Senior QA Specialist, Strategic Development

Unither Pharmaceuticals; Silver Spring (MD); On-site; USD 93,000 - 125,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401k and ESPP

Paid time off & paid parental leave

Disability benefits

Job summary

United Therapeutics in Silver Spring, MD, seeks a Senior QA Specialist, Strategic Development to drive QA activities for CTM/IND/NDA programs in a cGMP environment. You will collaborate with QA, QC, Regulatory Affairs and Strategic Clinical Development to meet critical project timelines.

You will review batch records, release and stability data, develop and revise SOPs, and participate in development reports, CAPAs, and investigations with a focus on data interpretation and compliance.

Qualifications

• Bachelor’s degree in science/engineering with 5+ years in pharma cGMP
• Master’s degree in science/engineering with 3+ years in pharma cGMP
• Ability to work independently and in a team under deadlines
• Experience in review of batch records
• Ability to interpret technical data relative to GMP requirements
• Proficient with Microsoft Office and Adobe Acrobat
• Knowledge of Trackwise, MasterControl, Veeva Vault and SAP

Responsibilities

• Review and disposition of batch records and related documentation for CTM/IND/NDA batches
• Review quality control final product, release and stability data
• Coordinate with QA, QC, Regulatory Affairs and other departments on QA tasks
• Support CAPAs and change controls to maintain cGMP
• Create and revise SOPs and work instructions
• Participate in CMC development activities as they relate to QA
• Independently interpret data to resolve complex quality issues
• Review development and validation reports and other technical records

Skills

Batch records review

cGMP compliance

Data interpretation

Communication

Microsoft Office

GxP systems

Education

Bachelor’s degree in science/engineering

Master’s degree in science/engineering

Tools

Trackwise

MasterControl

Veeva Vault

SAP

Job description

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.

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

• medical / dental / vision / prescription coverage
• employee wellness resources
• savings plans (401k and ESPP)
• paid time off & paid parental leave benefits
• disability benefits
• and more

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.