Senior Quality Compliance Associate

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

To perform various quality assurance activities including but not limited to maintaining the compliance systems in accordance with U.S. and internal regulations and standards.

• 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.

• N/A

• 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.

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

• Travel is required (approximately 25%).
• Position may require prolonged sitting, prolonged…