Sr. Specialist, Quality OUS

About Currax

Currax Pharmaceuticals, LLC is a specialty pharmaceuticals company focused on providing increased access to life-changing medications for patients and healthcare providers. We seek to improve patient health and quality of life through the acquisition and commercialization of medications, including Contrave, the number one branded oral anti-obesity medication in the U.S.

At Currax, we take pride in our mission to serve patients, and we value authenticity and collaboration in our workplace. As we experience an exciting period of accelerated growth, our organization is rich with opportunities for our people to gain hands-on experience and fulfill career aspirations while making a direct impact on the lives of patients we serve.

The Sr. Specialist, Quality OUS reports to the Director, Quality and is primarily responsible for supporting the development and maintenance of the Currax Pharmaceutical Quality System. Additionally, this role will manage and oversee critical quality system elements pertained to supplier management, product dispositions, deviations, change control, CAPA and support Quality Management Review.

• Support the day-to-day quality systems for Currax products.
• Provide Quality oversight of clinical, commercial, distribution, and drug safety/pharmacovigilance activities.
• Oversee Document Control, Deviations, CAPA, Change Control, Complaints, Training and Metrics.
• Partner with Supply Chain, Regulatory Affairs, Tech Services and Management to ensure compliance with Currax policies, procedures, and industry regulations.
• Provide Contract Manufacturing Organization (CMO) Quality Oversight.
• Evaluate/approve product quality complaint investigations and associated CAPA(s).
• Log and facilitate third-party supplier/CMO investigations.
• Facilitate the Document Control System.
• Support the administration of Currax s eQMS system.
• Facilitate the third-party change control system.
• Support internal and external audits as needed.
• Assist as needed in the drafting of Quality Agreements.
• Participate in internal and external meetings and site visits to ensure cGxP compliance.
• Build relationships with Quality partners at CMOs to resolve quality issues in a timely manner.
• Compile and provide documentation and responses to Regulatory and Compliance requests (GMP renewals, RA questions and submissions, observations, compliance gaps, audits).
• Compile Annual Product Quality Reviews.
• Engage in activities to continuously assess and improve processes.
• Support the assessment, implementation, and management of Currax s Risk Management Program.
• Support the Supplier Qualification program including, but not limited to, maintaining the Approved Supplier List in state of compliance, schedule, assign and conducts external audits, including issuing of audit reports and conducting follow-ups as appropriate.
• Other duties as required or directed by QA Management.

• Bachelor s degree in a scientific discipline.
• 5 - 7+ years of progressive experience in a QA / Compliance GMP environment.
• Experience as a DRP/RP preferred (not required).
• Working knowledge of GMPs and their application to pharmaceutical manufacturing.
• Previous exposure to investigations and product complaints preferred.
• Must be able to interpret applicable standards and objectively make decisions with support of management.
• Experience with the application of GDPs within the pharmaceutical industry.
• Familiarity with the manufacturing and packaging process of solid oral dosage and liquid drug products; pharmaceutical cGMP auditing experience.
• Experience working with external partners in a Quality Assurance capacity.
• Must be proficient in MS Office Suite.
• Excellent organizational and communication (oral and written) skills.
• High level of flexibility and willingness to learn.
• Ability to work in a high paced, timeline driven corporate office setting.

• Integrity
• Passion
• Accountability
• Commitment
• Teamwork