Senior Manager, Quality Operations (Remote) – Commercial Launch

Jobgether; EE. UU.; A distancia; USD 175.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual salary $175,000-$190,000 USD

Bonus eligibility (target)

Healthcare coverage

401(k) retirement plan

Life insurance

Paid time off

Remote work option

Travel up to 10%

Descripción de la vacante

Jobgether is seeking a Senior Manager, Quality Operations for a fully remote role in the United States to oversee quality activities across manufacturing and distribution for a smoking cessation product. You will lead batch review, release support, investigations, and risk management with CDMOs and 3PL partners, ensuring compliance and patient safety.

You will collaborate with Senior Director and suppliers to prepare for commercial launch, implement serialization, and ensure inspection

Formación

• Bachelor’s degree in life sciences or equivalent.
• 7+ years of GMP quality experience in pharma/biotech.
• Experience with batch records, release docs, and stability data.

Responsabilidades

• Review batch records, CoAs, CoCs, lab data, stability results, and release documentation; coordinate with CDMOs for disposition.
• Review deviations, investigations, CAPAs, and OOS events; assess risks and support root-cause analysis.
• Participate in complaint investigations and maintain documentation for commercial complaint management and patient safety.
• Collaborate with senior leaders and external vendors to implement processes for commercial launch, manufacturing, release, distribution, and post-approval requirements.
• Support DSCSA serialization and EPCIS data exchange; verify traceability data across supply chain.
• Coordinate with CDMOs and 3PL; monitor quality trends and conduct vendor qualification activities.
• Maintain inspection-ready documentation and contribute to Quality Operations metrics and annual product reviews.

Conocimientos

GMP knowledge

Quality assurance

CDMOs collaboration

Risk assessment

Documentation discipline

Communication

Educación

Bachelor's degree in life sciences

Herramientas

DSCSA serialization

EPCIS data exchange

Descripción del empleo

Jobgether is seeking a Senior Manager, Quality Operations for a fully remote role in the United States to oversee quality activities across manufacturing and distribution for a smoking cessation product. You will lead batch review, release support, investigations, and risk management with CDMOs and 3PL partners, ensuring compliance and patient safety.

You will collaborate with Senior Director and suppliers to prepare for commercial launch, implement serialization, and ensure inspection