Manager Quality Compliance

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. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary:

To perform quality assurance systems and GXP activities; to coordinate and supervise the supplier management, audit, inspection, and document management activities, including, but not limited to, maintaining the compliance systems in accordance with U.S. regulations and standards and internal Supernus procedures.

Essential Duties & Responsibilities:

• Leads the internal audit program including performing final review of audit findings and responses.
• Leads internal and external audits of the various quality elements to ensure compliance to GxP regulatory commitments and requirements, industry best practices and guidance.
• Supports the supplier management program including performing final review / assessments of suppliers.
• Plans, directs, and coordinates implementation of Quality/Compliance program activities including the creation/ revision of controlled documents (e.g., SOPs, policies) in accordance with GxP regulations and internal standards.
• Oversees the Annual Product Review (APR) program including authoring of APRs for each product line.
• Oversees the Deviation Review Board (DRB) program including communication of metrics and program performance concerns to Senior Management.
• Works with Supernus personnel to design and implement programs to improve overall quality and increase regulatory compliance.
• Ensures GxP documents (SOPs, deviations, changes, validation reports, etc.) are reviewed for completeness, accuracy, and conformance to GXPs.
• Participates in company preparations for regulatory inspections, which may include reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management of program inspection quality events.
• Supports and participates in inspections of Supernus by regulatory agencies and in audits by third parties.
• Monitors changes and amendments to the applicable regulations (e.g., CFR, ISO standards for devices, FDA guidance documents, EU GMPs) to ensure that Supernus' procedures are compliant and current.
• Monitors and trends key quality and compliance metrics for Supernus and suppliers; reports adverse trends to management with remediation plan.
• Assists in preparation and execution of management review.
• Assist in identifying and resolving compliance issues at internal and external sites; provide assessment of the impact of any deficiencies.
• Supervises, trains and mentors staff to perform quality functions consistent with GxP requirements.
• Participates in project meetings and compliance initiative teams, to provide the compliance/quality perspective and technical support as needed.
• Ensures that the appropriate validations are enacted on time and documented.
• Supports other GxP activities and initiatives, as required.

Non-Essential Duties & Responsibilities:

• N/A

Supervisory Responsibilities:

• Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives.
• Understands Company Policy and procedure to be able to guide direct reports appropriately.
• Ensure staff is appropriately coached and mentored for continued growth and career development.
• Perform employee performance reviews and evaluate annual employee goals.

Knowledge & Other Qualifications:

• B.S. in a life sciences or engineering discipline.
• 5+ years of experience in GMP environment.
• 2+ years of direct supervisory experience preferred.
• Previous supplier management and auditing experience in a GxP environment required.
• Knowledge of GMP, GLP, and GCP regulations and their application to a wide variety of problems and situations.
• Proficient in Microsoft Office Suite.
• Strong communication and technical writing skills.
• Systematic problem-solving skills to solve complex issues with minimal input from senior staff.
• Ability to work independently, to function as a team player, to accept personal accountability for successful job performance, and 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.
• Familiar with software systems and validation processes.

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 (up to 25%).
• Position may requires 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 $100,000 to $125,000. 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.

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.