Senior Quality Compliance Associate

Senior Quality Compliance Associate Supernus Pharmaceuticals Quality Assurance Job Summary: 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. Essential Duties & Responsibilities: Manages and performs internal and external GxP audits. Provides oversight of suppliers (CMOs, distributors, laboratories, GMP service providers, etc.) 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. Reviews analytical method validation protocols, technical reports, stability protocols and respective 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. Supervisory Responsibilities: N/A Knowledge & Other Qualifications: B.S. in a life sciences discipline. Minimum of 4+ years of experience in GMP 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. Other Characteristics: 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. Physical Requirements/Work Environment/Travel Requirements: Travel is required (approximately 25%). Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; the ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading The worker is not substantially exposed to adverse environmental conditions Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees we be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an “at-will” basis. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.