QA Senior Manager

Job Overview:

Leads global process quality oversight activities by monitoring trending and evaluating escalations quality events audit/inspection outcomes and other quality signals to identify potential systemic process failures. Partners with functional and operational teams to define implement and verify effective corrective and preventive actions through end-to-end management of global process CAPAs supporting sustainable process improvement and inspection-ready quality governance.

Summary of Responsibilities:

Monitor review and trend escalations quality events audit and inspection findings process deviations and other quality signals to identify recurring themes emerging risks and potential systemic process failures.

Lead assessment of whether identified trends represent isolated issues functional gaps or broader global process weaknesses requiring formal remediation.

Partner with process owners operational leaders RCQA stakeholders and other cross-functional teams to define risk-based actions that address process gaps and prevent recurrence.

Own or support global process CAPAs from initiation through closure including problem statement development root cause evaluation action planning effectiveness measures evidence review and timely completion.

Ensure CAPA actions are appropriately scoped achievable inspection-defensible and aligned with applicable controlled documents regulatory expectations and business process ownership.

Maintain visibility of global process CAPA status risks dependencies and overdue or at-risk actions escalating appropriately to RCQA and functional leadership.

Develop and communicate quality insights trend summaries and process risk information to support management review governance forums and prioritization of process improvement activities.

Facilitate cross-functional discussions to align on process gaps ownership action plans implementation timelines and objective closure evidence.

Use data analysis and quality intelligence to recommend targeted process improvements that increase process effectiveness reduce repeat issues and strengthen quality oversight across RCQA and operational processes.

Act as a process quality partner to operations and enabling functions promoting a proactive culture of escalation issue management root cause thinking and sustainable corrective action.

Support preparation for audits inspections sponsor inquiries and internal governance discussions by ensuring process CAPA rationale evidence and effectiveness documentation are clear complete and defensible.

Contribute to global process governance forums by providing escalation trend analysis systemic issue insights CAPA progress updates and recommendations for prioritization.

Perform other duties as needed or assigned.

Qualifications (Minimum Required):

Bachelors degree in Life Sciences Quality Regulatory Affairs or related discipline preferred or equivalent relevant experience.

Experience may be substituted for education.

Experience (Minimum Required):

Typically 8 or more years of experience in regulated clinical research GxP quality assurance regulatory compliance process governance or related environment.

Demonstrated experience with quality systems CAPA management root cause analysis issue management escalation handling and/or process improvement in a regulated environment.

Strong understanding of applicable GxP regulations quality standards and expectations for inspection-ready documentation.

Ability to analyze quality data escalation trends and recurring issue patterns to identify potential systemic process failures and recommend appropriate remediation.

Proven ability to collaborate influence and negotiate with cross-functional stakeholders to achieve timely and sustainable process improvements.

Ability to distill complex quality information into clear conclusions risk-based recommendations and management-level communications.

Ability to lead or coordinate cross-functional teams through CAPA development implementation effectiveness verification and closure.

Experience preparing governance updates quality summaries or process risk communications for leadership forums preferred.

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