Senior Manager

Description:

Bristol Myers Squibb, a global leader in biopharma, is seeking a Senior Manager, Inspection Readiness to join its Lawrence, NJ site. This role is pivotal in driving the company’s inspection readiness program across its GxP enterprise, ensuring continuous preparedness for evolving global regulatory requirements. Reporting to the Director, Inspection Readiness, the position leverages regulatory intelligence, data analytics, and risk management to proactively identify risks, inform strategic decisions, and strengthen compliance culture across the organization.

Key Responsibilities:

• Monitor and assess global regulatory inspection outcomes, enforcement trends, and emerging requirements to inform inspection readiness strategies.

• Benchmark internal performance against industry standards and regulatory expectations using external and Quality Risk Management (QRM) data.

• Adopt proactive and preventative readiness strategies by leveraging external intelligence and regulatory surveillance.

• Translate insights into actionable recommendations that support a predictive quality culture.

• Partner with QRM to build risk models identifying high-risk processes, areas, or sites.

• Collaborate with site Quality and Compliance teams to prioritize inspection readiness activities.

• Lead preparation, execution, and follow-up of inspection readiness initiatives, including pre-inspection audits, mock interviews, training, storyboard review, and logistics.

• Provide intelligence briefings, targeted SME preparation, and readiness training supported by data-driven insights.

• Drive communication and awareness of inspection risks and mitigation strategies through forums such as Quality Councils and Compliance Communities of Practice.

• Manage Global Regulatory Observation evaluations (GROe), ensuring proactive compliance and timely mitigation of risks.

• Develop and maintain Inspector Intelligence Reports and manage Regulatory Inspection Mailbox activities.

• Collaborate with Operations, Performance, and IT teams to introduce predictive risk analytics and improve readiness efficiencies.

Qualifications & Experience:

• Bachelor’s degree in Natural Sciences, Pharmacy, or related field (required).

• Minimum 5 years of experience in the pharmaceutical/biopharma sector, with strong knowledge of audits and inspections.

• Prior experience as an FDA Consumer Safety Officer (CSO) within the past 5 years highly preferred; at least 2 years as a CSO strongly desired.

• Strong understanding of global health authority regulations, quality systems, and pharmaceutical compliance requirements.

• Proficiency in regulatory intelligence tools, data visualization platforms, and analytics.

• Proven track record of collaboration within matrixed, global teams and ability to influence without direct authority.

• Excellent communication, problem-solving, and stakeholder management skills.

• Willingness to travel up to 15%, with flexibility for business needs.

Compensation & Benefits:

• Salary range: $139260 – $180569 annually ($11605 – $15047 monthly).

• Incentive cash and stock options may apply.

• Comprehensive benefits including medical, dental, vision, life, disability, 401(k) matching, tuition reimbursement, wellness programs, and generous paid time off (vacation, volunteer, caregiver, and parental leave).

• Employee-focused programs such as flexible schedules, summer hours, shutdown days, adoption/fertility benefits, child/elder/pet care resources, and global career growth opportunities.

About the Organization:
Bristol Myers Squibb (BMS) is committed to transforming patients’ lives through science. Operating in more than 25 global locations with 2000+ employees worldwide, BMS fosters a culture of innovation, inclusion, and integrity. Employees are empowered to drive meaningful impact in an environment that supports growth, collaboration, and cutting-edge medical breakthroughs.