Senior Manager, Quality Validation

W2 Contract

Pay Rate: $80 - $90 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

We are seeking a Senior Manager, Quality Validation who will play a key role within Quality Assurance, providing QA oversight and operational support across validation, GMP manufacturing, and quality systems. The initial focus of this role will be supporting transport and packaging validation activities to enable commercial readiness, while also providing support for broader QA initiatives as business needs evolve.

Duties and Responsibilities:

• Lead QA oversight of transport validation and primary/secondary packaging validation activities for drug product (DP) and finished packaged product (FPP) at CMOs, partnering with CMC, Supply Chain, Analytical Development, and other cross-functional teams to support commercial readiness.
• Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.
• Collaborate with internal and external stakeholders and execute quality systems as the QA SME on deviation investigations, CAPA plans, change controls, revisions to documentation, and other Quality processes.
• Establish and maintain internal quality metrics for the GMP Quality group that predict the performance and health of the quality systems and processes, and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.
• Provide Quality oversight as well as review and approval of CMO documentation (e.g., specification documents, Master Batch records, Executed Batch Records, Label Proofs, Validation Documentation, etc.)
• QA lead in periodically reviewing and revising GMP-related SOPs and procedures.
• Participate in inspection readiness efforts associated with commercial launch preparations.
• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Requirements and Qualifications:

• A Bachelor's degree in a scientific or technical discipline is required.
• A minimum of 8 years of experience in the pharmaceutical industry.
• Demonstrated experience providing QA oversight of transport validation and packaging process validation is strongly preferred. Experience supporting GMP manufacturing, process validation (PPQ), quality systems, and CMO oversight is also desirable.
• Experience managing quality aspects of validation, packaging, and testing activities at CMOs.
• Experience in process validation (PPQ) and commercial readiness.
• Experience in Inspection Readiness (domestic and ex-US).
• Knowledge of applicable US and Global compliance regulations and industry practices.
• Ability to critically evaluate and troubleshoot complex problems with diligence.
• Strong teamwork, collaboration, and management skills.
• Ability to manage multiple priorities and aggressive timelines.
• Highly responsible, self-motivated professional with enthusiasm and passion for the work.
• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. 

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