Sr. Spclst, Quality Systems

Job Description

An amazing opportunity has arisen as a Senior QA Specialist in the Centre of Excellence (COE) Quality Systems team, supporting activities in both the Drug Substance and Drug Product facilities on site.

The ideal candidate will have a strong background in quality validation, risk management, and internal auditing within a regulated environment. This senior role will champion QRM activities across site and will provide quality leadership during review of process and analytical validation documents.

The Senior Quality Specialist is a self-directed, decision maker who is responsible for the management and oversight of the Quality Management Systems in a diverse organisation that manufactures Drug Product, Drug Product Intermediate, and Drug Substance. The successful candidate will be responsible for ensuring the timely and effective completion of the Quality Systems core functions in accordance with site schedules and policies, procedures and guidelines. The successful candidate should demonstrate sound judgement to make good decisions based on information gathered and analysed.

What You Will Do

Bring energy, knowledge, innovation and leadership to carry out the following:

• Quality Risk Management Champion: Act as the Site Topic Lead (STL) for Quality Risk Management (QRM), facilitating quality risk assessment reviews, ensuring adherence to schedule for QRA completion and reviews and chairing site QRM committee meetings. The incumbent will promote a culture of risk awareness and permanent inspection readiness across site.
• Risk Register Maintenance: Initiate all QRM plans, ensuring the maintenance and accuracy of the risk register.
• Metrics: Participate in the generation and communication of quality metrics in relation to QRM.
• QA Validation Lead: Oversee the quality review of process and analytical validation documents, ensuring adherence to regulatory requirements and company standards.
• Validation Committee Chair: Schedule and lead validation committee meetings, define agendas, facilitate discussions on validation issues, and ensure timely action and documentation of meeting minutes.
• Support Validation Activities: Assist in the validation activities for Process Performance Qualification (PPQ) and commercial batches, ensuring the approval of all validation documentation and the development of validation summary reports.
• Lead Auditor: Conduct internal audits, clearly communicate audit findings, and work collaboratively to resolve identified issues.
• Regulatory Inspection Support: Provide front-facing support during regulatory inspections, acting as a subject matter expert for validation and QRM activities, and manage the backroom team during inspections.
• Change Control Assessment: Provide quality and change analyst review for all Change Requests (CRs) related to processes and analytical methods through all the stages of the CR process ensuring compliance with company and site policies, procedures and guidelines.
• Deviation Assessment: Analyse deviations to determine their impact on validation and ensure compliance with regulatory standards.
• Cross-Functional Project Management: Demonstrate capability in managing cross-functional projects, ensuring timely delivery and alignment with quality objectives.
• Continuous Process Improvement: Identify opportunities for process improvements and drive initiatives to enhance quality and efficiency across operations.
  
  

What Skills You Will Need

In order to excel in this role, you will more than likely have:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, LIMS, QSAT, Quality Docs).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Proven Leadership Skills
• Experience and knowledge of GMP Requirements for electronic/paper free operations.
• Experience in Drug Substance/Drug Product manufacturing / Spray drying / Validation / QRM / Project Management is desirable.
  
  

As a company, we are committed to 'Inventing for Life' in all that we do. 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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

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, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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

Regular

Relocation:

VISA Sponsorship

Travel Requirements:

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License:

Hazardous Material(s)

Required Skills:

Continual Improvement Process, Continual Improvement Process, Continuous Improvement Techniques, Critical Thinking, Customer-Focused, Customer Satisfaction, Detail-Oriented, GMP Compliance, Management Due Diligence, Management Process, Manufacturing Compliance, New Product Introduction Process, Pharmaceutical Manufacturing, Pharmacy, Process Qualification, Quality Improvement Programs, Quality Management Systems (QMS), Quality Metrics, Quality Process Development, Quality Risk Assessment, Quality Standards, Regulatory Compliance, Regulatory Inspections, Regulatory Requirements, Risk Management {+ 2 more}

Preferred Skills

Job Posting End Date:

05/31/2025

• 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.
  
  

Requisition ID:R350156
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