Senior Manager, Quality Assurance

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Manager, Quality Assurance based in the United States.

The Senior Manager, Quality Assurance will play a critical role in ensuring product quality, regulatory compliance, and commercial launch readiness within the pharmaceutical industry. This position focuses on quality oversight of transport validation and primary and secondary packaging validation for drug products and finished packaged products manufactured by contract manufacturing organizations (CMOs). You will collaborate with cross-functional teams to guide quality decisions and ensure alignment with global Good Manufacturing Practice (GMP) requirements. The role offers the opportunity to serve as a subject matter expert across deviations, corrective and preventive actions, change controls, and validation activities. You will also contribute to quality systems improvement, risk management, and the development of robust documentation and compliance practices. Working in a dynamic, deadline-driven environment, you will help strengthen inspection readiness and support the successful transition to commercial manufacturing. \n

Accountabilities

Lead quality assurance oversight of transport validation and primary and secondary packaging validation for drug products and finished packaged products at contract manufacturing organizations.

Represent Quality Assurance on cross-functional teams, providing guidance on quality, compliance, and regulatory expectations in line with current global regulations and industry standards.

Serve as a subject matter expert for deviations, corrective and preventive actions (CAPAs), change controls, and controlled documentation revisions.

Review and approve CMO documentation, including product specifications, master batch records, executed batch records, label proofs, and validation protocols and reports.

Oversee quality aspects of validation, packaging, and testing activities conducted at external manufacturing partners to ensure compliance and product quality.

Establish, monitor, and report quality performance metrics, emerging risks, and compliance challenges to senior management.

Periodically review, update, and improve Good Manufacturing Practice standard operating procedures (SOPs) and related quality procedures.

Support commercial launch preparation by maintaining inspection readiness and ensuring quality systems and documentation meet applicable regulatory requirements.

Collaborate with internal stakeholders and external partners to resolve quality issues, manage competing priorities, and maintain progress against critical project timelines.

Requirements:

Bachelor's degree in a scientific or technical discipline.

At least 8 years of experience in the pharmaceutical industry, with substantial experience in Quality Assurance.

Demonstrated experience overseeing transport validation and packaging process validation, strongly preferred.

Proven experience managing quality activities related to validation, packaging, and testing at contract manufacturing organizations.

Familiarity with process performance qualification (PPQ), commercial manufacturing readiness, and regulatory inspection preparation in the United States and internationally.

Strong knowledge of U.S. and global Good Manufacturing Practice (GMP) regulations, quality standards, and pharmaceutical industry practices.

Experience reviewing and approving manufacturing, packaging, labeling, and validation documentation.

Strong understanding of quality systems, including deviation management, CAPAs, change controls, and document control.

Excellent collaboration, communication, and stakeholder management skills, with the ability to influence cross-functional teams and external partners.

Strong organizational and prioritization skills, with the ability to manage multiple complex initiatives and deliver results under demanding timelines.

A proactive, detail-oriented approach to quality oversight, risk identification, regulatory compliance, and continuous improvement.

Benefits:

Work flexibility: Remote work opportunity within the United States.

Professional impact: The opportunity to support pharmaceutical commercial readiness and help maintain quality standards across external manufacturing operations.

Leadership opportunities: Collaboration with cross-functional teams and senior management on quality strategy, compliance risks, and operational readiness.

Technical development: Exposure to pharmaceutical validation, packaging operations, global GMP requirements, and inspection readiness activities.

Compensation and additional benefits: Salary, healthcare coverage, retirement plans, paid time off, and other benefits were not specified in the provided job description.

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