Manager GQ-CTS Quality Governance and CAPA - Bristol-Myers Squibb - Braine-l'Alleud

Bristol-Myers Squibb

Région

Myers Squibb1,899 avis
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.

Global Quality , Clinical Trials & Safety (GQ-CT&S) is responsible for the quality governance and auditing of clinical trials and safety. GQ CT&S defines the Clinical Quality Management Systems (QMS) enabling strategies and technologies and coordinates Quality Risk management at the compound and process levels to inform the audit focus and drive implementation of Quality Risk Management. GQ CT&S audits all processes related to clinical research and pharmacovigilance, including investigator site, country, process, vendor and partner audits, to assess compliance with relevant regulations and applicable policies and procedures. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements. GQ also offers support as SME during Due Diligence and if areas of serious non-compliance are identified.

Purpose/Objective of the job

The Manager of GQ CT&S Quality Governance and CAPA is an essential role to implement the Quality Governance strategy and facilitate the enterprise CAPA process related to clinical trials and safety. This role reports to the Associate Director of GQ CT&S Quality Governance and CAPA.

Key Responsibilities and Major Duties

Quality Governance
  • Prepare analytics for the GQ-CT&S defined metrics and develop improvement suggestions in consultation with the AD of GQ CT&S Quality Governance and CAPA.
  • Support in the development of Quality Governance-related outputs, to the GQ-CT&S Leadership Team.

CAPA management
  • Executing a culture of continuous improvement through the implementation of CAPA principles.
  • Facilitating the development of root cause analysis and comprehensive corrective action preventative action plans (CAPA) for audit and inspection findings, for non-GCO and cross-functional issues.
  • Following up the CAPA development process, to ensure timely acceptance of robust CAPA plans and subsequent implementation.
  • Being proficient in CAPA management.

Overall
  • Collaborating with the GCO Global Clinical Compliance and Continuous Improvement function and other Business Compliance Functions to ensure the successful implementation of a QMS.
  • Supporting the Quality Issue management process through prioritizing and focusing on the issues that matter.
  • Acting as the (back-up) Potential Serious Breach Operational Lead.
  • Contributing to CAPA process improvement initiatives.
  • Acting as a credible, influential and respected spokesperson on CAPA within the BMS organization.
  • Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think enterprise-wide.
  • Supporting as SME on QMS during Due Diligence and if areas of serious non-compliance are identified.

Supervisory Responsibility

None

Key Stakeholders/Contacts
  • Interactions with auditors to understand the expectations for CAPA development.
  • 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 7 years in the pharmaceutical industry or equivalent and 3 years in quality management.
  • Root Cause Analysis and CAPA expertise.


Competencies - knowledge, skills, abilities, other
  • Proficient in CAPA management;
  • 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
  • Microsoft Suite, Trackwise CAT, SharePoint, other systems as assigned/applicable


BMS BioPharma Behaviors Required
  • Passion Accountability Innovation Speed

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

Société

Bristol-Myers Squibb