QA Sr. Manager - Inspection Readiness

Nature and Scope

The Senior Manager, Inspection Readiness is an enterprise governance role responsible for the design, implementation, and sustained oversight of a standardized inspection readiness program across all American Regent (ARI) sites and functions. This role serves as the Enterprise Inspection Readiness Leader, establishing strategy, governance, and operating models that ensure continuous regulatory preparedness across the organization. Operating without direct operational ownership, this role drives alignment, accountability, and maturity across sites and functions to embed inspection readiness into routine quality system execution.

Core Purpose

Design, lead, and sustain an enterprise inspection readiness program that ensures continuous regulatory readiness across all sites, functions, and GxP areas.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
• Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
• Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
• Define and maintain inspection readiness strategies aligned with global health authority expectations and ensure consistent inspection behaviors, messaging, and documentation practices across the organization.
• Design and govern enterprise mock inspection and inspection readiness audit programs that assess system maturity and regulatory mindset rather than checklist compliance, translating outcomes into prioritized enterprise actions.
• Establish enterprise methods for inspection risk identification and trending using deviations, investigations, CAPAs, audit outcomes, repeat observations, and quality system data.
• Provide governance oversight of post-inspection commitments, remediation plans, and CAPA execution to ensure timely, effective, and sustainable regulatory compliance.
• Define and govern inspection readiness KPIs, KRIs, leading indicators, dashboards, and reporting to provide executive visibility into inspection readiness posture, trends, and emerging risks.
• Design and deploy inspection readiness capability-building frameworks, standardized inspection roles, and training to drive a culture of continuous inspection readiness.
• Define governance and enterprise use cases for digital tools, AI, and inspection readiness platforms, including Microsoft Copilot and ACE software, ensuring data integrity, effective utilization, and regulatory compliance.
• Act as the enterprise business owner for inspection readiness technology solutions and partner with Quality, IT, Compliance, and other stakeholders to integrate digital capabilities into inspection readiness workflows.
• Serve as a senior advisory and escalation resource during regulatory inspections.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's degree in science, engineering, or related discipline required.

• 8+ years of experience in pharmaceutical or biotech quality, compliance, or regulatory functions, including progressive leadership roles required

• Demonstrated experience leading or supporting regulatory inspections and designing enterprise inspection readiness programs.
• Strong knowledge of global regulatory inspection expectations and quality systems, including deviations, investigations, CAPAs, audits, and systemic trending.
• Experience designing or implementing AI-enabled or data-driven tools for regulatory compliance or inspection gap analysis.
• Proven ability to influence across functions and organizational levels without direct authority.
• Strong analytical, problem-solving, and communication skills.
• Must have experience in designing and implementing AI tools for Heath Authority compliance gap analysis.
• Proven track record of leading people and teams to achieve organizational goals in support of strategic plans, and ability to extend influence beyond span of control.
• Direct experience leading or supporting regulatory inspections.
• Strong knowledge of global regulatory inspection frameworks and expectations.
• Demonstrated experience with deviations, investigations, CAPAs, audits, and quality systems.
• Extensive experience with deviation management, investigations, CAPA triage, effectiveness checks, and systemic trending.
• Demonstrated leadership in designing and governing inspection readiness programs.
• Proven ability to communicate at all levels of the organization and across functions to achieve desired results.
• Extensive experience developing inspection readiness frameworks, dashboards, or data-driven risk models.
• Problem solving and analytical skills: Incumbent must be able to think analytically and provide timely compliant resolution to all issues/challenges that may occur.

• Sustained inspection readiness independent of inspection timing.
• Reduction in repeat or systemic regulatory observations.
• Consistent inspection performance and effective post-inspection remediation.
• Clear executive visibility into enterprise inspection readiness and risk maturity.

Physical Environment and Requirements

• Remote role with up to 50% travel to all locations within the organization.
• Physical Participation in regulatory inspections and audits will be required.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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