Manager, QA

Job Summary

Responsible for oversight of all quality aspects related to manufacture of commercial & clinical products at contract manufacturing organizations (CMOs). In partnership with QC, Regulatory Affairs, Contract Manufacturing and Project Management the QA Manager will ensure that products are manufactured in accordance with cGMPs, regulatory commitments, Assertio requirements and internal procedures.

Essential Job Functions

• 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.

Additional Responsibilities/Duties

• 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%

Education and Experience

• 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.
• 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 Quality Management Systems (Trackwise, Veeva, etc.) is required
• Experience with combination products a bonus

Skills and Abilities

• 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