Sr. Spclst, Quality Assurance (Upstream)

Merck; Ireland; On-site; EUR 80,000 - 110,000; Full time

Job summary

Merck in Ireland is seeking a Quality Assurance Senior Specialist (Upstream) to provide direct QA oversight of Upstream Drug Substance manufacturing and cell banking within a state-of-the-art facility in Dunboyne, Meath. You will lead QA activities, review CAPAs and change controls, and ensure cGMP compliance across processes.

The role requires a degree in Biochemistry/Biotechnology/Microbiology and 7–10 years in QA/QC or technical operations with upstream/cell banking oversight.

Qualifications

• Degree or postgraduate qualification in Biochemistry, Biotechnology, Microbiology, or related discipline.
• 7-10 years' experience in Quality Assurance, Quality Control or Technical Operations with direct oversight of Upstream processing and/or cell banking.
• Demonstrated knowledge of Master Cell Bank / Working Cell Bank management and Regulatory expectations, aseptic processing and GMP environments.
• Experience in QRM, Investigations, Deviations, and problem solving as a Quality SME.
• Strong written and verbal communication skills with ability to work under pressure.
• Team player with initiative and attention to GMP documentation.
• Experience interacting with regulatory agencies during site inspections.

Responsibilities

• Lead QA activities daily with cross-functional teams to address compliance issues.
• Participate in investigations related to deviations/complaints and ensure timely corrective actions.
• Review and approve Change Controls, Deviations/CAPAs, SOPs and related documentation.
• Perform QA operational Upstream and cell banking duties and related release activities to ensure on-time disposition.
• Evaluate new regulatory guidance and best practices and implement updates to Quality systems.
• Support risk management activities in line with guidance and industry practice.
• Provide QA oversight to qualification/validation, tech transfers, regulatory approvals and commercial/clinical operations.
• Mentor QA Operations Upstream team to foster a safe, compliant Quality & Safety culture and escalate risks when needed.

Skills

QA Leadership

Investigations

Deviations/CAPAs

SOP & Documentation

cGMP Compliance

Regulatory Inspections

Risk Management

Mentoring QA Ops Upstream

Education

Biochemistry / Biotechnology / Microbiology degree

Job description

Job Description

We have a wonderful opportunity for a Quality Assurance Senior Specialist (Upstream) our state-of-the-art, single-use, multi-product biotech facility in Dunboyne, County Meath, Ireland.

The Senior QA Specialist role (Upstream) will be part of the Quality Assurance Operations Self-Directed Work Team in a state-of-the-art single-use multi-product biotech facility in Dunboyne. The Senior QA Specialist role will provide direct QA oversight of Upstream Drug Substance manufacturing processes and cell banking activities, including Manufacturing of Master Cell Bank (MCB) and Working Cell Bank (WCB) and lifecycle management. The Senior Specialist will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations.

Key Accountabilities

• QA Leadership and participation daily with cross-functional teams to collaboratively and actively address compliance issues.
• Participate in investigations related to deviations/complaints, ensuring appropriate actions are implemented timely.
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation to ensure compliance with cGMP and facility requirements.
• Complete QA operational Upstream and Cell banking duties and related release activities to ensure on time disposition.
• Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
• Provide support for QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial and clinical operations.
• Work collaboratively to foster strong relationships with management and mentor QA Operations Upstream team to drive a safe and compliant driven Quality & Safety culture.
• Ensures the escalation of compliance risks to management in a timely manner.

Educational & Experience Requirements

• Degree or postgraduate qualification in Biochemistry, Biotechnology, Microbiology, or related discipline.
• 7-10 years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry with direct oversight of Upstream processing and/or cell banking.
• Demonstrated knowledge and experience of Master Cell Bank / Working Cell Bank management and Regulatory expectations, Aseptic processing and contamination control and GMP-compliant biologics manufacturing environments.
• Demonstrated experience in QRM, Investigations, Deviations, Problem solving as a Quality SME.
• Strong written and verbal communication skills with an ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Demonstrated knowledge and application of industrial regulations related to Biologics and/or Pharmaceuticals.
• Experience in direct interactions with regulatory agencies during site inspections.

Our facility in Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. Our Dunboyne facility provides Biologics Drug Substance manufacturing for Clinical Supply, Registration, and Commercial Launch.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology,

Required Skills

• Audit Readiness
• cGMP Regulations
• Compliance Activities
• Corrective Action Management
• Deviation Management
• Manufacturing Quality Control
• Pharmaceutical Quality Assurance
• Product Disposition
• Quality Assurance Processes
• Quality Management Standards
• Regulatory Compliance