Assertio · 3 months ago
Manager, QA
Lake Forest, IL
Full-time
Onsite
Senior Level
7+ years expAssertio is a company focused on the manufacture of commercial and clinical products. The QA Manager will oversee all quality aspects related to manufacturing at contract manufacturing organizations, ensuring compliance with regulations and internal procedures.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedicalPharmaceutical
Responsibilities
Approve master batch records, specifications, qualification & validation protocols and reports, labels, stability protocols and reports
Approve/release (or reject) commercial batches
Provide guidance and make recommendations regarding issues that relate to manufacturing products in accordance with 21 CFR 211, other applicable regulations and current industry standards
Approve deviations, ensuring that root cause analysis and corrective actions are adequate
Audit CMOs, contract test laboratories and/or raw material suppliers
Manage product complaints according to procedure
Establish or optimize quality systems
Perform risk analysis to assess inadvertent events that may impact product identity, strength, quality, purity
Advise and/or manage risk management strategies
Author quality agreements and standard operating procedures
Must be capable of working independently with minimum supervision
Represent quality management at CMOS
Establish/maintain effective working relationship with CMOs/business partners
Partner with ‘CMC’ team members to ensure a cohesive unit aligned in expectations for CMO deliverables
Travel estimated 25%
Qualification
Required
Bachelor's degree or equivalent experience in related field required
Minimum 7 years' experience in GMP environment with at least 5 years QA experience
Experience with manufacturing commercial pharmaceutical products is required
Experience with Quality Management Systems (Trackwise, Veeva, etc.) is required
Must be capable of working independently with minimum supervision
Strong oral and written communication skills
Ability to recognize and accommodate cultural differences in a work environment
Ability to multitask and prioritize own work schedule
Computer literate (word, excel, powerpoint, etc.)
Good collaborative skills
Skilled in risk analysis/risk management strategies
Preferred
Prior experience with outsourced GMP activity and clinical experience strongly desired
Experience with method development and method validations in a QC chemistry and microbiology cGMP Manufacturing environment is desired
Experience with combination products a bonus
Company
Assertio
Assertio is a pharmaceutical company focused on developing and commercializing products to treat pain and other.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.01B2022-08-22Post Ipo Equity· $60M
2021-02-10Post Ipo Equity· $34.3M
2021-02-05Post Ipo Equity· $14M
Leadership Team
Mark Reisenauer
Chief Executive Officer
Recent News
2026-01-11
2025-11-11
2025-11-11
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