Manager, QA

Assertio Therapeutics•Lake Forest, IL

About The Position

The Manager, QA is responsible for oversight of quality aspects related to the manufacture of commercial and clinical products at contract manufacturing organizations (CMOs). In partnership with QC, Regulatory Affairs, Contract Manufacturing, and Project Management, the role ensures products are manufactured in accordance with cGMPs, regulatory commitments, Assertio requirements, and internal procedures. The position requires independent work with minimal supervision and representation of quality management at CMOs. Travel is estimated at 25%.

Requirements

Bachelor’s degree or equivalent experience in a related field.
At least 7 years of experience in a GMP environment, including at least 5 years of QA experience.
Experience manufacturing commercial pharmaceutical products.
Experience with Quality Management Systems such as Trackwise or Veeva.
Strong oral and written communication skills.
Ability to recognize and accommodate cultural differences in a work environment.
Ability to multitask and prioritize one's own work schedule.
Computer literacy, including Word, Excel, and PowerPoint.
Good collaborative skills.
Skill in risk analysis and risk management strategies.
Ability to work independently with minimal supervision.
Ability to enter clean room environments and manufacturing areas and follow gowning procedures.

Nice To Haves

Prior experience with outsourced GMP activity.
Clinical experience.
Experience with method development and method validations in a QC chemistry and microbiology cGMP manufacturing environment.
Experience with combination products.

Responsibilities

Approve master batch records, specifications, qualification and validation protocols and reports, labels, and stability protocols and reports.
Approve and release, or reject, commercial batches.
Provide guidance and recommendations on manufacturing products in accordance with 21 CFR 211, other applicable regulations, and current industry standards.
Approve deviations and ensure root cause analyses 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 affect product identity, strength, quality, or purity.
Advise on and/or manage risk management strategies.
Author quality agreements and standard operating procedures.
Represent quality management at CMOs.
Establish and maintain effective working relationships with CMOs and business partners.
Partner with CMC team members to align expectations for CMO deliverables.