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:- 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.
Supervisory Responsibilities:Knowledge & Other 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.
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.
Compensation:At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $90,000 to $108,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
