Job summary
Job post source
This job is directly from Supernus Pharmaceuticals, Inc.
Job overview
The Manager Quality Compliance at Supernus Pharmaceuticals leads quality assurance and GxP compliance activities to ensure regulatory adherence and improve product quality impacting CNS disease treatments.
Responsibilities and impact
The role involves leading internal and external audits, managing supplier assessments, overseeing quality programs like APR and DRB, ensuring document compliance with GxP standards, preparing for regulatory inspections, monitoring quality metrics, supervising staff, and supporting various GxP initiatives.
Compensation and benefits
The position offers a competitive salary range of $100,000 to $125,000, with additional benefits including employee stock purchase programs and performance-based bonuses.
Experience and skills
Candidates should have a B.S. in life sciences or engineering, 5+ years in a GMP environment, 2+ years supervisory experience preferred, supplier management and auditing experience, knowledge of GMP, GLP, GCP regulations, proficiency in Microsoft Office, strong communication and problem-solving skills, and familiarity with pharmaceutical equipment and validation processes.
Career development
The role includes opportunities for staff coaching, mentoring, and career development through leadership and performance evaluations.
Work environment and culture
Supernus Pharmaceuticals values integrity, innovation, teamwork, and ethical standards, fostering a supportive environment aligned with company values.
Company information
Supernus Pharmaceuticals is an award-winning biopharmaceutical company with over 30 years of experience developing CNS disease treatments, currently marketing 8 impactful products.
Job location and travel
The position requires travel up to 25% and involves physical activities such as prolonged sitting, standing, and lifting up to 20 pounds, with no significant adverse environmental exposure.
Unique job features
The job features leadership in quality compliance within a biopharmaceutical context, involvement in regulatory inspections, and management of comprehensive quality programs ensuring adherence to evolving regulations.
Company overview
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The company generates revenue through the sale of its proprietary medications, which include treatments for epilepsy, migraine, and Parkinson's disease, among others. Founded in 2005, Supernus has a history of leveraging its expertise in drug formulation and development to bring innovative therapies to market. The company is committed to addressing unmet medical needs and improving the lives of patients with CNS disorders through its robust pipeline of product candidates and strategic acquisitions.
How to land this job
Position your resume to emphasize your leadership in quality assurance systems, GxP compliance, and supplier management, highlighting your experience with audits, inspections, and document control in regulated environments like pharmaceuticals.
Focus on showcasing your ability to lead internal and external audits, manage compliance programs, author controlled documents such as SOPs and policies, and your experience with regulatory requirements including GMP, GLP, and GCP.
Apply through multiple platforms, including Supernus Pharmaceuticals' official corporate careers page and LinkedIn, to maximize your application visibility and increase chances of being noticed.
Connect with current employees in the Quality Compliance or Regulatory Affairs divisions at Supernus Pharmaceuticals on LinkedIn; use ice breakers such as commenting on recent company product launches or asking about their experience with the internal audit program or supplier management initiatives.
Optimize your resume for ATS by incorporating keywords from the job description like 'GxP compliance,' 'internal audits,' 'supplier management,' 'document control,' 'regulatory inspections,' and 'quality metrics' to ensure it passes initial screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored resume submissions, find multiple application portals, and identify key LinkedIn contacts to network with, allowing you to focus your time on interview preparation and skill enhancement.
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