Bristol-Myers Squibb Company

Associate Director Global Quality, Clinical Trials & Safety (GQ-CT&S) Risk Management

Location
Princeton, NJ, US
Posted
Jul 10, 2018
Ref
R1504010
Required Education
Bachelors Degree
Position Type
Full time
Purpose/Objective of the job

The AD of GQ CT&S Risk Assessments is an essential role to lead the enterprise Risk Assessments related to clinical trials. This role reports to the Head of GQ CT&S Quality Governance and Risk Assessments.

Key Responsibilities and Major Duties

Quality Risk Management
  • Leveraging core risks supporting continuous improvement of processes in compliance with Good Clinical Practices (GCP) and to drive the audit focus and strategy.
  • Leading the Quality Risk Management Process at compound level across clinical trials or interdisciplinary processes across disciplines in order to lower the risk profile.
  • Developing and implementing a predictive analytics capability to enable risk mitigations, and monitoring of the effectiveness of risk mitigations.

Overall
  • Being a recognized expert in risk management.
  • Training the in-process quality functions on QMS capabilities, such as risk assessments.
  • Partnering with the GCO Global Clinical Compliance and Continuous Improvement function and GCO business partners, to ensure the successful implementation of a QMS. Assess the performance of the QMS.
  • Prioritizing and focusing on the avoidance of risk for issues that matter.
  • Acting as a credible, influential and respected spokesperson on matters pertaining to QMS, risk assessments within the BMS organization to adopt risk minimization.
  • Driving the audit strategy at a compound level or for the clinical processes, (e.g. awareness of project timelines/priorities/risks, awareness of process level risk assessments (impact and likelihood), etc.). Establish and maintain the Project audit plan for individual programs.
  • Collaborating with the regional CT&S planners and Directors to execute the audit strategy.
  • Acting as the CT&S inspection readiness representative for given compound, ensuring inspection preparation activities are focused on areas of highest risk.
  • Acting as the primary CT&S representative on serious non-compliance issues for given compound or process.
  • Watching, anticipating and acting on trends and changes in clinical QMS, as well as new developments internally and externally to adapt risk strategy for clinical trials and processes related to clinical research, as needed.
  • Developing strong and productive working relationships with key stakeholders in the clinical and regulatory department in BMS with the ability to think strategically across a broad portfolio and effectively communicates his/her risk management views to clinical management.
  • Collaborating with the Global CTS Leadership to achieve the optimal study, process and vendor audit strategy , in accordance with company objectives, and in consultation with R&D Leadership (clinical, operations, regulatory).
  • Supporting as SME on QMS during Due Diligence.
  • Maintains an in-depth knowledge of governmental regulations impacting GCP and development of medicines.

Supervisory Responsibility

None

Key Stakeholders/Contacts
  • Regular contact with GQ CTS Strategy Roles.
  • Interactions with auditors to be informed about identified risks and to share areas of future focus.
  • Collaboration with Clinical Compliance & Continuous Improvement in Global Clinical Operations.

List of minimum requirements
  • Degree/Certification/Licensure:

Bachelor's degree required with an advanced degree preferred, Life Sciences degree preferred
  • Experience - Responsibility and minimum number of years:

Demonstrated expertise and specific technical knowledge of the GCP areas subject to audit, as evidenced by at least 10 years in the pharmaceutical industry or equivalent and 5 years in quality management.

Quality Management and Risk assessment expertise.
  • Competencies - knowledge, skills, abilities, other:

Expert in risk management;

Anticipates business and industry issues; enables product, process, system and/or solution improvements:

Understanding of pharmaceutical product development;

Understanding of global regulatory principles related to GCP and their impact on company's development and business;

Understanding of the complexities of cross functional issues;

Excellent oral and written communication and interpersonal relationship skills with ability to impact and influence people across the matrix;

Sense of diplomacy and discretion;

Maintains the confidentiality and security of information, data, documents and records;

Demonstrates commitment to delivering high-quality work product;

Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective;

Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;

Develops strong collaborative working relationships with key stakeholders;

Ability to manage competing priorities;

Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication;

Fluent in English
  • Software that must be used independently and without assistance (e.g., Microsoft Suite)

Microsoft Suite, Trackwise CAT, SharePoint, other systems as assigned/applicable
  • BMS BioPharma Behaviors Required

Passion, Accountability, Innovation, Speed

Working Conditions
  • Travel Required (nature and frequency)

Approximately 5-10 % travel to attend professional meetings, inspection activities and seminars.