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.
PURPOSE AND SCOPE OF POSITION:
The Senior Specialist is responsible for supporting the compliance group from a Subject Matter Expert (SME) standpoint in accordance with Bristol-Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include performing approvals for manufacturing investigations, driving proactive and corrective improvements within Operations, managing the internal inspection readiness program, providing support at all regulatory inspections and corporate audits, tracking internal/external audit commitments and driving on time closure, evaluation of new requirements and emerging regulations, and oversight for trending of quality compliance metrics.
DUTIES AND RESPONSIBILITIES
Review and approve manufacturing investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
Ensure control of systems, processes and product through supporting review and approval of change notices and change control.
Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed in a timely manner.
Monitor and track external audit/inspection commitments to ensure timely closure.
Review site change controls and ensure appropriate requirements are identified and completed for implementation.
Assess global standards/policies and emerging regulations.
Responsible for issuing site metrics for compliance and adherence to global requirements.
Must be skilled in planning and organizing, decision-making, and building relationships.
Able to effectively multi-task.
EDUCATION AND EXPERIENCE (As Applicable)
B.S. degree required with a minimum of five years of Change Control experience in the pharmaceutical industry.
Deviation and CAPA-related experience preferred.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
Must be able to note technical/scientific attributes in potential situations or issues and process science based solutions across a majority of the job function.
Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Must possess an independent mindset and tenacity.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Work is self-directed.
Confident in making decisions for minor issues.
Routinely recognizes Quality issues and solves problems.
Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
Is recognized Subject Matter Expert within the group.
Provides guidance to other employees in interpretation of complex data.
Capable of providing input within the department and cross functional teams.
Builds relationships internally within and with cross functional teams.
Contributes to goals within the work group.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Able to write and review reports with clarity and brevity.
Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Able to effectively multi-task and execute project management skills.
Knowledge of US and global cGMP requirements.
Understanding of aseptic manufacturing processes.
Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
Ability to make independent and objective decisions and to work with minimal supervision.
Excellent verbal and written communication skills.
Strong Presentation Skills required in order to facilitate Change Control Review Board Meetings.
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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.