Manager Quality Assurance

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 provide leadership, direction, strategy, and execution of Quality Assurance activities including but not limited to ensuring that products are developed in compliance with established standards and laws, participating in the review and approval of all procedures and specifications impacting products, and managing Quality Assurance audits.

Essential Duties & Responsibilities:

• Ensure that products are manufactured in compliance with all appropriate laws, regulations, and guidance and in accordance with applicable regulatory filings in close partnership with internal and 3rd party suppliers.
• Lead a team of QA associates and oversee the batch release process, ensuring products meet all cGMP requirements.
• Support regulatory processes associated with commercial products.
• Provide support for Pharmacovigilance processes including customer complaint handling.
• Investigate any non-conformances related to product quality and/or adverse quality.
• Participate in the review and approval of all procedures and specifications impacting the quality of drug products.
• Initiate and/or revise Quality Assurance processes in accordance with U.S. regulations and internal standards to ensure the quality of the regulated activities at Supernus.
• Provides training to junior personnel related to the review of Quality Assurance procedures such as External Change Controls, Deviations and Out of Specification Investigations.
• Maintain the Quality management systems in accordance with U.S. regulations and internal standards.
• Manage departmental training including generation, review, and approval of training plans, delivery of hands-on training as needed.
• Lead and/or support continuous improvement initiatives.
• Identify/Improve Quality Metrics and Key Performance Indicators for monthly evaluation.
• Maintain positive relationships with CMO representatives to promote alignment on quality, safety and efficacy of products.
• Review Standard Operating Procedures on behalf of QA.
• Revise existing Standard Operating Procedures as needed.
• Stays current with CFR and FDA guidance documents to ensure that Supernus' compliance policies are up to date.
• Participate in project meetings to provide the QA perspective as needed.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Participate in internal audits or external audits as needed.
• Participate in FDA inspections regarding Supernus regulated activities.
• Participate in Internal Audits of QA.
• Some travel may be required.

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.

Knowledge & Other Qualifications:

• BS degree or higher in a computer science or other science-related discipline.
• 5+ years of practical related experience.
• 2+ years of leadership/supervisory experience.
• Experience with the manufacture and distribution of marketed drug products is required.
• Experience with GMPs is required.
• Experience with investigative techniques, and root cause analysis is required.
• Experience with a Quality Management system is preferred.
• Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel.
• Knowledge of Good Documentation Practices and ALCOA+.
• Knowledge of FDA GMP Regulations.
• Strong communication and technical writing skills in English language.
• Ability to work in a fast paced and flexible work environment where priorities can change.
• Strong Analytical, decision making, interpersonal, and mentoring skills.
• Track record of building effective internal and external partnerships.
• Creative problem solver and keen ability to address current and anticipated issues.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have 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:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• 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 $115,000 to $130,000. 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.