What are the responsibilities and job description for the Manager, QA position at Assertio Therapeutics?
Overview:
Physical/Mental Demands
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Responsible for oversight of all quality aspects related to manufacture of commercial & clinical products at third party service providers (CMOs, CDMOs, test labs). In partnership with Regulatory Affairs, Technical Operations Staff, and Alliance Management the QA Manager will ensure that products are manufactured in accordance with cGMPS, regulatory guidelines, Assertio requirements and internal procedures.
Responsibilities:
Essential Job Functions
- Serve as the operational QA interface with all external service providers and vendors.
- Approve master batch records, specifications, qualification & validation protocols and reports,stability protocols and reports.
- Disposition commercial of batches.
- Provide guidance and make recommendations regarding issues that relate to manufacturing products in accordance with 21 CFR 211, ICH, other applicable regulations and current industry standards.
- Approve deviations, ensuring that root cause analysis and corrective actions are adequate.
- Assist in audits of vendors and contract service providers (manufacturers, test laboratories, raw material suppliers) as part of vendor management program.
- 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.
- Perform quality assessments as part of business development due diligence.
- Author quality agreements and standard operating procedures.
- Must be capable of working independently with minimum supervision.
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 external vendor/service provider deliverables.
- Travel estimated 25%
Education and Experience
- Bachelor’s degree
- Minimum 5 years’ experience in GMP environment with at least 3-5 years QA experience
- Experience with manufacturing commercial pharmaceutical products is required.
- Prior experience with outsourced GMP activity strongly desired
- Experience with combination products a bonus
- Preferred experience with Trackwise Digital
Skills and Abilities
- Strong oral and written communication skills
- Ability to recognize and accommodate cultural differences in a work environment.
- Ability to multitask.
- Computer literate (Word, Excel, Powerpoint, etc.)
- Good collaborative skills
- Skilled in risk analysis/risk management strategies
Physical/Mental Demands
- Sitting – 80%
- Standing/ walking - 20%
- Travel 25%, domestic and international.
- Must be able to enter clean room environments and manufacturing areas, and to follow gowning procedures.
- 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.
- Comprehension: 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 formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications of major scope and impact, etc. and to make formal presentations.
- Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes.
Accommodations for Applicants with Disabilities
Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.
For more information about your EEO rights as an applicant under the law, please click here.