Bristol Myers Squibb Associate Director Quality Governance & CAPA in Braine L'Alleud, Belgium
Associate Director GQ CT&S Quality Governance and CAPA
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 AD of GQ CT&S Quality Governance and CAPA is an essential role to build and maintain the Quality Governance and lead the enterprise CAPA process related to clinical trials and safety. This role reports to the Head of GQ CT&S Quality Governance and Risk Assessments.
Key Responsibilities and Major Duties
Defining QMS-enabling strategies and technology to build a sustainable GCP and GVP Quality Culture.
Owning the development and maintenance of the GCP Quality Manual, in collaboration with relevant stakeholders.
Developing and implementing a culture of continuous improvement.
Driving implementation on CAPA principles.
Supporting comprehensive corrective action preventative action plans (CAPA) are developed and root cause analysis is captured, for complex cross-functional issues.
Driving the CAPA process for audit and inspection findings, to ensure timely acceptance of robust CAPA plans.
Being a recognized expert in CAPA management.
Training the in-process quality functions on QMS capabilities, such as CAPA assessments.
Partnering with the GCO Global Clinical Compliance and Continuous Improvement function to ensure the successful implementation of a QMS. Assess the performance of the QMS.
Analyzing and creating meaningful metrics and trend analyses on audit/inspection findings and related CAPAs, for reporting and escalation to management and stakeholders.
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 and CAPA both within and outside the BMS organization.
Watching, anticipating and acting on trends and changes in clinical QMS, as well as new developments internally and externally to adapt CAPA strategy for clinical trials and processes related to clinical research, as needed.
Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively communicates his/her views to senior 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 and if areas of serious non-compliance are identified.
Maintains an in-depth knowledge of governmental regulations impacting GCP and development of medicines.
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.
Bachelor’s degree required with an advanced degree preferred. Life Sciences degree preferred
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 CAPA expertise.
Expert in CAPA 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;
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
Microsoft Suite, Trackwise CAT, SharePoint, other systems as assigned/applicable
BMS BioPharma Behaviors required
Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.
Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.