Manager, QA Engineering

Manager, QA Engineering

The Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) role is responsible for providing quality oversight for Site Technology Transfer 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 equipment, computerized systems, utility, and facility activities; 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 (Equipment/Lab Methods/ Utilities/Facilities) role may apply to individual contributor or people manager. When fulfilling the people manager role, the Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) 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.

Duties/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.

Qualifications

Specific Knowledge, Skills, Abilities:

• 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 Computer Maintenance Management System (e.g., Maximo) and quality systems software (e.g., BMSDocs Electronic Document Management System, 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 completes 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 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.

Education/Experience/ Licenses/Certifications:

• Bachelor of Science degree required.
• Minimum of five years of experience in the pharmaceutical or related industry.