Senior Quality Relationship Manager

SUMMARY OF POSITION

The Senior QRM (Quality Relationship Manager) of Sterile Products and Medical Devices is a member of the US Quality department. In this position, the Sr. QRM will be interacting primarily with Alvogen's external business partners/CMOs. The incumbent will be responsible for overseeing multiple complex sterile products and medical devices throughout the entire lifecycle of the product (i.e., from development through discontinuation) and supporting adherence to Alvogen's quality management system.

The position will require in-depth knowledge of Quality Systems, including activities such as review and release of complex sterile, medical device and combination products, process validation, technical transfer of processes to/from CMOs, troubleshooting/investigation support, change controls, product release, continuous process verification, etc. 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.

ORGANIZATION STRUCTURE

RESPONSIBILITIES

1) Provide guidance and supervision to direct reports, which includes goal setting and performing annual performance reviews.

2) Independent oversight of multiple CMO/CLO and product lines supporting the below functions. This position will have oversight and will work

directly with the CMO for these products and will also have oversight of a direct report(s) assisting in these activities.

3) Documentation Review & Approval:

• Review and approve documentation such as Method and Process Validations, Manufacturing Records, SOPs, Investigations, Change Controls, Validation Reports, Equipment Qualifications and similar documents as directed by Quality Management.
• Release of product to commercial market (US and ROW)

4) Inspections and Audits:

• Prepare / Support / Participate in activities for regulatory inspections and internal/external audits.
• Evaluate regulatory agency findings from inspections conducted at CMOs/CPOs/analytical Laboratories, etc.

5) Support the design and implementation of system/process improvements where opportunities are identified (Commercial & Development), including associated CAPAs.

6) Support technical transfer/validation activities with internal and external business partners / CMOs.

7) Manage the Commercial Finished Product / Bulk Drug Product / Drug Substance 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.
• Release product to commercial market.
• Work with partners for ROW supply and requirements.
• Ensure Quality Systems are in place to handle different requirements for products approved / to be approved ROW.
• File, retrieve, and maintain organized records.

8) Communicate with external business partners / CMOs regarding quality related issues and Quality Agreements.

9) Provide investigation/troubleshooting 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.

10) 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.

11) Review Annual Product Reports /Product Quality Reports.

12) Change Management Program:

1. 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).
2. Maintain change control electronic records in EQMS.
3. Review, assess, and approve change controls as required by SOP's.

13) Support the corporate Training Program when/if needed.

14) Support the corporate audit program as needed/required.

15) Keeps abreast of industry regulations and cGMP trends. Strong knowledge of FDA and ICH Guidelines related to GMP (Commercial & Development), with emphasis on medical device requirements.

QUALIFICATIONS

Position requires the following education and qualification prerequisites:

1) Experience in managing direct reports.

2) BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 15 years' experience in the Pharmaceutical Industry preferred, with a minimum of 10 years in a quality organization. Other degrees will be considered based on extensive industry experience.

3) Experience in GxP laboratory practices, ability to review and assess data.

4) Release of materials and products supporting both development and commercial activities.

5) Has knowledge of GxP quality systems, US FDA regulations, USP and ICH guidance documents. Knowledge of EudraLex a plus.

6) The position requires a strong knowledge of cGMP and US FDA regulations. Knowledge of US and EU combination product regulations and standards, such as 21 CFR Part 4 and ISO 13485, is preferred.

7) Experience with various complex manufacturing/filling processes associated with 'sterile' drug products and medical devices.

8) Experience in troubleshooting and conducting investigations.

9) 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.

10) Strong technical writing and computer skills also required.

11) 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, he/she 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% of business travel is required to go to external Contract Manufacturing Organization (CMO) / Business Partner sites or attend professional development training seminars - as needed/directed.

GMP DECISION-MAKING AUTHORITY

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