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]
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Quality Systems Specialist. The ideal candidate will be dedicated to excellence and high performance, passionate, innovative, and eager to work in a collaborative environment. A demonstrated track record of successfully utilizing electronic quality systems in the pharmaceutical industry is expected. We seek an aspiring professional with potential and desire to grow within the company.
The Quality Systems Specialist will be an integral member of a growing Quality team and work closely with a cross-functional development team and external partners. Critical roles include ensuring compliance with regulatory requirements and company procedures and supporting the Quality Management Systems associated with the build-out of our regenerative medicine manufacturing facility. This critical role will report to Associate Director of Quality Systems within the Quality team and be instrumental to the growth and success of our department and company. We seek an individual that can complement and expand the strengths of our team.
Job Duties and Responsibilities
- Management, execution, compliance, and continuous improvement of Quality Systems including Document Management, Records Management, Training.
- Support of other Quality Systems such as Deviations, CAPAs, Change Controls and Complaints.
- Issuance of documentation such as Batch Records, Logbooks, Laboratory Notebooks, and other Controlled Documents.
- Maintenance and reporting of metrics and KPIs for Quality Systems.
- Maintain a state of QMS inspection readiness and provide support during Agency inspections.
Key Core Competencies
- Communication: must have the ability to communicate with broad audiences.
- Project Management: must have the ability to manage multiple projects and deadlines and prioritize effectively.
- Interpersonal: demonstrated ability to establish effective relationships and partnerships with key stakeholders.
Education and Experience
- A minimum of 2 years of directly related work experience required.
- Associate or bachelor’s Degree in business or scientific field preferred.
- Veeva Vault Quality experience or Veeva Platform Certified Administrator preferred.
- Understanding of Quality Systems, including Document Management, Training Management, Record Management, Deviation, CAPA, Change Control, Complaints, Audits and Regulatory Inspections.
- Ability to read, develop, and understand procedures and other controlled documents.
- Knowledge and understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and International Conference on Harmonization (ICH) guidelines.
- Highly proficient in MS Office Suite of applications.
- Good written and verbal communication skills, interpersonal skills, and technical writing skills.
The base salary range for this role is $85,000-100,000. 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:
Equal Employment Opportunity is THE LAW
EEO is the Law Poster Supplement