Manager, Production Support presso AVEVA DRUG DELIVERY SYSTEMS INC

Description

Job Summary:

The Manager, Production Support leads the Pharmaceutical Production Support Group within a lean transdermal and oral dissolving films pharmaceutical manufacturing environment. This position is responsible for coordinating, managing, and continuously improving all production support functions across manufacturing and packaging operations, ensuring compliance with cGMP, FDA, and corporate standards.

The Production Support Group, under this leader’s direction, delivers excellence in training, technical writing, batch accountability, production logistics, KPI measurement and trending, and performance analytics. The Manager ensures production metrics are accurate, meaningful, standardized, and aligned with Lean manufacturing principles, compliance requirements, and corporate objectives. This role acts as a bridge between Production and support functions such as Quality Assurance, Engineering, Technical Services, Supply Chain, OpEx and HR to drive operational excellence, data-based decision making, and continuous improvement.

Job Responsibilities:

Leadership & Oversight

• Lead and develop the Production Support Group, ensuring robust execution of training, technical documentation, batch accountability, KPI management, and production logistics.
• Establish priorities for documentation reviews, including Standard Operating Documents (SODs), batch record revisions, training materials, qualification modules, change controls, CAPAs, and SPC workbooks.
• Provide structured onboarding support for production new hires, ensuring workforce capability and consistent qualification of operators in GMP processes (e.g., blending, coating, drying, laminating, finishing, packaging).

• Recruits, trains, develops and manages effectively the ongoing performance of their direct reports.

KPI Development & Performance Analytics

• Design, implement, and maintain KPI frameworks for People, Safety, Quality, Delivery, and Cost(PSQDC).
• Standardize and cascade KPIs from leadership to shopfloor teams, enabling transparent visual management and daily performance accountability.
• Automate data collection, SPC workbook updates, and dashboard visualization to improve timeliness, accuracy, and decision making.
• Collect, validate, and trend production, quality, and efficiency data; perform root-cause analysis on deviations; and generate routine reports for leadership reviews and monthly operating reviews.

Benchmarking & Continuous Improvement

• Research, benchmark, and implement best practices from leading pharmaceutical and regulated industries.
• Compare internal performance against external benchmarks to identify improvement opportunities.
• Collaborate with Operational Excellence/OpEx teams to align metrics and support Lean initiatives such as value stream mapping, MDI boards, and visual management.
• Facilitate structured performance review meetings and ensure metrics drive problem solving, compliance, and accountability.

Compliance & Documentation

• Ensure all executed batch records are reviewed, verified, and completed to support timely product release.
• Maintain rigorous data integrity, documentation, and audit trails in compliance with FDA, cGMP, and corporate standards.
• Collaborate with Quality Assurance to align metrics, training, and documentation practices with compliance requirements.

Production Logistics & Systems

• Monitor material flow through JDE (ERP system) to ensure accurate and efficient movement across production.
• Complete finishing plans, production SPC workbooks, and departmental scheduling as needed.
• Initiate and revise departmental documents to support operational needs.
• Provide clerical and administrative support to ensure smooth functioning of production operations.

Cross-Functional Collaboration

• Serve as the subject matter expert in performance analytics for leadership reviews and strategic planning.
• Partner with Production, Engineering, Quality, Supply Chain, and Finance teams to ensure alignment and consistency of metrics, training, and compliance.
• Train and coach managers, supervisors, and operators in interpreting KPIs, fostering a culture of data-driven decision making and continuous improvement.

Qualifications

Education

• Bachelor’s Degree in Pharmaceutical Sciences, Engineering or closely allied life sciences discipline.
• MBA preferred, but not necessary.

Experience

• B.S. degree –  A minimum of 8 years experience in the pharmaceutical manufacturing and supply industry, including 6 years progressive experience in supervisory positions in a fast-paced lean Manufacturing/Packaging environment.
• A minimum of 15 years of relevant pharmaceutical industry in a fast-paced lean Manufacturing/Packaging environment will be considered for candidates with less than a Bachelor’s degree. A minimum of 10 years progressive experience in management positions in a fast-paced lean Manufacturing/Packaging environment required.