QA Specialist

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Quality Assurance Specialist. The Quality team at Sumitomo Pharma America, Inc. takes pride in leading compliant and innovative approaches to the development and commercialization of life-saving therapies. Sumitomo Pharma America, Inc. is building a regenerative medicine manufacturing facility in Morrisville, NC to support both commercial and research needs, and the Quality team is growing significantly. We are looking for a Quality Assurance (QA) Specialist to be a key member of our Quality Operations team, as well as support the Quality Systems, Quality Control and Quality Compliance functions. 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 success in the pharmaceutical industry is expected; experience in the development or commercialization of biologics and advanced therapies is a plus. Importantly, we seek an aspiring professional with potential and desire to grow within the company.

The successful candidate 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 build-out of our regenerative medicine manufacturing facility. This critical role will report to Associate Director of Quality Operations 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. Given the small company and dynamic nature of the work, the successful candidate must be agile and have strong interpersonal skills, with an ability to maintain focus on efficiently advancing innovative medicines addressing rare and often fatal diseases.

Job Duties and Responsibilities

• Provide Quality support for the build out of the Sumitomo Pharma America, Inc. Regenerative Medicine Manufacturing facility, initially including asset enrollment in the CMMS system, approving SOPs and Master Batch Records, and providing oversight of Engineering Runs

• Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence, review and approve GMP documentation, including but not limited to Batch Records, Specifications, Standard Operating Procedures, Deviations, CAPAs and Change Controls.

• Proactively assess and identify risk for mitigation and communication to stakeholders.

• Advise and direct on the interpretation and implementation of regulations, guidelines, company procedures, and standards for the Sumitomo Pharma America, Inc. Quality Management System.

• Ensure a state of inspection readiness at our internal manufacturing facility; provide Quality support and audit management during Agency inspections.

• Support the Sumitomo Pharma America, Inc. Quality Management System, including but not limited to processes for Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity.

• This role will initially be weekdays (Monday to Friday) but will transition to alternating shifts that include weekends as we initiate commercial manufacturing (planned for 2024).

Education and Experience

• B.S. in chemistry, biological or pharmaceutical sciences, or related discipline

• At least 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.

• Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.

• Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry.

• Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence.

• Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.

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 $85,000 to $95,000. 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.

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.

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