Learning and Compliance Manager

Profile

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.

Partner with the PD functional areas to ensure that local GXP procedures align with 'above-site' requirements.

Lead PD matrix teams, while partnering with Global Quality, to develop end-to-end QMS procedures that ensure the agility and flexibility appropriate for a dynamic drug development environment.

Work with limited guidance to author PD-level procedural documents and develop appropriate training plans.

Synthesize feedback from subject matter experts and procedural document teams to identify and resolve issues to accurately document current and future documents.

Serve as PD's central point of contact, knowledge expert, and power-user for the electronic document management system (i.e., PDHQ).

Assist with, and act as a subject-matter expert for the creation of materials for PD-level procedural document training.

Analyze procedural document data and produce assessment reports as required for compliance using a variety of tools and formats.

Identify and lead improvements to the procedural document management process based on regulatory needs, benchmarking, and harmonization opportunities for business process improvement.

Partner with learning resources to define GxP learning content and role-based requirements and curricula.

Develop benchmarking metrics to enhance and simplify the PD procedural document management process.

Implement collaboration tools (e.g., SharePoint) to enhance PD's capabilities and expand the PD Learning and Compliance sphere of influence.

Lead, manage, and maintain the PD procedural document periodic review program.

Collaborate with Global Quality and other BMS procedural document management organizations as required.

Monitor future GXP trends in collaboration with CMC Regulatory and Global Quality thought leaders.

Lead and participate in cross-functional teams for PDHQ administration, collaboration, or others as assigned.

Manage multiple projects simultaneously, create and manage tactical project timelines, and contribute to project status meetings.

Work with communications teams to support procedural document training deployments.

Provide input to the selection of tools and technologies for procedural document management.

Negotiate complex situations without direct authority.

LCM may also be required to perform the following activities as required:

Partner with PD Functional Areas to develop and deploy role-based right-sized curricula as necessary to support the capability learning needs of PD functional areas.

Assist with PD GMP training program management that includes the development and delivery of GMP training content for PD-level audiences.

Assist with the management and facilitation of training evaluation and effectiveness.

Serve as PD secondary central point of contact and power-user for the electronic Learning Management System (i.e., SuccessFactors).

Required:

A bachelor's degree, preferably in science or engineering, with a minimum of 8 years' experience or a Master's degree with a minimum of 4 years' experience.

Minimum 6 years' experience in the pharmaceutical industry with at least 4 years in a GxP environment.

Experience working with procedural documents in a regulated technical environment and knowledge of electronic procedural document management systems, such as PDHQ, is required.

High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas.

Demonstrated ability to engage multiple stakeholders and be effective across matrix teams is required.

Proven teambuilding skills and an ability to foster partnerships across projects and multidisciplinary teams.

Demonstrated ability to resolve complex issues and differences in a creative, constructive, and diplomatic manner is required.

Proven ability to follow up on open issues and drive results to completion is required.

Exhibited ability to meet competing deadlines and multiple priorities is required.

Demonstrated success in managing projects and team effectiveness with minimal supervision is required.

Strong communication skills are required.

Strong MS Access, Excel, and SharePoint skills are required.

Ideal Candidates Would Also Have:

Strong expertise in pharmaceutical / biopharma compliance and regulatory requirements.

Strong expertise in Learning Management Systems.

Experience leading compliance programs.

Experience in drug development workflows and business practices.

Ability and willingness to build capabilities in others through cross-training.

Knowledge of other MS Office software such as PowerPoint, Teams, and Visio.

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.

Company: Bristol-Myers Squibb

Req Number: R1527600_EN

Updated: 2020-07-14 00:00:00.000 UTC

Location: New Brunswick,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com