Associate Director, Manufacturing Compliance

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

The Associate Director, Manufacturing Compliance role will ensure initiatives related to production readiness and compliance are optimized and executed appropriately in the areas of GMP production. In addition, this position owns management of investigations, inspection readiness and key Manufacturing owned programs like Aseptic Process Validation. This position will support both Clinical and Commercial production. This role will be expected to work both independently as well as with cross functional team members to achieve success.

Job Duties and Responsibilities

• Coach operators in high quality deviation write-ups and appropriate CAPA development/effectiveness checks; drives manufacturing deviations to on-time closure and works with team to assure an overall reduction in deviations.
• Ownership, inclusive of quality and timeliness, of Manufacturing Support Deviations, CAPAs, Change Controls, Reports and SCARs
• Lead the preparation of monthly, quarterly, and annual support and compliance manufacturing metrics. Supporting trending and data analytics with MSAT
• Lead MFG role during internal audits and regulatory inspections. 
• Contribute to risk analysis and mitigation plans to ensure product quality
• Lead efficient and effective cross functional collaboration discussions with Shift Managers, MS&T and QA.
• Assist MS&T with protocol development, authorship, and execution including PPQ protocols
• Contribute to writing and review of regulatory filings
• SOP ownership for Manufacturing support, and Equipment 
• Business owner for MFG equipment – support onboarding, validation, operations
• Responsible for ensuring alarm monitoring and reconciliation is performed in a timely fashion.
• Attend and actively participate in waste walkthroughs, 5S, Gemba walkthroughs, kaizen events, or any other operations, lean six-sigma, quality, safety, or environmental training/initiatives, as required.
• Assist Shift Manager in assigning tasks
• Support regular operation of manufacturing facility and responds to issues as needed
• Work closely with the Maintenance and Supply teams to ensure that spare parts, tools and equipment are available to complete all assigned PM, calibration or emergency maintenance tasks on equipment, facilities, and systems.
• Manage / coordinate contract service providers; including GMP cleaners includes scheduling, ensuring providers have been trained on required SOP's,
• Liaison with Engineering to ensure all PM, calibration, and emergency maintenance work and documentation is performed in accordance with cGMP requirements and in a timely manner.
• Ownership of the Aseptic Process Validation Program including isolator and BSC processes
• Other duties as required

Key Core Competencies

• Detailed knowledge of ICH, FDA, EMA regulations for manufacturing of biologicals
• Strong cross-functional collaboration skills
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, honesty, integrity, and trust building
• Serve as an ambassador for SMPA and key partnerships
• Professional behaviors in all dealings is essential and required
• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited directions
• Demonstrates a p