MSD Associate Director Quality Assurance 

Ireland 

726277310

Job Description

A wonderful opportunity has arisen to join the Ballydine site as Associate Director Quality Assurance. Reporting to the Quality Director, the incumbent will work with the Quality Leadership team to ensure compliance with all regulatory requirements for Drug Substance (DS), Spray Dried Intermediate (SDI) and Drug product (DP) released to downstream customer. This is a permanent role with opportunities for some home working.

Role Responsibilities

• Provide Quality support to the Integrated Process Teams (IPT) to ensure the facility meets and operates to all Good Manufacturing Practice (GMP) requirements for development, clinical and commercial supply.
• Participate as a team member in the Documentation Review and Approval Process, Deviation Management Process, Quality Risk Management, Change Control Management and New Product Introduction.
• Support internal, customer and regulatory GMP audits of the plant. Act as lead auditor for internal walkdowns and systems audits to ensure compliance with cGMPs to maintain inspection readiness.
• Accountable for the development and performance of the team, providing input and coaching on professional development. Provide timely feedback and ensure that responsibilities are delivered following appropriate inclusion principles & behaviours.
• Lead and support Continuous Improvement of Quality and site processes.
  

Qualification Requirements

• Degree or post graduate qualification in Science, Pharmaceutical or Engineering field.
• Minimum of 5-year experience in the Pharma regulated industry with leadership experience. Clinical and commercial GMP experience preferred.
• Excellent knowledge of regulations and sources of regulatory information.
• Experience with regulatory inspections.
• Qualified Person qualification is an advantage.
• Experience in High Potency Manufacturing, Continuous Manufacturing, Spray Drying, Laboratory GMP and Project Management is desirable.
• Demonstrated continuous improvement mindset and capabilities.
• Dynamic individual with excellent organizational skills, who can effectively collaborate with cross functional teams.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,
please apply today.

Current Contingent Workers apply

Not Applicable