Associate Director, GPM Integrator
This position reports directly to the GPM and PRC Coordinator and is responsible for working collaboratively across a portion of GxPs in order to establish and monitor leading and lagging indicators across GxP compliance and performance across a portion of the product lifecycle. The GPM Integrator will provide tactical support and guidance to monitor our QMS performance across a portion of GxPs. The GPM Integrator will refine and monitor quality and compliance operational leading and lagging performance indicators across a portion of the GxP continuum, proposing and implementing 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.
The GPM Integrator 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.
Major Duties and Responsibilities:
The GPM Integrator reports directly to the GPM and PRC Coordinator,
- Oversee activities associated with a portion of the GxP Governance and Performance Management program, including participating and coordinating certain Quality Councils.
- Provide tactical support for the administration of the governance system covering certain GxPs and coordinate with other Quality Councils covering the other areas (e.g., GLP, GCP, PV, GMP and GDP) to ensure consistency and inter-connectedness across the product lifecycle to ensure the overall effectiveness, efficiency and compliance. Responsibilities will include serving as the administrator and 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.
- Working with the GPM and PRC Coordinator and with respect to a portion of the GxP network,
- 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 GxPs 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 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 network.
- In conjunction with the GPM and PRC Coordinator, Regulatory Compliance Leaders, External Engagement Leader and the functional Quality leaders, responsible for tracking and trending metrics, identifying risks and proposing actions, as appropriate for a portion of the GxP network.
- Responsible for tracking and trending all quality improvement plans and transformative initatives for a portion of the GxP network, as appropriate.
- 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.
- Collaborate across the network to standardize and improve processes.
- B.S. or BA
- Knowledge of business analytics highly desirable.
- Master or advanced degree preferred.
Experience / Knowledge Desired:
- Minimum of 8-10 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