Overview
Associate Director – Quality Lead CQV/Shared Systems Jobs in Dundalk, Maryland, USA at Merck Gruppe – MSD Sharp & Dohme
Job Description
As an Associate Director – Quality Lead CQV/Shared Systems, you will play a pivotal role in ensuring the highest standards of quality and compliance in our validation activities. This is an exciting opportunity to lead a dedicated team and contribute to the success of our cutting-edge projects.
Your Core Responsibilities
Lead and manage a team of QA Engineers, including contractors, to develop, support, and maintain Quality Assurance for Validations processes and systems.
Ensure validation and qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, CTUs, and shipping processes in compliance with cGMP, industry standards, and regulatory expectations.
Review and approve validation documentation and associated data for conformance to SOPs, specifications, and other applicable acceptance criteria.
Oversee and approve events/deviations, investigations, and change evaluations during qualification/validation activities, ensuring adherence to SOPs and cGMP requirements.
Implement, manage, and review SOPs related to QA Validation activities.
Provide support during regulatory inspections, offering QA Validations expertise to maintain facility validation status.
Coordinate QA Validations activities to ensure schedule adherence and timely delivery of project deliverables.
Oversee and approve events/deviations, investigations, and change evaluations for shared systems (e.g. engineering, utilities), ensuring adherence to SOPs and cGMP requirements.
Manage and develop the QA Validations team, including performance management, recruitment, and training.
Who You Are
You are ready if you have:
B.Sc or
B.Eng in a Scientific or Engineering discipline (e.g., biochemistry, chemistry, engineering).
Extensive experience in Quality Engineering/Quality Assurance/Quality Validations for Vaccine/Biologics or related pharmaceutical manufacturing in an FDA/EU regulated environment.
Proven experience in leading and developing teams.
Experience liaising with and responding to regulatory inspectors.
Thorough understanding of cGMP validation requirements for manufacturing facilities, including facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, CTUs, and shipping.
Strong technical aptitude and deep knowledge of GxP regulations and industry standards applicable to validation (e.g., EUGMP, FDA, ISO, GAMP, ISPE, ASME, BPE), along with troubleshooting and problem-solving skills, including formal root cause analysis methods and tools.
Experience with continuous improvement processes, demonstrating a proven ability to enhance operational efficiency and drive positive change.
Nice to have, but not essential:
Independent and self-motivated.
Able to multi-task in a fast-paced, dynamic working environment.
Green belt or Lean Six Sigma qualification.
Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status: Regular
Requisition : R344657
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Title: Associate Director – Quality Lead CQV/Shared Systems
Company: Merck Gruppe – MSD Sharp & Dohme
Location: Dundalk, Maryland, USA
Category: Quality Assurance – QA/QC (Data Analyst), Engineering
