Quality Relationship Manager, QA Tech Service

Norwich Pharmaceuticals Inc • Morristown, NJ

6d • $100,000 - $135,000

About The Position

The QRM (Quality Relationship Manager) Technical Services is a member of the US Quality department. In this position, the QRM will be interacting primarily with Alvogen’s external business partners/CMOs. The incumbent will have responsibility for mainly managing products from development to product launch and commercial phase as assigned. QRM is responsible for supporting the technical aspects of the products as well as the adherence to Alvogen’s Quality Management System. The position will require in depth knowledge of Quality Systems including activities such as development, validation, troubleshooting/ investigation support, complaint handling, change control, product release, inspection support, etc. The individual will also support the technical transfer of products to/from various CMO’s. The individual serves as a critical link to Alvogen’s external partners. Being able to effectively communicate and transmit information to/from partners is essential to ensure compliance and optimal performance.

Requirements

• Good leadership skills in all areas of communication, influencing, collaboration and decision-making.
• BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 10 years’ experience in the Pharmaceutical Industry preferred. Other degrees will be considered based on extensive industry experience.
• Experience in GxP laboratory practices.
• Release of materials and products supporting both development and commercial activities.
• Has knowledge of GxP quality systems, US FDA regulations and ICH guidance documents.
• Experience with various manufacturing / filling processes associated with ‘non-sterile’ drug products.
• Demonstrated experience supporting deviations, investigations especially, OOS investigations. Experience in conducting, writing/reviewing deviations and investigations, root cause analyses, and identifying corrective actions. Must have strong technical knowledge of FDA and other regulatory guidance and be able to critically review complex investigations, interpret results and able to evaluate technical input against compliance requirements in line with CFR requirements and other regulatory requirements and Alvogen procedures/policies.
• 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.
• Strong technical writing and computer skills are also required.
• Must display the ability to work independently with little or no supervision and plan and accomplish set goals.

Responsibilities

• Documentation Review & Approval: Review and approve documentation such as Method Validations, Manufacturing Records, SOPs, Investigations, Change Controls, Validation Reports, Technical reports required for regulatory filing, including but not limited to Extractables/ Leachable studies, Nitrosamine Reports etc, Equipment Qualifications and similar documents as directed by Quality Management.
• Inspections and Audits: Prepare / Support preparation activities for regulatory inspections Evaluate regulatory agency findings from inspections conducted at CMOs/CPOs/analytical Laboratories, etc.
• Support the design and implementation of system / process improvements where opportunities are identified (Commercial & Development), including associated CAPA’s.
• Support technical transfer / validation activities with external business partners / CMOs.
• Manage the Finished Product / Bulk Drug Product ANDA/NDA, Launch Release System: Execute the Alvogen Inc. and Almatica Pharma Inc. material release procedure(s). Manage ANDA/NDA, launch release priorities per business deadlines. Work directly with CMOs 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.
• Provide investigation/trouble-shooting support as needed. Review and approve investigations, unexplained discrepancies, failures, and out-of-specification results. Evaluate if there is any quality impact to process/product and take appropriate action.
• Track metrics for external business partners / CMOs on change controls, deviations, complaints, audits, product releases and rejections and other Third-Party Quality Key Performance Indicators.
• Change Management Program: Process change controls for all systems requiring change control support (e.g. specifications for raw materials, drug product intermediates and finished drug products, validation protocols and reports, master production and packaging records, cleaning records, and analytical methods. Maintain change control electronic records in EQMS. Review, assess, and approve change controls as required by SOP’s. Support training of company personnel on change control system.
• Support the corporate Training Program, when / if needed.
• Support the corporate audit program as needed / required.
• Keeps abreast of industry regulations and cGMP trends. Stays informed of FDA and ICH Guidelines related to GMP (Commercial & Development).

Benefits

• This position is eligible for Alvogen’s annual discretionary bonus and comprehensive benefits package, consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts.
• Alvogen’s benefits package also includes a retirement savings program, long-term care coverage, paid time off (176 hours per year, prorated to hire date) inclusive of sick time, disability benefits, life insurance, a wellness program, and 13 company recognized paid holidays per year.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees