Senior QA Specialist, Strategic Development

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The job details are as follows:
Who We Are
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
The Senior QA Specialist, Strategic Development is responsible for Quality Assurance activities related to Strategic Development programs in adherence with company policies and procedures, and phase appropriate current Good Manufacturing Practices (cGMP).
Perform the review and disposition of executed batch records and associated manufacturing/packaging documentation for clinical trial material and IND/NDA supporting batches
Perform review of quality control final product, combination product release and stability data
Communicate with Quality Assurance, Quality Control, Regulatory Affairs, Strategic Clinical Development, and other departments as needed to complete Quality related tasks
Collaborate and support quality events, CAPAs and change controls, as assigned, to support cGMP processes
Create and revise standard operating procedures (SOPs) and work instructions
Participate in CMC product development activities/meetings as it relates to Quality work
Work independently to interpret data and solve complex quality issues with minimum guidance with internal and external partners. Escalate unresolved issues or concerns to Quality Management.
Perform review of product development reports, method development reports, method validation reports, and other technical reports, as assigned
Collaborate closely with Strategic Development Quality management to ensure critical project timelines are met
Assess, review, and adjudicate temperature excursion events related to Clinical Trial Material (CTM) and Clinical Retain Samples (CRS)
Other related responsibilities as assigned
Minimum Requirements
Education and Experience requirements:
Bachelor’s degree in science/engineering, and 5+ years of relevant pharmaceutical industry experience in a cGMP environment, or
Master’s degree in science/engineering, and 3+ years of relevant pharmaceutical industry experience in a cGMP environment Will consider commensurate experience and/or combination of education and experience.
Ability to work independently and part of a team, being able to manage and prioritize workloads, stressful situations, and deadlines based on business needs, compliance and product risk
Experience in review of batch records
Ability to interpret technical data in relation to applicable procedures/specifications as well as phase appropriate current GMP requirements
Ability to handle confidential company data, projects, information, etc.
Ability to effectively communicate (written and oral) internally and externally at various levels in the organization
Proficient with Microsoft Office and Adobe Acrobat applications
Knowledge of GxP systems (Trackwise, MasterControl, Veeva Vault) and SAP
Preferred Qualifications
Master’s degree in science/engineering
Experience with combination products
Familiarity with regulatory guidance documents
Job Location
United Therapeutics requires this role to be 100% onsite in our Silver Spring, MD office.
The salary range for this position is $92,500 - $125,000/yr and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
#LI-DNI
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.