Head of Biologics Quality, Internal Sites
Provide strategic & operational direction to assure products are manufactured, tested, stored and distributed in accordance with regulatory & company standards, guides and procedures, and meet the requirements of worldwide regulatory agencies at designated BMS biological manufacturing and testing facilities by executing sound quality & compliance management and oversight systems.
Creates and maintains a high level of commitment to quality and compliance.
Understands the regulatory environment and works proactively to assure that the state of the industry is anticipated and maintained.
Oversee systematic implementation of programs to assure compliance with principles of current GMPs, and to proactively ensure exceptional quality and compliance performance to prevent regulatory actions.
Communicates effectively and builds cooperative working relationships with GMS sites on technical and quality matters.
Interfaces with members of senior management.
Maintains positive relationships inside and outside of the Company, including regulatory agencies and BMS business partners.
Leads and develops staff to achieve professional growth and attain established goals and a robust succession plan.
Develop remedial action for staff not meeting standards.
Develops/revises policies, directives, and procedures.
Implements systematic CAPA plans.
Anticipates regulatory trends and establishes systems to minimize GMP compliance site and Company impact.
May lead fact finding and other critical investigations and makes recommendation for escalation to the Product Review Committee for contemplation of market action.
Maintains oversight of departmental spending and head count.
Determines merit salary actions for staff.
Participates and contributes to site and Global Biologics Quality Council to ensure Management with executive responsibility is appropriately informed and aware of the suitability and effectiveness of the quality system and significant events.
Approves site Quality Plans.
Ensures that sites are inspection-ready at all times and attends site inspections as required.
Oversees the generation of the written response to regulatory inspection findings and submits to Head of Bio Quality and Legal for review and endorsement.
Ensures potential regulatory reportable problems are identified and reported to global health authorities as required.
Oversees the generation of the regulatory report and submits to Head of Bio Q & Legal for endorsement.
Qualifications 20
years of experience supporting commercial biological drug substance and drug product manufacturing operations.
Degree in a science or engineering discipline required; advanced degree preferred.
Expertise in biological manufacturing, Quality and global regulations necessary for appropriate risk-based decision making and a proactive means of identification and control of potential quality issues.
Demonstrated technical expertise in BDS and drug product manufacturing and control strategies with aseptic experience that extends to finished drug product; combination drug product expertise desired.
Experience as the quality leader for a biological manufacturing site with experience in a regional leadership role.
An understanding of business aspects of biological product operations and a highly regulated industry, as well as the relevant implications in evaluating the potential broader impact of decisions.
Significant experience with global regulatory authority interactions, including inspections and response strategies.
Significant experience developing and leading high performing teams and ability to influence leaders at all levels in the organization.
Significant experience establishing and implementing a collective strategy/vision that incorporates sites regionally/globally and translating and communicating strategy/ideas that resonate at every level.
Experience fostering a continuous improvement mind set Excellent verbal and written communication skills.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1405295.
Estimated Salary: $20 to $28 per hour based on qualifications.
Creates and maintains a high level of commitment to quality and compliance.
Understands the regulatory environment and works proactively to assure that the state of the industry is anticipated and maintained.
Oversee systematic implementation of programs to assure compliance with principles of current GMPs, and to proactively ensure exceptional quality and compliance performance to prevent regulatory actions.
Communicates effectively and builds cooperative working relationships with GMS sites on technical and quality matters.
Interfaces with members of senior management.
Maintains positive relationships inside and outside of the Company, including regulatory agencies and BMS business partners.
Leads and develops staff to achieve professional growth and attain established goals and a robust succession plan.
Develop remedial action for staff not meeting standards.
Develops/revises policies, directives, and procedures.
Implements systematic CAPA plans.
Anticipates regulatory trends and establishes systems to minimize GMP compliance site and Company impact.
May lead fact finding and other critical investigations and makes recommendation for escalation to the Product Review Committee for contemplation of market action.
Maintains oversight of departmental spending and head count.
Determines merit salary actions for staff.
Participates and contributes to site and Global Biologics Quality Council to ensure Management with executive responsibility is appropriately informed and aware of the suitability and effectiveness of the quality system and significant events.
Approves site Quality Plans.
Ensures that sites are inspection-ready at all times and attends site inspections as required.
Oversees the generation of the written response to regulatory inspection findings and submits to Head of Bio Quality and Legal for review and endorsement.
Ensures potential regulatory reportable problems are identified and reported to global health authorities as required.
Oversees the generation of the regulatory report and submits to Head of Bio Q & Legal for endorsement.
Qualifications 20
years of experience supporting commercial biological drug substance and drug product manufacturing operations.
Degree in a science or engineering discipline required; advanced degree preferred.
Expertise in biological manufacturing, Quality and global regulations necessary for appropriate risk-based decision making and a proactive means of identification and control of potential quality issues.
Demonstrated technical expertise in BDS and drug product manufacturing and control strategies with aseptic experience that extends to finished drug product; combination drug product expertise desired.
Experience as the quality leader for a biological manufacturing site with experience in a regional leadership role.
An understanding of business aspects of biological product operations and a highly regulated industry, as well as the relevant implications in evaluating the potential broader impact of decisions.
Significant experience with global regulatory authority interactions, including inspections and response strategies.
Significant experience developing and leading high performing teams and ability to influence leaders at all levels in the organization.
Significant experience establishing and implementing a collective strategy/vision that incorporates sites regionally/globally and translating and communicating strategy/ideas that resonate at every level.
Experience fostering a continuous improvement mind set Excellent verbal and written communication skills.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1405295.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
