Senior Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities)

Position Summary

The Senior Manager is responsible for providing quality oversight for Site Validation activities and Quality Control Laboratory method and equipment validation in accordance with BMS policies, standards, procedures, and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment and facility activities, support data integrity initiatives for the site.

Note: This Senior Manager, QA Engineering (Equipment/Lab Methods/ Utilities/Facilities) role may apply to individual contributor or people manager. When fulfilling the people manager role, the Senior 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

• Supports all activities for the QA Engineering group.
• Supports the Qualification and Validation activities in relation to QC and manufacturing equipment, utility, and facility design.
• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports, and procedures.
• 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.
• Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
• Works with laboratory management to ensure laboratory activities comply with global regulatory requirements.
• Ensures the site stability program meets global and regulatory requirements.
• Ensures method qualifications, method transfers, and analyst trainings meet company and regulatory requirements.
• Manage QA Engineering team and assures job objectives are met on a timely basis.

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.
• 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.
• 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 seven years of experience in the pharmaceutical or related industry.