Bristol Myers Squibb Hiring for Manager, Quality Assurance Engineering CSV job in Summit Full Time

The Manager, QA Engineering (CSV) role is responsible for providing quality oversight for Site CSV activities in accordance with BMS policies, standards, procedures and Global cGMP in a fast-paced, highly collaborative clinical and commercial manufacturing facility producing cell therapy CAR T and drug products. Functional responsibilities include ensuring accurate and timely review of validation and qualification documents for all CSV equipment, computerized systems; ensuring accurate and timely review of technology transfer documents; ensuring accurate and timely review of investigations and evaluation of change controls.

Note: This Manager, QA Engineering (CSV) role applies to a people manager. When fulfilling the people manager role, the Manager, QA Engineering (CSV) is responsible for leading the team, with distinct roles and responsibilities, in maintaining alignment between business process owners, end users, and other cross functional groups/areas.

Shift Available:

Monday-Friday day shift

Responsibilities:

• Able to support activities for the QA Engineering group as assigned.
• Supports the Qualification and Validation activities in relation to QC and manufacturing equipment, utility and facility design.
• Able to provide adequate review of system GMP documents (operational and maintenance procedures, forms etc.).
• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
• Supports ECQ, Facilities, QC and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis and corrective/preventive actions are documented and implemented.
• Ensures compliance with the site validation master plan, assists with facility start-up operations and product transfers supporting the Qualification and Validation teams.
• Ensures site is compliant with global and regulatory data governance and data integrity requirements.
• Works with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.
• Ensures procedures are adequate to review and confirm appropriateness of data.
• Reviews/approves of equipment/utility/facility related deviations/discrepancies.
• People manager should have the ability to coach and develop direct reports.

Knowledge & Skills:

• Must have GMP, Quality, and in-depth risk management knowledge.
• Experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/utility/facility qualification documentation.
• Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva, Infinity/Valgenesis).
• Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
• Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
• Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
• Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
• 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.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
• Able to fully interpret complex results and situations with a degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally.
• Drives continuous improvement and improves efficiency and productivity within the group or project.
• Effectively communicates internally within the function and with internal and external cross functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional 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.
• Able to resolve complex issues with minimal direction from management.
• Work is self-directed.
• Is a recognized Subject Matter Expert within the group.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Has advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge.
• Understands fundamental scientific problems.
• Understanding of CAPA’s and root cause analysis (RCA).
• Able to write and review reports with clarity and brevity.

Basic Requirements:

• B.S. degree required.
• Minimum of five years of experience in the pharmaceutical industry.
• Minimum of 5 years of experience in CSV.
• Minimum of 2 years of experience in Quality Assurance.
• Minimum of 1 year of experience in leadership.

Preferred Requirements:

• Cell therapy experience.
• Change control experience.