This position reports directly to the Vice President, Regulatory Compliance and External Engagement and is responsible for working collaboratively across GPS and specifically across Global Integrated Quality in order to establish and monitor leading and lagging indicators of GxP compliance and performance across the product lifecycle. The GPM and PRC Lead will provide strategic support and guidance to monitor our QMS performance across the product lifecycle. The GPM and PRC Lead is responsible for advancing a Compliance Excellence mind set and has a unique opportunity to lead transformational change along GPS’ journey to a culture of excellence and working across the Global Integrated Quality organization to streamline and simplify by taking an end-to-end integrated approach to quality and compliance across the product lifecycle. In addition, the GPM and PRC Lead will be responsible for maintaining the PRC process and for coordinating and assisting the functional quality leads in any market action decisions. The GPM and PRC Lead will act under the direction of the Vice President, Regulatory Compliance and External Engagement and will act as the Center of Excellence on market action activities. The GPM and PRC Lead will work collaboratively with the External Engagement Leader as well as the Regulatory Compliance Leaders to assess current performance to ensure that BMS meets and/or exceeds GxPs. The GPM and PRC Lead will also work collaboratively with the Regulatory Compliance Leaders and the External Engagement Leader as well as across the GxP network to refine and monitor quality and compliance operational leading and lagging performance indicators across the network implementing and advancing compliance action plans, as needed, and seeking opportunities to work collaboratively with peers and other stakeholders to proactively identify areas for enhancement and develop and implement cohesive solutions that benefit the broader organization.
MAJOR DUTIES AND RESPONSIBILITIES
The GPM and PRC Lead reports directly to the Vice President, Regulatory Compliance and External Engagement, with job responsibilities that include but are not limited to:
Oversee activities associated with the Governance and Performance Management program, including acting as the Product Review Committee’s Coordinator.
Provide strategic leadership and tactical support for the administration of the governance system for the entire QMS across the product lifeycle to ensure the overall effectiveness, efficiency and compliance to Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices for clinical supplies and commercial supply as well as Good Distribution Practices for Drugs and Devices. Responsibilities will include serving as the administrator for the Tier 1 governance council as well as serving as the operations lead for one or more Tier 2 governance councils, including setting agendas, issuing minutes, tracking Quality Initiatives and actions and aligning strategy with the co-chairs for their area of accountability and aligned with Tier 1.
Provide direction and critical input in setting, monitoring, and analyzing key performance indicators across areas of the QMS for Tier 2 and ensure alignment with applicable Tier 3 Quality Councils. Work horizontally across Tier 2s to analyze and integrate metrics data across GxP for review at Tier 1 with appropriate risk mitigation strategies centered around health of the QMS, products in development and in commercial supply. Work with BI&A and IT to develop and implement improved mechanisms for metrics monitoring, analysis and reporting with cutting edge data analytics and technology solutions.
Work collaboratively with the Regulatory Compliance Leaders, External Engagement and other functional GxP leaders to refine and monitor quality and compliance operational leading and lagging performance indicators across the network, review periodically compliance and quality operational metrics across the GxP network to proactively identify emerging trends, including the development and implementation of appropriate action plans to ensure continuous improvement and to ensure compliance now and in the future.
Develop and maintain partnerships across the end to end product lifecycle to identify and implement opportunities to advance current performance.
Seek opportunities for simplification and efficiency across the GxP network.
Working with VP, Regulatory Compliance and External Engagement, oversee the Quality Council Tier Process and ensure that it is operating as intended.
Working with VP, Regulatory Compliance and External Engagement, serve as the Tier 1 Quality Council Administrator, helping to set agenda, maintain the charter, prepare the minutes, track any actions and ensure communication across network, up and down as well as across internal and external sites.
In conjunction with the Regulatory Compliance Leaders, External Engagement Leader and the functional Quality leaders, responsible for tracking and trending metrics, identifying risks and proposing actions, as appropriate.
Ensures alignment and communication to and from and across Tier 1, Tier 2, Tier 3 Quality Councils.
Responsible for tracking and trending all quality improvement plans and transformative initatives, as appropriate,, including the Quality Plan.
Working with VP, Regulatory Compliance and External Engagement and across the GxP network, generate new approaches to advance a Compliance Excellence mindset.
Seek opportunities to work collaboratively with peers and other stakeholders to identify areas for enhancement and develop and implement cohesive solutions that benefit the broader organization.
Inspire transformative thinking and motivate employees to deliver transformative performance
Lead and/or participate in the sharing of best practices and lessons learned to embrace evolving regulations/expectations.
As a member of the Regulatory Compliance and External Engagement Leadership team, collaborate across sites and with headquarters staff to standardize and improve processes.
Recruit and train staff to carry out all functions of the Governance and Performance Management department. Periodically review the performance of and coach in real-time, direct reports with regard to the achievement of goals, objectives and BMS Core Behaviors.
Manage departmental operational expenses in alignment with allocated budget.
Manage alignment and allocation of resources to ensure adequate and timely support.
Identify opportunities for continuous improvement.
Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
This is intended to be a general job description and should not be construed as all inclusive.
KNOWLEDGE / SKILL
B.S. or BA
Knowledge of business analytics highly desirable.
Master or advanced degree preferred.
Experience / Knowledge Desired:
Minimum of 15 years of experience in the biopharmaceutical Industry in a Manufacturing, Quality, Technical, or Regulatory position or a combination thereof and/or working with a regulatory health authority.
Ability to identify and implement phase-appropriate compliance strategies to support the E2E product lifecycle.
Demonstrated ability to apply effective risk management approaches that provide a proactive means of identification and control of potential quality issues.
Demonstrated experience leading through influence and working in cross functional / matrix teams to investigate and manage quality and compliance related issues.
Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
In-depth knowledge of quality systems principles and applications.
Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
Excellent oral and written communication skills.
Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
Pragmatic in approach with demonstrated ability to make sound, risk-based decisions
Staff management experience, responsible for a department(s), planning, budgeting, and performance review is desirable.
Periodic travel (up to 25%) may be required, to include infrequent international travel to other BMS sites.