Senior Director QA Operations

Manufacturing/Ops

icon-location-marker Manati - PR - US
Posted 65 days ago Full_time R1522582

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.

MAJOR DUTIES AND RESPONSIBILITIES

State the most important activities and accountabilities of this position.

 These activities and accountabilities can influence the achievement of company or business goals.  (Attach additional sheets if needed):

Serves as key member of the Site Quality Leadership team translating quality requirements, improvement and change initiatives into operating plans for the Sterile and Non-sterile operations at the Manati site. Ensures that appropriate GMP Quality Systems are in place and implemented in a sustainable manner, both through review and approval of procedures and shop floor presence, as required, and that adequate documentation exists to support and drive compliance. Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives and verifies consistency with other site procedures and/or specifications and implemented in a complaint manner at all levels of the Organization Ensures adherence to the Quality unit responsibility (WWQC 2.1 current version) and provides leadership accordingly to the QA Unit. Ensures that deviations from procedures and specifications are investigated, resolved and documented; that corrective/preventative actions are identified and implemented to avoid the occurrence/recurrence of deviations that no materials are released before the completion of the investigation and that trends are identified and corrected before having negative impact to the Operation. Interfaces with Regulatory Agencies (FDA, EMA and foreign regulatory agencies) as necessary, leads site regulatory inspections and ensure compliance with the marketing authorization requirements.  Interfaces directly with suppliers and customers, as well as Global Product Development and Supply senior management. Ensures an effective process/system for disposition of raw materials, API’s, device components, packaging and labeling materials and the involvement in the decision for Bulk Drug Substances disposition. Core Member of the site Quality Council; ensures operations are conducted in compliance with established requirements. Monitor implementation plans for any new Quality Policies, Directives and associated impact assessments and verify compliance with BMS Policies and Guidelines. Ensures that all QA personnel have adequate training, education, and experience to perform their GMP related job functions effectively.  Educates staff on complex matters such as: contamination controls, root cause analysis, combination products controls, etc. Ensure the appropriate information to and obtain the Qualified Person’s approval as required by the specific European Union (EU) regulatory authorities is provided and that all products are manufactured per the approved specifications and filed parameters. Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and notify senior management when necessary.  Works on abstract problems across functional areas of the business.  Identifies and evaluates fundamental issues for major functional areas through assessment of tangible variables.  Ensures budgets development and the preparation of periodic projections of spending against budgets; and manages and controls area spending. Direct involvement in securing regulatory filings of a facility or process and supports product submission documentation.

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.