilités

• Provide QA leadership with cross-functional teams to address compliance issues.
• Investigate deviations/complaints and ensure timely actions.
• Review/approve Change Controls, Deviations/CAPAs, SOPs for cGMP compliance.
• Complete QA operations for Upstream and cell banking duties and releases.
• Assess regulatory guidance and implement quality system updates.
• Support risk management activities aligned with guidance.
• Support QA oversight for qualification/validation, tech transfers, regulatory approvals.
• Mentor QA Operations Upstream team to drive a safe, compliant culture.
• Escalate compliance risks to management in a timely manner.

Connaissances

Audit readiness

cGMP regs

CAPA

Deviation mgmt

Manufacturing QC

Pharma QA

Product disposition

QA processes

Quality mgmt standards

Regulatory compliance

Compliance activities

Formation

Biochemistry/Biotech/Microbiology degree

Description du poste

MSD in Dunboyne, Meath, Ireland seeks an experienced Quality Assurance Senior Specialist (Upstream) to provide QA oversight of upstream drug substance manufacturing and cell banking. You will lead investigations, CAPAs, and change controls, ensuring cGMP compliance and regulatory readiness across multiple product streams.

You will collaborate with cross-functional teams, mentor QA Operations Upstream, and stay aligned with evolving regulatory expectations to maintain the highest quality