Senior GxP Quality & Compliance Auditor

Supernus Pharmaceuticals Inc; Rockville (MD); On-site; USD 90,000 - 108,000; Full time

Job summary

Supernus Pharmaceuticals is seeking a Quality Assurance professional to perform QA activities ensuring CFR/JCGP compliance for clinical and manufacturing operations. The role involves audits, CAPA, change controls, and supplier oversight across CMOs and labs.

The ideal candidate has a life sciences degree and 4+ years in GMP/GCP environments, with strong writing and communication skills and proficiency with validation concepts and MS Office.

Qualifications

• B.S. in a life sciences discipline.
• Minimum of 4+ years of experience in GMP and/or GCP environment.
• Comprehensive understanding of GMPs, GCPs, and GLPs and their application to a wide variety of problems and situations.
• Proficiency in Microsoft Office Suite.
• Strong communication and technical writing skills.
• Ability to work independently, as well as ability to function as a team player, ability to accept personal accountability for successful job performance, and ability to initiate and offer suggestions aimed at improving service to our customers.
• Familiar with pharmaceutical equipment, utilities, and validation concepts.
• Ability to be flexible and to work efficiently and accurately to meet set goals and timelines.

Responsibilities

• May manage and perform internal and external GxP audits, GCP and GLP audits, investigation site audits and internal bioanalytical audits as directed by management.
• May provide oversight of suppliers (CMOs, distributors, laboratories, GMP service providers, GLP and GCP vendors etc.) as directed by management.
• Reviews and approves internal and external deviations, investigations, OOS, CAPA, and change controls.
• Reviews documentation related to GCP and GLPs.
• Reviews GxP records (e.g., process validation, equipment qualification, software validation) for compliance with FDA regulations, internal company standards, and others as applicable.
• May review analytical method validation protocols, technical reports, stability protocols and respective reports.
• May review and approve clinical and bioanalytical protocols and reports.
• Revises and maintains the QA compliance systems in accordance with U.S. regulations and internal standards to ensure the quality of clinical trial material being produced.
• Initiates new or revises existing SOPs for corporate QA as needed. Reviews SOPs from a compliance point of view.
• Stays current with changes, amendments to the CFR and/or FDA guidance documents to ensure that Supernus’ compliance policies and procedures are up to date.
• Assists in all regulatory agencies’ inspections regarding Supernus products.
• Assists QA in product release, when needed.
• Occasionally participates in project meetings, company task force, and compliance initiative teams, to provide the QA perspective and technical support as needed.
• Other duties as assigned.

Skills

GMP/GCP experience

GLP knowledge

Microsoft Office

Technical writing

Communication

Independent worker

Team player

Pharma equipment familiarity

Flexibility

Life sciences background

Education

B.S. in life sciences

Tools

GxP auditing tools

Job description

Supernus Pharmaceuticals is seeking a Quality Assurance professional to perform QA activities ensuring CFR/JCGP compliance for clinical and manufacturing operations. The role involves audits, CAPA, change controls, and supplier oversight across CMOs and labs.

The ideal candidate has a life sciences degree and 4+ years in GMP/GCP environments, with strong writing and communication skills and proficiency with validation concepts and MS Office.