Associate Director, Clinical Inspection Management
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Inspection Lead will work in the R&D Quality (RDQ) Clinical Inspection Management group. This group conducts inspection risk assessments, prepares for and coordinates all types of Good Clinical Practice (GCP) inspections (including routine, directed or submission related inspections), and leads business critical GCP inspections. This role reports to the Head of Clinical Inspection Management.
Key Responsibilities and Major Duties:
Maintains audit currency by conducting GCP audits, as assigned.
Provide advice and counsel concerning GCP regulatory requirements.
Collaborates with industry colleagues through benchmarking of regulatory activities to influence regulatory inspection approaches.
Prioritizes and focuses on matters of significance.
Maintains an in-depth knowledge of governmental regulations affecting GCP and development of medicines.
Builds and maintains strong relationships and productive relationships with key stakeholders throughout BMS.
Influences on matters that affect quality and compliance in GCP activities.
Provides mentoring for new Team staff, as assigned.
Represents RDQ position during internal and external meetings.
Act as an advisor and back-up to the Head of Clinical Inspection Management.
Leads/ to HA inspection dossier preparation and document compilation/QC.
Influences, anticipates, and acts on trends and changes in the international regulatory environment and new developments internally and externally in the GCP area to adapt inspection readiness, as needed.
Minimum of BA/BS degree (University Graduate) in relevant discipline (life sciences degree preferred).
8 years in the pharmaceutical industry or equivalent experience with demonstrated technical knowledge of the GCP areas subject to inspection and audit.
Comprehensive demonstrated working knowledge of principles and concepts of QA, including those related to Quality Risk Management (QRM), critical thinking and QbD (Quality by Design); consistently identifies and escalates areas of highest risk.
Comprehensive GCP auditing and inspection management skills covering a wide range or specialized auditing functions for a specific technical area(s).
Comprehensive knowledge of ICH-GCP Guidelines and other international GxP regulations, as appropriate.
Detailed and comprehensive understanding of the drug development process and risk analysis.
Broad working knowledge of other disciplines.
Skilled negotiator, able to effectively influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management.
Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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