Senior Manager

Description:

Bristol Myers Squibb (BMS), a global leader in biopharmaceutical innovation, is seeking an experienced Senior Manager, Inspection Readiness to play a pivotal role in strengthening its inspection readiness program. Reporting to the Director of Inspection Readiness, this position is critical for ensuring enterprise-wide preparedness for global regulatory inspections and compliance audits.

The Senior Manager will act as a bridge between regulatory intelligence, quality systems, and operational readiness. Leveraging data analytics, risk modeling, and regulatory trend insights, this role ensures BMS is proactive in anticipating inspection requirements and continuously improving compliance systems.

Key Responsibilities include:

• Monitoring global regulatory inspection outcomes and enforcement actions to refine inspection readiness strategies.

• Benchmarking internal performance against industry standards and emerging regulatory expectations.

• Partnering with External Engagement teams to proactively address regulatory risks and implement predictive compliance strategies.

• Developing data-driven insights and actionable recommendations for readiness teams.

• Collaborating with Quality Risk Management to design risk models and identify high-risk processes/sites.

• Supporting inspection readiness activities such as pre-inspection audits, mock interviews, SME training, storyboards, and logistics.

• Delivering intelligence briefings and targeted preparation materials to stakeholders.

• Leading Global Regulatory Observation evaluations (GROe) to ensure timely assessments and mitigation of compliance risks.

• Driving process efficiency, simplification, and predictive analytics for continuous improvement.

Qualifications & Skills:

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

• Strong knowledge of global health authority regulations and pharmaceutical quality systems.

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

• Strong problem-solving, collaboration, and interpersonal skills with the ability to influence in a matrixed, global organization.

• Demonstrated ability to lead cross-functional initiatives across culturally and geographically diverse teams.

• Travel requirement up to 15% (with potential to exceed depending on business needs).

Benefits:
BMS provides a comprehensive benefits package including:

• Health, pharmacy, dental, and vision insurance

• Short-term & long-term disability insurance, life insurance, supplemental health coverage

• 401(k) with company contributions

• Paid vacation, sick leave, holidays, and global shutdown days

• Paid parental leave, caregiver leave, bereavement leave, and military leave

• Family care benefits such as adoption & surrogacy reimbursement, fertility support, elder & pet care resources

• Tuition reimbursement and employee recognition programs

• Opportunities for equity, stock, and incentive compensation

About the Company:
Bristol Myers Squibb is committed to transforming patients’ lives through science. The company thrives on innovation, urgency, accountability, and inclusion. At BMS, employees are empowered to drive change and contribute to cutting-edge solutions in cell therapy, drug development, and patient care. With global impact and a collaborative culture, working at BMS offers both professional growth and life-changing opportunities.