Manager, Quality & Inspection Readiness-2

Medical and Regulatory Affairs

icon-location-marker Uxbridge - GB
Posted 28 days ago Full_time R1516177

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  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.

Audit Management

Develop and execute audit management training for subject matter experts

Coordinate pre-audit and inspection documents including streamlining information needed from global PV functions and the safety database

Liaise with Global Quality and Regulatory Compliance (GQRC), PV International Team and other key stakeholders

Conduct mock inspection interviews focused on subject matter expert role-based content as well as general inspection conduct

Improve and implement efficient methodologies and tools for the handling of internal audits

Maintain a department Corrective and Preventative Action (CAPA) system for findings/observations due to audits, inspections, and quality events,  including developing reports for trend analysis

Maintain oversight, guide subject matter experts in developing solid CAPA, and facilitate resolution of CAPA from audits in order to prevent repeat or complex resolution to findings by liaising with GQRC, Pharmacovigilance (GPV&E) and other BMS department subject matter experts.

Contribute towards updating relevant sections of the Quality, Standards and Training Manual and quality related sections of the Pharmacovigilance Master File (PSMF) as appropriate

Promote the spirit of proactive, continuous quality improvement

Inspection Readiness

Assist with departmental inspections including developing responses to observations and oversight of corresponding CAPA

Trend and leverage industry intelligence relating to PV inspections and share results with teams in order to improve the effectiveness of the PV Quality System

Promote the spirit of proactive, continuous quality improvement

Qualifications required

Bachelors degree, Master degree Preferred, scientific/medical background  (B.S./B.A, M.S.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy

Minimum of 8 years pharmaceutical experience with a strong preference of 5 or more years in pharmacovigilance, drug development, clinical development, quality and/or regulatory.  

Excellent written and verbal skills

Excellent skills in influencing and collaborating in order to problem solve

Capable to interpret information/data to provide guidance regarding superior business solutions, largely in the form of influencing strong corrective and preventive actions as a result of audit/inspection findings

Ability to detect business and regulatory issues and develop solutions to mitigate risk

Self-starter with demonstrated ability to work independently and in a matrix, team environment

General understanding and adaptation of global safety regulatory obligations from clinical trial to post marketing phases

Appreciation of sense of urgency and prioritization of multiple projects and timelines