Senior Manager Compliance, Manufacturing Compliance & Support

Position Summary

The Senior Manager Compliance, MFG Compliance & Support reports to the Associate Director, MFG Compliance & Support. This role is part of the overall manufacturing organization and accountable to manage the Manufacturing Compliance & Support operations activities. The Senior Manager Compliance is accountable for the contributions that directly support Manufacturing quality compliance, review board representation, and manufacturing inspection readiness. This role is responsible, in collaboration with Manufacturing management, to manage Manufacturing deviations, CAPAs, CCs, quality KPI adherence, inspection readiness, MFG business continuity, and Aseptic Process Simulation program. The Senior Manager Compliance leads a team of specialists that will work in a matrix organization to deliver on full C&S scope. The Senior Manager Compliance is expected to collaborate with other C&S managers to organize and allocate the specialists to meet business demands.

Responsibilities

Key Responsibilities

• Identifying, assessing, and prioritizing potential risks and implementing strategies to mitigate their impact, for both compliance and safety.
• Proactively drives quality record turnaround time (TAT) improvements.
• Accountable for on-time completion of MFG deviations, CAPAs, and CCs.
• POC and representative for manufacturing in all applicable cross-functional local and global review boards.
• Develop, manage, and report on manufacturing compliance KPIs.
• Coordinates corrective actions with MFG operations and C&S technical training to imbed changes into routing operations training.
• Responsible for level loading deviations throughout all C&S specialist in collaboration with C&S leadership team
• Accountable for manufacturing business continuity planning.
• Leads and/or represents manufacturing for internal/external inspections.
• Responsible for driving manufacturing inspection readiness.
• Accountable for Aseptic Process Simulation life cycle management, execution, and reporting.
• Accountable for on-time completion of effectiveness verifications of all CAPAs.

Technical Training

• Coordinates required trainings for specialists to be qualified for quality record authoring and ownership. Front Line Support.
• Accountable for receiving and processing all escalations and deviations generated from FLS.
• Develops, manages, and reports on KPIs related to MFG operational execution throughout the MFG organization.

Profile

Qualifications & Experience

• Minimum of 7 years of relevant
• manufacturing experience.
• Minimum of 5 years leadership experiences including the management of direct reports required.
• Minimum of 3 years in a Quality Assurance role managing deviations and CAPA.
• Extensive knowledge of EOHSS, cGMPs and ATMPs regulations and principles
• Demonstrated proficiency in departmental organizational development.
• Adaptable to a fast paced, complex, and dynamic business environment.
• Knowledge of lean manufacturing principles.
• Excellent communication skills

BMS
Senior Manager Compliance, Manufacturing Compliance & Support