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 SCARsLead the preparation of monthly, quarterly, and annual support and compliance manufacturing metrics. Supporting trending and data analytics with MSATLead MFG role during internal audits and regulatory inspections. Contribute to risk analysis and mitigation plans to ensure product qualityLead 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 protocolsContribute to writing and review of regulatory filingsSOP ownership for Manufacturing support, and Equipment Business owner for MFG equipment – support onboarding, validation, operationsResponsible 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 tasksSupport regular operation of manufacturing facility and responds to issues as neededWork 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 processesOther duties as required

Key Core Competencies

Detailed knowledge of ICH, FDA, EMA regulations for manufacturing of biologicalsStrong cross-functional collaboration skillsProven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, honesty, integrity, and trust buildingServe as an ambassador for SMPA and key partnershipsProfessional behaviors in all dealings is essential and required Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited directionsDemonstrates a positive, ‘can do’ and service-oriented attitude.  Strong oral and written communicator; detail-oriented with a commitment to accuracy Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks Ability to multi-task and shift priorities quickly while working under tight deadlines. Skilled in developing collaborative internal and external relationships.Capable of delivering consistently prompt, efficient, dependable, highly skilled service to multiple stakeholders

Education and Experience

A minimum of 5 years of relevant experience working in the pharmaceutical, biopharmaceutical, regenerative medicine, or medical device industry is required.10-15 + years of relevant experience in a cGMP or other regulated environment preferred.Bachelor's degree in science or engineering, or a degree in a relevant technical trade, is required.Minimum 2 years of management or cross functional project management experience in a professional setting.Minimum of 3 years of manufacturing, manufacturing sciences, or process engineering experience with late-stage programs is preferred.Previous experience working in ISO 7 & 8 cleanrooms along with isolators is preferred.Deep understanding of isolator and BSC aseptic operations is preferred.Experience at an FDA approved or late-stage cGMP manufacturing siteExperience in production batch record review, investigation of deviations, root cause analysis, effective CAPA development, good documentation practices and change control management

The base salary range for this role is $139,800 to $174,700. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

For more information about EEO and the Law, please visit the following pages:

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