Associate Director - Quality Lead CQV/Shared Systems

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

Secondary Language(s) Job Description:

As a company, we are committed to 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.  

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.  

So, if you are ready to: 

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

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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 Preferred Skills:

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