Senior Manager, PV Compliance and Inspection Readiness (R1558392-en-us)
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.
Functional Area Description
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Provides management for the Worldwide Patient Safety in the preparation of, organizing and responding to Good Pharmacovigilance Practice (GVP) inspections. Additionally, provides support of GVP related activities in Good Clinical Practice (GCP), Good Manufacturing Practice (cGMP) and Good Distribution Practice (GDP) Inspection readiness programs. Under the direction of management, provides additional support for internal audits of GVP systems/processes, business partner audits of GVP processes, GVP deviation investigations and PV Quality Management System (QMS) support.
Manages GVP inspections and audits in terms of proactive readiness preparation, organization and, as necessary, post-evaluation to ensure that corrective and preventative actions are authored and implemented in a timely manner.
Leads the GVP elements of GCP, GMP and GDP inspections and audits both proactively in terms of readiness preparation and post-evaluation that corrective and preventative actions are authored and implemented in a timely manner for items impacting the GVP system.
Functions as a team member or leads the support of the inspection and audit process of key business partner/distributor and CRO relations and adherence to contractual agreements in regard to GVP compliance. Additionally, effectively collaborates with external quality and compliance organizations (i.e. Global Quality) to maintain high standards of quality for the department.
Leads the individual assessments for the identification, risk assessment, investigation, and closure of GVP deviations for issues impacting the GVP system. Additionally, may contribute to the suggested remediation efforts.
Manages the metrics supporting the Pharmacovigilance Tier 3 and, as necessary, Tier 2 Quality Council reporting of issues pertaining to Audit/inspection CAPA, Inspection Readiness and deviations to senior WWPS leadership.
Manages the trending and analysis of quality issues from various sources for items impacting compliance and quality. Concisely summarizes and effectively communicates the result of analysis and intelligence with stakeholders as appropriate to address issues and prevent reoccurrence of quality and compliance issues.
Suggest improvements to the review of departmental standard operating procedures related to inspection readiness and GVP QMS.
Represents on behalf of PV Compliance and Inspection Readiness Management to partner with other internal Research & Development/BMS stakeholders to align to principles of GVP inspection readiness and GVP QMS.
Ensure all data supporting deviations and open CAPA within the Pharmacovigilance System Masterfile (PSMF) is current and of high quality to enable applicable sections to be generated in a timely manner. Escalates issues to respective functions and management for evaluation and remediation.
Supports the process for GVP inspection readiness for internal and external parties including providing comments on guidelines and regulations pertaining to inspection readiness, CAPA management and quality issue management.
Assist in the development of departmental and company standard operating procedures as it pertains to inspection preparation, audit readiness and CAPA. Participate in the preparation and conduct of departmental training, where required, to support inspection readiness and quality event/deviation investigation impacting GVP systems.
A Bachelor's degree with the minimum years of experience required. A minimum of five (5) years pharmaceutical industry experience, and with a minimum of three (3) years in pharmacovigilance, drug development, clinical development or regulatory affairs.
Prior quality, quality control, compliance and/or audit experience preferred.
Prior experience with providing guidance to senior management on regulatory and compliance issues germane to pharmacovigilance preferred.
Key Competency Requirements
Ability to support and lead CAPA development using a systematic and process driven methodology. Includes, under the direction of senior staff, the ability to utilized key root cause analysis tools/techniques (e.g. Five Why’s, Is/Is not, cause-and-effect diagram (fishbone), etc.).
Ability to support and lead deviation investigations using a systematic and process driven methodology. Includes, under the direction of senior staff, the ability to utilized key root cause analysis tools/techniques.
Ability to define and set targets for completion of tasks, both as an individual and within a team.
As a member or part of a high-performance teams, has an ability to work in a collaborative manner and work in a team/matrixed setting.
Ability to deliver on assign tasks with high standards, high productivity and meeting established standards set by department management.
Develop an in-depth knowledge of global governmental regulations that impact the research, development and marketing of medicines and devices as well as relevant Bristol-Myers Squibb Company policies and procedures associated with pharmacovigilance. Within the area of expertise, maintains awareness of industry trends and developments.
Demonstrated effective oral/written communication and strong interpersonal relationship skills for the recommendations for quality improvements of key CAPA and inspection readiness deliverables to our internal and external customers.
Occasional Travel may be required, including overnight, may be required in this position. These trips include travel to BMS sites, business partners and other locations to conduct reviews of pharmacovigilance activities, provide education/training seminars and to attend professional meetings and seminars.
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.
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