QA Product Manager: Quality, Compliance & Audits Lead

Woodstock Sterile Solutions; Woodstock (IL); Presencial; USD 75.000 - 85.000; Jornada completa

Descripción de la vacante

Woodstock Sterile Solutions in Woodstock, IL, is seeking a QA Product Manager to coordinate QA operations for assigned products and customers. You will serve as the primary QA liaison, ensuring regulatory compliance and audit readiness across the site.

The role requires strong documentation, audit support, and collaboration with operations, customer service, and external partners. A Bachelor’s in a pharmaceutical-related field and 5+ years in pharma quality or regulated industry are expected.

Formación

• Five or more years of experience in pharmaceutical quality and/or regulatory functions.
• Experience working with third-party contract manufacturing in the pharmaceutical industry preferred.
• Ability to influence others and coordinate quality-system activities.

Responsabilidades

• Serve as the primary quality liaison for clients and internal customers and subject-matter expert for assigned products, processes, and requirements.
• Support New Product Development activities for products and processes without a designated QA Customer Service representative.
• Coordinate and/or lead regulatory audit backroom activities and support in-room audit activities as appropriate.
• Co-host and support client audits and conduct or support site internal audits.
• Maintain systems and procedures that monitor Quality System health and support audit readiness for client manufacturing areas.
• Perform statistical analyses and provide routine quality metrics to management.
• Develop and maintain client partnerships to ensure alignment, consensus, and effective issue resolution.

Conocimientos

Quality Assurance

Regulatory compliance

Auditing principles

Documentation practices

Communication skills

English proficiency

Educación

Bachelor’s degree in pharmaceutical-related field

Herramientas

MasterControl

Microsoft Word

Microsoft Excel

PowerPoint

Descripción del empleo

Woodstock Sterile Solutions in Woodstock, IL, is seeking a QA Product Manager to coordinate QA operations for assigned products and customers. You will serve as the primary QA liaison, ensuring regulatory compliance and audit readiness across the site.

The role requires strong documentation, audit support, and collaboration with operations, customer service, and external partners. A Bachelor’s in a pharmaceutical-related field and 5+ years in pharma quality or regulated industry are expected.