RDQ CTQA CTIM Inspection Lead

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. Key Responsibilities and Major Duties Inspection readiness and preparation Acts as CTQA Inspection Lead for high risk submissions, contributing to inspection readiness strategy and activities. Conducts assessments that determine risk of upcoming inspection to guide resourcing and readiness efforts. Ensures required business stakeholders and GQ are notified of anticipated and announced GCP inspections. Creates and maintains an inspection tool box to facilitate the coordination of worldwide Health Authority GCP inspections. Ensures strategic inspection preparation with all stakeholders focused on areas of highest impact through e.g. the conduct of mock inspection and preparation of story boards. 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 pre-inspection visits and/or sponsor assessments, as needed. Leads/ to HA inspection dossier preparation and document compilation/QC. Engages GPO on inspection support. Ensures all GCP inspections are tracked and entered into QMS Inspection management and follow-up Leads key regulatory agency inspections of high risk and impact to the company, including anticipating issues that may pose risk, and provides strategic input into SME(s) to be engaged and BMS position on inspection responses. Reviews and approves all documents and responses shared with inspectors to mitigate potential risks and ensures appropriate stakeholders are involved. Facilitates collection of responses to inspection findings, critically evaluates proposed CAPAs, and maintains oversight of health authority commitments. Influences the way inspections are conducted by the Health Authorities through being a constructive partner in improving future ways of working. Monitors the GCP landscape for new trends in inspection focus in partnership with PEARL, GROe and stakeholders. Identifies trends and ensures lessons learned from inspections to proactively prevent risks in future submissions. 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. Overall 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 and GPO throughout BMS, across RDQ and with GCCCI. 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. Act 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 (Co-) Inspection Leads and RDQ-CTQA Auditors Interactions with audit function and risk functions in RDQ to be informed about identified risks and to share areas of future focus Internal stakeholders; e.g. technical, supervisory and 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 Applicable GPS and GDO personnel, related to initiatives or processes for which the incumbent is involved as the lead or as the GQ CTQA Subject Matter Expert List of minimum requirements 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 at least 8 years in the pharmaceutical industry or equivalent. Minimum 6 years technical auditing/inspection management and/or related experience; GCP auditing/inspections preferred Competencies – knowledge, skills, abilities, other: 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 in stakeholder organizations, effectively influencing and supporting improvements in products, processes and services Excellent oral and written communication kills including ability to clearly articulate information and interact effectively with cross-functional team members and health authority inspectors Skilled negotiator, able to effectively influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management Very effective in the management of potentially volatile situations Excellent critical thinking skills, excellent prioritization and sound judgement Demonstrated strength in anticipating, evaluating and solving multiple problems with varying degrees of complexity for CTQA and stakeholder functions Excellent presentation skills, ability to deliver focused messages to audience of peers, stakeholders and health authority inspectors Demonstrates commitment to delivering high-quality work product 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 Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective 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 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.