SUMMARY OF POSITION

The Quality Manager is a member of the US Quality department. In this position, the QA Manager will have oversight and hands on management of:

• Hands on management of release testing and stability programs for complex sterile products – US and ROW
• Tracking all testing, results for release, investigating shipping temperature excursions, manage and approve protocols for new stability programs, monitor ongoing stability programs, laboratory OOS/deviations, and managing change controls ensuring adherence to regulatory applications and Alvogen’s Quality Management System
• Batch record review and batch release of product

The position will require strong scientific background for oversight of laboratory testing of a biological product. In addition, in depth knowledge of Quality Systems including activities such as stability programs, method transfer, troubleshooting/investigation support for OOS/OOT, change control, batch record review and product release. This position requires reporting of associated KPI’s. This person will interact with internal and external business partners, contract manufacturers and contract laboratories. The individual serves as a critical link to Alvogen’s external partners to ensure timely release testing for release and real time stability monitoring. Being able to multi-task multiple products and effectively communicate and transmit information to/from the partners is essential to ensure compliance and optimal performance.

ORGANIZATION STRUCTURE

The QA Manager reports directly to the Director, Third Party Quality, Sterile Products and Medical Devices. There are no reports, direct or otherwise to the QRM.

RESPONSIBILITIES

Primary responsibilities of this role include, but are not limited to, the following:

• Release and Stability Program Oversight
• Manage all testing and reporting for release and stability results from multiple testing laboratories
• Complex deviation handling (review and approval) of temp excursions, OOT, OOS and laboratory investigations – trouble shooting skills necessary. Work closely with contract laboratories throughout investigation process (Phase I and Phase II) to closure
• Review and approve complex lab deviations in collaboration with the Alvogen analytical support staff, ensuring proper impact assessment to product.
• Oversee new stability protocol review and approvals
• Test method change controls
• Support method transfer / technical transfer / validation activities with external business partners / CMOs.
• Documentation Review & Approval:
• Review and approve documentation such as Test Methods, Manufacturing Records, SOPs, Investigations, Change Controls, Validation Protocols and Reports, Equipment Qualifications and similar documents as directed by Quality Management.
• Perform Commercial Finished Product / Bulk Drug Product Release:
• Execute the Alvogen Inc. and Almatica Pharma Inc. material release procedure(s). Manage commercial release priorities per business deadlines. Work directly with manufacturers and partners to resolve related questions/issues.
• File, retrieve, and maintain organized records
• Communicate with external business partners / CMOs regarding quality related issues and Quality Agreements.
• Track metrics for external business partners / CMOs on change controls, deviations, repeat deviations, product releases and rejections and other Third-Party Quality Key Performance Indicators.
• Review Annual Product Reports / Product Quality Reports.
• Change Management Program:
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QUALIFICATIONS

Position requires the following education and qualification prerequisites:

1. BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 10 years’ experience in the Pharmaceutical Industry working with Quality Control biological and chemical testing, sterile and medical device products, with a minimum of five years in a quality organization. Other degrees will be considered based on extensive industry experience.
2. Strong experience in GxP laboratory practices, ability to review and assess data, especially from a Quality R&D perspective.
3. Experience with various complex biological and chemical test methods
4. Experience in troubleshooting and conducting investigations.
5. Release of materials and products supporting both development and commercial activities.
6. Has knowledge of GxP quality systems, US FDA regulations and ICH guidance documents. Experience with EU requirements a plus.
7. Must hold strong interpersonal and communication skills. Must have the ability to work well with diverse groups including the ability to work in a team environment. Must also display strong organizational skills with the ability to lead team meetings and to manage multiple projects at one time.
8. Strong technical writing and computer skills also required.
9. Must display the ability to work independently with little or no supervision and plan and accomplish set goals.

Physical Demand Factors

1. While performing the duties of this job, the QM is required to sit and work at a computer for extended periods of time.
2. Is regularly required to talk, listen, and attend meetings / teleconference calls.
3. Approximately 20% business travel required to external Contract Manufacturing Organization (CMO) / Business Partner sites, or to attend professional development training seminars – as needed / directed.

GMP DECISION-MAKING AUTHORITY

Independent decision-making activities will be performed by the QA Manager for all the quality management system elements outlined in the Responsibilities section of this Job Description.