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1+ months

Sterile Products & Medical Devices Quality Project Manager

Kelly Services
Pine Brook, NJ 07058
**Quality Relationship Manager Sterile Products & Medical Devices (direct hire)**


**Overview:** Kelly Services is seeking an experienced Quality Relationship Manager for a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the counter (OTC) and biosimilar products around the world. This is a direct hire position in Morristown, NJ.


QRM (Quality Relationship Manager) is a member of the US Quality department that handles Sterile/Combo Products and Medical Devices. In this position, the QRM will be interacting primarily with external business partners/CMOs and contract services providers for this segment of products. This individual will have responsibility for oversight of multiple complex sterile products and medical devices throughout the entire lifecycle of the product (i.e. from development through final decommissioning and disposal) and is responsible for supporting the adherence to 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 position will require a strong first-hand knowledge of the regulations and international standards governing Medical Device and Combination Products distributed in multiple commercial markets within the US, EU and ROW i.e., QSRs, ISO 13485 and MDRs. The individual will also support the technical transfer of Combination and Medical Device products to/from various CMOs and the documentation which comprises the Medical device file.


**Duties and Responsibilities**


1. Independent oversight of multiple CMO/CLO and product lines supporting the below functions. This position is an independent contributor and will work directly with the CMO for these products.

2. Documentation Review & Approval:


+ Review and approve documentation such as Analytical Method and Process Validations, Manufacturing Records, specifications, 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)


1. Inspections and Audits:


+ Prepare / Support preparation activities for regulatory inspections

+ Evaluate regulatory agency findings from inspections conducted at CMOs/CPOs/analytical Laboratories, etc.


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

2. Support technical transfer / validation activities with external business partners / CMOs.

3. Manage the Commercial Finished Product / Bulk Drug Product / Drug Substance Release System:


+ Execute 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.

+ File, retrieve, and maintain organized records


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

2. 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.

3. 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.

4. Review Annual Product Reports / Product Quality Reports.

5. 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 SOPs.

6. Support the corporate Training Program, when / if needed.

7. Support the corporate audit program as needed / required.

8. Keeps abreast of industry regulations and cGMP trends. Strong knowledge of FDA and ICH Guidelines related to GMP (Commercial & Development).


**Required Skills & Qualifications**


1. 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 an ISO 13485 certified organization. Other degrees will be considered based on extensive industry experience.

2. Specific product / industry experience must have at least one of the following:

1. Strong sterile manufacturing background from the Quality perspective with combination products (pre-filled vials, pre-filled syringes, cartridges)

2. Sterile background, understanding of API (Drug Substance) process utilizing a cell line from fermentation through purification

3. Experience in GxP laboratory practices, ability to review and assess data, generate or approve CoAs as appropriate.

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

5. Has knowledge of GxP quality systems, US FDA regulations, USP, ISO and ICH guidance documents. Knowledge of EudraLex and Part 4 a plus.

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

7. Experience in troubleshooting and conducting investigations.

8. 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.

9. Strong technical writing and computer skills also required.

10. Must display the ability to work independently with little or no supervision and plan and accomplish set goals.


Please note that resumes from third parties will not be accepted. All candidates must be presently authorized to work for any employer in the US.


Apply today for immediate consideration or send your resume directly to


**Marina.Hart@kellyscientific.com**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-03-19 Expires: 2021-05-13

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Sterile Products & Medical Devices Quality Project Manager

Kelly Services
Pine Brook, NJ 07058

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