Pelthos - Quality Assurance Manager

2 weeks ago

Durham, United States Ligand Pharmaceuticals Full time
Job DescriptionJob Description

As a key member of the Quality Assurance team, the Pelthos Quality Assurance Manager is responsible for the implementation and maintenance of all aspects of the Pelthos Quality Management System in support of internal and outsourced GCP, GLP, and GMP activities.

Essentials for Working at Pelthos and Ligand

  • Pelthos is a dynamic, fast-paced organization committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. ZELSUVMI™ (berdazimer) topical gel, 10.3% for the treatment of molluscum contagiosum is now approved by the U.S. Food and Drug Administration. To be successful at Pelthos, employees must be innovative, efficient, versatile, self-starters who take great pride in their work and want to contribute to something significant. As of the posting date, Pelthos is a subsidiary of Ligand Pharmaceuticals.

Key Job Responsibilities

  • Manage and be an active participant in raw material release activities, document management, training, quality agreements, change controls, batch disposition process, internal and external production, all analytical testing at CDMOs/CMOs, deviations, OOSs, CAPAs and investigations
  • Manage the Pelthos Electronic Document Management System (EDMS) and associated electronic and hard paper archives, along with company's employee training program
  • Issue to applicable functional areas then track and receive back all logbooks, lab notebooks, protocols, and batch records
  • Provide independent oversight and compliant direction with authority for CMC Quality and product disposition, including CDMOs and CMOs
  • Plan, schedule, conduct, report and close internal/contracted cGMP audit activities ensuring compliance to internal audit/supplier management requirements
  • Assist in creating and responsible for implementing a system for tracking quality metrics as they relate to Pelthos operations and the equivalent activities with the delegated scopes work with Pelthos' vendors. Responsible for reporting metrics to Pelthos management team on a routine basis
  • Approve Protocols and Reports, Master Batch Records and Executed Batch Records.
  • Review and verify process data to ensure compliance with data integrity and appropriate regulatory requirements
  • Ensure ongoing regulatory inspection readiness to meet Pelthos regulatory applications and cGMP requirements based on FDA rules and regulations
  • Responsible for developing and implementing efficiencies within the QMS
  • Provide support to the overall manufacturing process including with production discrepancies
  • Perform internal audits as required
  • Assist with regulatory audits as necessary


  • BS/BA in life sciences, engineering, or a related discipline is required (MS/MA a plus)
  • 5-8 years of experience in direct quality assurance or equivalent roles in the pharmaceutical industry
  • Management of the electronic document management systems
  • Experience with MasterControl preferred
  • Management of Regulatory Agency inspection activities
  • Management of global based projects
  • Experience leading teams preferred

Benefits

The company offers competitive benefits including medical, dental, vision, short/Long term disability and life insurance, as well as 401(k) match, stock options, bonus, and paid time leave.

Salary, dependent on experience

Additional Information

  • All new hires are required to go through a background and reference check
  • Pelthos / Ligand is an EEO/AA/Disability/Vets employer
  • Must be legally authorized to work in the US without sponsorship
  • Pelthos / Ligand celebrates the diversity of life and welcomes all individuals to apply


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