Bachelor's degree or equivalent experience in related field required
Minimum 7 years' experience in GMP environment, including 5 years in QA
Experience with manufacturing commercial pharmaceutical products required
Prior experience with outsourced GMP activity and clinical experience strongly desired
Familiarity with Quality Management Systems (e.g., Trackwise, Veeva) is essential
Responsibilities
Approve master batch records and specifications
Release or reject commercial product batches
Provide regulatory guidance in line with 21 CFR 211
Approve deviations with a focus on root cause analysis
Audit CMOs, test laboratories and raw material suppliers
Manage product complaints according to established procedures
Establish or optimize quality systems for efficiency
Benefits
Inclusive work culture that values diversity
Support for applicants needing reasonable accommodations
Continuous learning and development opportunities
Full Job Description
Overview
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
Physical/Mental Demands
Sitting - 80%
Standing/ walking - 20%
Must be able to enter clean room environments and manufacturing areas, and to follow gowning procedures.
Lifting: Raising objects under 40 pounds from a lower to a higher position or moving objects horizontally
Repetitive motion: Substantial movements of the wrists, hands, and/or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
Visual Requirements: Able to see and read PC screens and read fine print.
Collaboration: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
Decision Making: Ability to make decisions which have impact on the department/company credibility, operations, and services.
Communication: Ability to compose letters, outlines, memos and basic reports, and to orally communicate technical information and to complete forms, use existing form letters and conduct routine oral communication.
Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes.
Comprehension: Ability to understand, remember, and apply oral and/or written instructions or other information. Ability to understand, remember and communicate routine, factual information and to organize thoughts/ideas into understandable terminology.
About Assertio
Assertio is a pharmaceutical company that develops and markets drugs for the treatment of pain and other central nervous system disorders. The company's products include Gralise, a treatment for postherpetic neuralgia, and Zipsor, a nonsteroidal anti-inflammatory drug. Assertio was founded in 1995 and is headquartered in Lake Forest, Illinois.
