GRS-CMC Director CMC Operations amp Intercon Support

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Functional Area Description

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of product lifecycle. Members of the organization develop global regulatory CMC strategies and collaborate with key stakeholders to execute the strategies in alignment with business priorities. The team also performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees the TSE/BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.

Position Summary / Objective

The Director Global Regulatory CMC Operations Head will manage a team with responsibility for operational activities (e.g. regulatory information systems, compliance, LT meetings, etc.) related to Global Reg CMC. The position will be a member of the Global RegCMC LT. The group will partner with stakeholders across functional areas to enhance business processes with an overall goal of increasing efficiency and ensuring initiatives are aligned with business priorities as they relate to GRS-CMC responsibilities. The Global Regulatory CMC Operations Head will also oversee individuals managing relationships with External Regulatory Partners supporting GRS-CMC as well as activities associated with product delivery devices.

Position Responsibilities

In addition to information in the position summary, the GRS-CMC Director is responsible for the following


Coordinate and provide oversight/guidance to develop and maintain appropriate procedural documents, white papers and guidelines within GRS-CMC

Analyze and measure the effectiveness of existing business processes within the Global RegCMC department and identify opportunities to improve business practices and processes to maximize resources

Provide oversight to subject matter experts (SMEs) focused on Regulatory-CMC device regulations, including developing and managing relationships with Notified Bodies in Europe.

Work effectively with stakeholders to understand functional interdependencies, assess impact on effective processes, develop mutually agreed-upon optimized processes and drive key cross-functional initiatives and business imperatives

Develop, implement, and maintain new business processes to optimize interactions with the Intercon regulatory teams, including supporting prioritization and visibility of planned regulatory systems.

Coordinate updates to information and Knowledge Management tools to enhance collaboration and information sharing across the department.

Facilitate departmental communication strategy and preparation of announcements, communications and periodic newsletter, when needed.

Manage and actively support growth and development of 4 - 5 direct reports and their next level, as relevant.

Build strong trust-based relationships with stakeholders within the broader Global Regulatory organization, as well as, Global Manufacturing and Supply (GPS).


Degree Requirements

Minimum BA/BS Degree

Experience Requirements


Minimum 10 years pharmaceutical or related experience, prefer multidiscipline

Knowledge of CMC regulatory requirements during development and post-approval phases.

Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.

Ability to identify, communicate and resolve routine/complex issues.

Ability to identify trends & changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary.


Key Competency Requirements

Strong oral and written skills

Prior management skills preferred

Travel Required

Some travel required.

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

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