Senior Business Development Manager
FUJIFILM Corporation
Senior Manager, Inspection Readiness
Bristol Myers Squibb
full-time
Posted on:
Location Type: Office
Location: Princeton • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $149,010 - $180,569 per year
Job Level
Senior
About the role
- Reporting to the Director, Inspection Readiness and advancing the organization’s inspection readiness program.
- Leverage data analytics, regulatory trends, and quality insights to proactively identify and mitigate risks and inform strategic decision-making.
- Serve as a link between regulatory intelligence, quality systems, and operational readiness to ensure preparedness for global regulatory expectations.
- Monitor and assess global regulatory inspection outcomes, enforcement actions, and emerging trends to inform inspection readiness strategies.
- Benchmark internal performance against industry standards and regulatory expectations using internal, external, and QRM data.
- Adopt a proactive and preventative approach to inspection readiness through surveillance of regulatory changes and inspection activity.
- Translate insights into actionable recommendations and support transition to a predictive quality organization.
- Develop risk models in collaboration with Quality Risk Management to identify high-risk areas, processes, or sites.
- Collaborate with site Quality and Compliance teams to prioritize readiness activities and support preparation, execution, and follow-up of inspection readiness activities.
- Disseminate timely alerts and updates, provide intelligence briefings and targeted preparation materials for SMEs, and support mock inspections and readiness training with data-driven insights.
- Lead Global Regulatory Observation evaluations (GROe) and seek opportunities for simplification and efficiency across the GROe process.
- Provide Inspector Intelligence Reports and monitor the Regulatory Inspection Mailbox.
- Develop and maintain partnerships with Operations & Performance and BIT teams to implement automated predictive risk opportunities.
Requirements
- A minimum of five (5) years’ experience in the Biopharm/Pharmaceutical industry with knowledge of audits and inspections.
- Bachelor’s degree in Natural Science, Pharmacy, or related fields, required.
- Candidate will have previously conducted inspections in pharmaceutical (medical device, biologics) facilities.
- Preferably worked for the US Food & Drug Administration (FDA) within the past 5 years (2015-2025) in a Consumer Safety Officer (CSO) or similar role; minimum of 2 years’ experience as a CSO preferred.
- Proven ability to understand complex processes/problems and propose alternate solutions.
- Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
- Strong communication, collaboration, negotiation, problem solving and interpersonal skills.
- Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control.
- Proven track record of working across the network to find common solutions and drive positive impact and benefits for patients.
- Strong knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
- Proficient in data visualization platforms and regulatory intelligence tools.
- Proficiency in delivering insights from data analytics and advanced analytics tools.
- Travel: up to 15%, may exceed this travel requirement, if needed by the business.
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
- Additional incentive cash and stock opportunities (based on eligibility) may be available.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analyticsrisk modelsauditsinspectionsquality systemsdata visualizationadvanced analytics
Soft skills
communicationcollaborationnegotiationproblem solvinginterpersonal skillsinnovationflexibilityadaptability
