Quality Relationship Manager Sterile Products & Medical Devices
SUMMARY OF POSITION
The QRM (Quality Relationship Manager) 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 complex sterile products and medical devices throughout the entire lifecycle of the product (i.e. from development through discontinuation) and is responsible for supporting the adherence to Alvogen’s Quality Management System. The position will require in depth knowledge of Quality Systems including activities such as 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 the partners is essential to ensure compliance and optimal performance.
The QRM reports directly to the Director, Third Party Quality, Sterile Products and Medical Devices. There are no reports, direct or otherwise to the QRM.
Primary responsibilities of this role include, but are not limited to, the following:
- Documentation Review & Approval:
• Review and approve documentation such as Method Validations, Manufacturing Records, SOPs, Investigations, Change Controls, Validation Reports, 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 Commercial Finished Product / Bulk Drug Product Release System:
• 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.
- Provide investigation/trouble-shooting support as needed. Ability to review and approve complex 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.
- Review Annual Product Reports / Product Quality Reports.
- Change Management Program:
a) 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).
b) Interact with regulatory and SMEs for the required deliverables for the change controls.
c) Maintain change control electronic records in EQMS.
d) Review, assess, and approve change controls as required by SOP’s.
e) 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).
Position requires the following education and qualification prerequisites:
- BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 10 years’ experience in the Pharmaceutical Industry working with 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.
- Experience in GxP laboratory practices, ability to review and assess data, especially from a Quality R&D perspective.
- 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 EU requirements a plus.
- Experience with various complex manufacturing / filling processes associated with ’sterile’ drug products and medical devices.
- Experience in trouble-shooting and conducting investigations.
- 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 also required.
- Must display the ability to work independently with little or no supervision and plan and accomplish set goals.
Physical Demand Factors
- While performing the duties of this job, the QRM is required to sit and work at a computer for extended periods of time.
- Is regularly required to talk, listen, and attend meetings / teleconference calls.
- 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 QRM for all the quality management system elements outlined in the Responsibilities section of this Job Description.
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