JOB DESCRIPTION:

This position supports quality activities within Commercial Quality, including compliance with controlled substance regulations, complaint handling, change control, documentation, and audit coordination. The role requires adherence to environmental policies and contribution to departmental environmental objectives.

Responsibilities:

• Customer Applications (50%): Process Know Your Customer (KYC) applications for SPRAVATO® purchases.
• Data Analysis (10%): Conduct routine data analysis for Suspicious Order Monitoring.
• Product Quality Complaints (10%): Handle PQCs in the quality system, including evaluations, investigations, summaries, and workflow management.
• Quality Events & Change Control (10%): Manage records in Track Wise/COMET.
• Documentation (10%): Coordinate documents/procedures in true Vault or equivalent systems.
• Audits (10%): Coordinate internal/supplier audits—logistics, planning, execution, CAPA coordination, and documentation in Track Wise.
• Support enterprise-wide and global business quality and compliance initiatives.

Requirements:

• BA/BS in Technical or Life Sciences.
• MA/MS/MBA in Business, Technical, or Life Sciences.
• 5 years in the pharmaceutical or related industry.
• Strong knowledge of GMP/GDP and DEA regulations.
• Experience within quality organizations.
• Familiarity with regulatory inspection expectations.
• Proficiency in Track Wise/COMET, data reporting, and Excel.
• Strong leadership with a results-oriented mindset.
• Ability to collaborate across departments like IT, Manufacturing, Regulatory, and Commercial.
• Experience in managing audits, documentation, and quality events.
• Credo Values.
• Innovation.
• Mastering Complexity.
• Customer/Marketplace Focus.
• Independent Partnering.

• Customer Applications (50%): Process Know Your Customer (KYC) applications for SPRAVATO® purchases.
• Data Analysis (10%): Conduct routine data analysis for Suspicious Order Monitoring.
• Product Quality Complaints (10%): Handle PQCs in the quality system, including evaluations, investigations, summaries, and workflow management.
• Quality Events & Change Control (10%): Manage records in Track Wise/COMET.
• Documentation (10%): Coordinate documents/procedures in true Vault or equivalent systems.
• Audits (10%): Coordinate internal/supplier audits—logistics, planning, execution, CAPA coordination, and documentation in Track Wise.
• Support enterprise-wide and global business quality and compliance initiatives