Vice President

Description:

Position Summary

The Vice President, Corporate Quality will provide strategic quality and compliance leadership in the GxP* development and implementation of an integrated Quality Management System (QMS) across the Enterprise inclusive of Research & Early Development, Global Drug Development, Global Product and & Supply and Medical Affairs and in support of the product lifecycle.

The QMS must ensure that its effectiveness and efficiency from a performance perspective is managed and continuously improving to maintain compliance to current and evolving global regulatory requirements and regulations and in keeping with external industry trends inclusive or audit, inspection and KPI measurements.

Design and implement internal processes and communication mechanisms to assess emerging global regulatory expectations for impact on the organization and the overall BMS quality management system, to ensure ongoing compliance. Ensure these processes are linked to the broader regulatory policy forums in BMS at the enterprise level. Actively engage with regulators and industry peers in industry associations, working groups, etc. representing BMS strategic initiatives and input.

Key Responsibilities

• Establish a single, integrated Quality Management System across the product lifecycle with a process-centric orientation such that continuous improvement remains central to building and sustaining an effective QMS long term. Build and develop a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPS and Commercial.

• In collaboration with the Quality Leadership Team, ensures that measurement systems are in place and actively monitoring for corrective and preventative actions to drive continuous Improvement for the integrated GxP QMS.

• Communicates effectively and builds cooperative and supportive working relationships across the Divisions and with external partners on quality, compliance and regulatory matter. Interfaces with members of the Divisional Leadership teams and the Quality Leadership Team. Engages and presents to BMSLT, CEO and BoD at the request and direction of CQO.

• Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events to the company. Builds and deploys Culture of Excellence plans to improve a culture of Quality across BMS.

• Proactive analysis of adherence to QMS through risk based internal audits, monitoring and management of regulatory inspections and assimilation of global metrics and oversight of Quality Councils

• Represents BMS across industry and regulatory QMS forums to drive/leverage best practices, share knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS.

• Chairs the QMS Governance Forum responsible for overseeing the QMS operating model.

Qualifications & Experience

• Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience.

• Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies.

• Experience in leading a major quality discipline with GxP quality experience.

• Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices).

• International regulatory experience in GxP environment.

• Previous experience dealing with FDA and other major regulatory agencies.

• Managed a large global operation involving diverse cultures and employees.

• Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management.

• In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees.

• Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations.

• Experience with managing a large budget.

• Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality.

• Position may require 20-30% travel on occasion.