Job Description

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.

Inspection readiness and preparation

• Supports CTQA Inspection Lead for high risk submissions, contributing to inspection readiness strategy and activities.
• Conducts and maintains risk assessments to determine risk of upcoming inspections to support resourcing and readiness efforts, including forecasting.
• Creates and maintains an inspection tool box to facilitate the coordination of worldwide Health Authority (HA) GCP inspections.
• Supports strategic inspection preparation with all stakeholders focused on areas of highest impact through e.g. the conduct of mock inspection, preparation of story boards, SME training.
• 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.
• Conducts and/or supports pre-inspection visits and/or sponsor assessments, as assigned.
• Leads/contributes to HA inspection dossier preparation and document compilation QC.
• Coordinates and supports all RDQ CTQA responsibilities in preparation for a HA inspection.
• Supports engagement with GPO on inspection support.
• Ensures all GCP inspections are tracked and entered into QMS consistently and collaborates with RCEE to ensure accurate reporting of inspection data.

Inspection management and follow-up

• Supports key HA inspections of high risk and impact to the company, including the management of all logistical aspects.
• Reviews/coordinates the review of all documents and responses shared with inspectors to mitigate potential risks and ensure appropriate stakeholders are involved.
• Supports collection of responses to inspection findings and tracks HA commitments.
• Leads back room inspection activities or functions as the scribe.
• Monitors the GCP landscape for new trends in inspection focus in partnership with PEARL, GROe and stakeholders, as assigned.
• Identifies trends and ensures lessons learned from inspections to proactively prevent risks in future inspections.
• Reviews results/analyses of GCP inspections, including inspections of clinical investigator sites, vendors, and sponsor systems to assess regulatory compliance and, where appropriate, addresses issues with BMS management to assure proper follow-up and resolution.

Metrics & Analytics

• Conducts quality review of GCP audit and inspection data in the audit management system
• Serves as data steward for reporting GCP quality metrics (audit & inspection) for inclusion in senior leadership integrated metrics
• Supports collection of audit related information, as applicable, in support of HA inspection scope

Overall

• Maintains audit currency by conducting GCP audits, as assigned.
• Provides advice and counsel concerning GCP inspection practices.
• 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 and productive relationships with key stakeholders throughout BMS (i.e. RDQ, GCCCI, RCEE).
• Influences on matters that affect quality and compliance in GCP activities.
• Provides mentoring for new RDQ-CTQA staff, as assigned.
• Represents RDQ-CTQA position during internal and external meetings.
• Acts as an advisor and back-up to the Head of Clinical Trial Inspection Management

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Supervisory Responsibility

Not Applicable

Key Stakeholders/Contacts

• RDQ-CTQA Management 
• Inspection Leads and RDQ-CTQA Auditors
• Interactions with audit function and risk leads in RDQ to be informed about identified risks and to share areas of future focus
• Therapeutic Area Quality
• RCEE
• GxP inspection functions, as applicable
• Internal stakeholders; e.g. subject matter experts, management personnel
• External stakeholders: e.g. vendors, investigator sites

External auditors from partner companies and health authority inspectors during the conduct of health authority inspections

Degree/Certification/Licensure

Minimum of BA/BS degree (University Graduate) in relevant discipline (life sciences degree preferred)

Experience – Responsibility and minimum number of years

Demonstrated expertise and specific technical knowledge of the GCP areas subject to inspection and audit, as evidenced by a minimum of 2 years in clinical QA auditing/inspection management and / or 4 years of work experience in clinical research and/or GCP related QA environment

Competencies – knowledge, skills, abilities, other

• Demonstrated working knowledge of principles and concepts of QA including those related to Quality Risk Management (QRM) and Critical Thinking
• Solid GCP auditing and/or inspection management skills covering a wide range
• Solid working knowledge of ICH-GCP Guidelines; solid understanding of applicable worldwide clinical research requirement/regulations
• Solid understanding of the drug development process and regulatory environment
• Comprehensive business and technical knowledge/experience to improve products, processes and services
• Strong oral and written communication kills including ability to clearly articulate information and interact effectively with cross-functional team members
• Able to communicate with auditees and stakeholders within RDQ and across R&D primarily related to the conduct of GCP, vendor and system audits and/or inspections
• Strong dictation/ scribing skills during interactions with native and non-native English speakers
• Build collaborative cross-functional relationships
• Strong negotiation and influencing skills
• Gains support for ideas or positions on difficult issues
• Demonstrates strong critical thinking skills and sound judgement
• Able to prioritize tasks appropriately and provide recommendations or take decisions in a timely manner under challenging circumstances
• Proactively identifies problems and implement/lead solutions; Anticipate issues / challenges and creates/implements contingency plans as appropriate
• Good presentation skills, deliver focused message to audience of peers, stakeholders and health authority inspectors
• Demonstrates commitment to delivering high-quality work product
• Knowledge of relevant governing policies and procedures
• Maintains the confidentiality and security of information, data, documents and records
• Able to function independently within an environment that relies heavily on technology for information and communication
• Sense of diplomacy and discretion
• Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment
• Fluent in English â€¢Ability to manage competing priorities
• Ability to lead change processes within functional group
• Possesses detailed knowledge of areas of expertise and could teach or mentor others

Develops and applies new methods and ideas to enhance performance Software that must be used independently and without assistance (e.g., Microsoft Suite)

Demonstrates computer literacy; Microsoft Suite, SharePoint, Veeva Vault, other systems as assigned/applicable

BMS BioPharma Behaviors Required

• Passion
• Accountability
• Innovation
• Urgency
• Integrity
• Inclusion

Working Conditions

Travel Required

Approximately 15% travel to manage inspections and attend professional meetings and seminars

Overnight Absences

Approximately 3 days per month

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.