Job Information
Sumitomo Pharma Senior Director, Cell Quality in Morrisville, North Carolina
Sr. Director, Cell Quality
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com (https://myovant-my.sharepoint.com/personal/gina_cromwell_myovant_com/Documents/Documents/072023%20Transition%20documents/JDs/Sumitomo-pharma.com) ]
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Sr. Director, Cell Quality. The Sr. Director, Cell Quality is the Site Quality Head located at our Cell Processing Center (CPC) in Morrisville, NC. The Sr. Director, Cell Quality, has overall responsibility for establishing site quality objectives, managing site quality teams, and representing Quality on clinical and commercial cell based and combination product program teams. This role interprets GxP regulations, determines quality requirements, and works closely with internal cross-functional teams and external partners to execute quality strategy to support commercial and clinical cell based and combination products/drug-delivery quality. This role fosters a quality culture and mindset for inspection readiness and continuous improvement, while supporting manufacturing facility commissioning and maintenance. The Sr. Director regularly provides quality updates and metrics in department, project, and quality management review meetings. The Sr. Director, Cell Quality has multiple direct reports and reports to the Operational Vice President, Quality Assurance.
Job Duties and Responsibilities
Provide Quality leadership on planning and execution for the build out, commissioning, and on-going support for the CPC.
Ensure and deliver Quality and Compliance oversight for manufacturing of commercial and investigational cell-based and combination products, including maintenance of combination products design history file(s).
Disposition of batches manufactured by the CPC, contract manufacturer(s), and/or partners.
Provide guidance, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and standards to direct reports and cross-functional internal and external teams.
Lead, manage, and execute ongoing maintenance and continuous improvements of site quality and systems, including but not limited to, compliance and follow through to completion of audits, documents, deviations, CAPA, change control, complaints, management review, validation, and data integrity.
Maintain and improve site quality across all areas through quality team leadership and cross-functional collaboration.
Prepare and present quality related updates, metrics, and trends at internal project, quality management review, and partner meetings.
Develop, review and/or approve GMP documentation, including but not limited to Specifications, Standard Operating Procedures, Validation Protocols and Reports, Deviations, CAPAs and Change Controls.
Maintain a prepared state of inspection readiness through training, leadership and inspection management during Agency inspections.
Lead the Quality representation for Tech Transfer of new products into CPC, including active input and decision making related to transfer strategy, protocol development, transfer execution, and final approval.
Create and maintain cell biologics–medical device combination product design history files from early-stage development through post commercialization.
Determine and ensure proper qualification, quality oversight and management of tissue source centers, treatment centers, cell and medical device CDMOs.
Key Core Competencies
Excellent written and oral communication skills
Excellent collaboration, negotiation, and team leadership skills
Team goal setting and planning to achieve results through effective staff management through a positive, engaging, and inspiring management style.
Effective application of analytical and investigational techniques to identify root cause and problem solve
Advanced knowledge of aseptic cell processing, testing, and release requirements
Support company growth through effective staff development
Education and Experience
B.S. / M.S. in microbiology, biological, life sciences, pharmaceutical sciences, or related discipline with at least 10 years QA management experience and at least 15 years related experience.
Advanced knowledge and experience in aseptic cell processing quality best practices and regulatory requirements, including 21 CFR 210/211, 600s, and 1271.
Working knowledge of 21 CFR Part 4 and combination products design history files
Prior experience interfacing with and managing inspections performed by FDA and other regulatory bodies.
Expert level knowledge of GMP regulations and FDA CBER requirements, Guidance documents, and industry best practices. FDA CDRH knowledge a plus.
Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, FDA CBER/EMA, and ICH.
Knowledge of current best practices and industry standards for tissue sourcing, biologics manufacturing; experience with advanced biologic therapies and aseptic techniques.
Physical Requirements
Position requires standing for long periods of time
Frequent work in clean room environment in clean room suit
Wearing laboratory coat and PPE, as necessary
Must be able to pass clean room gowning and aseptic technique qualification
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.
The base salary range for this role is $213,200 to 271,800. 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.
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:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com (https://www.us.sumitomo-pharma.com/) ]
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.
Our Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide
Our Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas