Senior Quality Specialist

This Senior Specialist position is a critical role within the External Manufacturing Quality team, dedicated to ensuring that all Animal Health products supplied by North America-based Contract Manufacturers (CMOs) meet stringent company, regulatory, and customer quality standards. The incumbent will serve as the primary Quality Operations point of contact for these CMOs, directly overseeing their total quality performance and operations. The role is vital in ensuring that all batches are manufactured, packaged, analyzed, and released in complete conformance with the Product License, Product Quality Specifications, and Good Manufacturing Practices (GMP). This is a remote position based in the USA and reports to the Associate Director of External Manufacturing, requiring approximately 25% travel.
 

Responsibilities

• Acts as the Merck-AH Quality Operations point of contact and liaison between North America CMOs and internal company personnel.
• Assures that the CMO operates in strict compliance with all agreed-upon cGMP policies, procedures, and the Quality elements of the Commercial and Quality Agreements.
• Reviews and approves quality documentation, including validation/qualification protocols, transfer reports, and laboratory reports.
• Manages and handles quality incidents, including deviations, out-of-specifications, and non-conformities reported by CMOs, ensuring adherence to applicable Merck AH standards.
• Assures quality requirements on Change Proposals submitted by CMOs and/or Merck are met before approving the release of affected product batches.
• Ensures robust systems for supplier and CMO management oversight and assists the partner in preparing necessary Quality Systems and procedures.
• Enforces established validation requirements to ensure the manufacturing process is under control and in compliance with registered procedures.
• Contributes effectively to cross-functional investigation and project teams and handles product quality complaints according to company standards.

Education

• A Bachelor’s degree in science, Engineering, or an equivalent field is required.

Experience

• A minimum of 5 years of relevant professional experience is required.
• Must have expert knowledge of Quality Systems, Quality Assurance, and current GMP regulations (US and Global).
• Required experience with process and method transfers and a strong familiarity with sterility assurance / sterile processes.
• Must be familiar with process and laboratory methods validation and equipment qualification.
• Proven ability to apply sound risk management and excellent problem-solving skills based on science, facts, and data.

Additional Information

• The successful candidate must possess strong interpersonal communication, negotiation, and leadership skills to effectively manage non-routine and stressful situations with a variety of cultures.
• This role requires a highly organized individual with attention to detail and accuracy and the ability to exercise initiative and independent judgment while managing multiple priorities in a fast-paced environment.
• Excellent oral and written communication skills are essential.