MSD Associate Director – QC Lab Operations 

Ireland, Cork 

810517416

Job Description

The Associate Director Operations Support, Laboratory Operations, reports to the Director Laboratory Operations and provides operations support to the Laboratory Operations of our organisation. Directs all aspects of the operations support activities within Laboratory Operations including stability program management, contract testing laboratory oversight, GMP compliance for vaccine drug substance and drug product testing including compendial compliance, change control, documentation control and inspection readiness. Ensures that products are tested in compliance with all regulatory guidelines and standard and facilitates innovation and continued improvement.

Primary Activities(Primary activities include, but are not limited to):

• Provides direction and leadership to the operations support team in the laboratories. Key activities include Stability program management, contract testing laboratory oversight and GMP compliance for vaccine drug substance and drug product testing.

• Ensures that the laboratories execute testing compliant with external regulatory guidelines, compendia, and internal GMP standards. This includes testing programs for raw materials, in-process materials, drug substance, and drug product.

• Ensures the operations support team have the resources needed to perform all activities required to maintain testing compliance.

• Assists Laboratory operations in resolution of any significant Quality Assurance and Quality Control activities, including deviations investigations.

• Ensures that Laboratory Operations are permanent inspection ready including ensuring all regulatory inspection observations are addressed in a complete and effective manner.

• Develops a strategic vision, managing headcount and profit plan.

• Ensures operations support team is compliant to safety policies and all operations are carried out in a safe manner.

• Works directly with Director Laboratory Operations on issues ranging from tactical/troubleshooting to strategic decisions.

• Serves on the Laboratory Operations management team. Provides consultation to the Director, Laboratory Operations, on general issues.

Activities Within Role: Primary Activities (Primary activities include, but are not limited to):

• Provides direction and leadership to the operations support team in the laboratories of the of our Vaccines Manufacturing Site. Key activities include Stability program management, contract testing laboratory oversight and GMP compliance for vaccine drug substance and drug product testing.

• Ensures that the laboratories execute testing compliant with external regulatory guidelines, compendia, and internal GMP standards. This includes testing programs for raw materials, in-process materials, drug substance, and drug product.

• Ensures the operations support team have the resources needed to perform all activities required to maintain testing compliance.

• Assists Laboratory operations in resolution of any significant Quality Assurance and Quality Control activities, including deviations investigations.

• Ensures that Laboratory Operations are permanent inspection ready including ensuring all regulatory inspection observations are addressed in a complete and effective manner.

• Develops a strategic vision, managing headcount and profit plan.

• Ensures operations support team is compliant to safety policies and all operations are carried out in a safe manner.

• Works directly with Director Laboratory Operations on issues ranging from tactical/troubleshooting to strategic decisions.

• Serves on the Laboratory Operations management team. Provides consultation to the Director, Laboratory Operations, on general issues.

Coaching and Training: Develop an effective team by understanding their abilities, unique contribution and broadening their skills to be agile and prepared for any future business requirements.

Reports to:Director, Laboratory Operations

Behaviours, Job Experience and Qualifications

Focus on what matters.

Act with urgency.

Experiment, learn and adapt.

Speak Up and be open-minded.

Job Experience: Required:

5 years of experience in quality and manufacturing operations. Experienced in vaccine or therapeutic protein manufacturing.

Experience in site-based quality and manufacturing operations managerial roles.

BSc in related field (Biology, Chemistry, Engineering). Advanced degree preferred.

Skill Set:

Incumbent must possess strong problem-solving skills, knowledge of GMPs and the ability to make decisions. Requires the ability to get things done through others.

Experienced in Lean/Six Sigma and Stability management.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our

So, if you are ready to:

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

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.