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ASSOCIATE DIRECTOR- QUALITY AND REGULATORY AFFAIRS-GMP

BRIDGEWATER, NJ
We are currently in the process of creating EUROAPI the future leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients (API).

EUROAPI will represent the “made in Europe” API state-of-the-art industrial capabilities and technologies, with approximately €1 billion in expected sales by 2022. It will be rank number 1 in small molecules API, and number 2 on the global API market2. Addressing recent increasing medicine shortages that critically impact patient care, EUROAPI will ensure additional API supply capacities for Europe and beyond, and help balancing the industry’s heavy reliance on API sourced from other regions

Within EuroAPI US organization, oversees, coordinates & maintains registration dossiers required for the EuroAPI Sales activity in North America (US & Canada). Manages Regulatory Affairs (RA) in accordance with local regulation and Sales strategy. Contributes to EuroAPI Quality & Regulatory network with Global organization, manufacturing sites and Health Authorities. Coordinates the regulatory operations and business processes to support activities locally, acting as customer interface. Records of key Regulatory processes and reports KPIs for Customer Excellence policy and regulatory compliance. Defines the Quality Management System of EuroAPI US legal Entity Acts as Quality focal point for any QA aspects relative to distribution of products marketed in North America such as distribution deviation, complaint, 3PL management.

At EuroAPI, we develop, manufacture and supply active pharmaceutical ingredients (API) and technological solutions for our markets across the world.

We leverage our industrial expertise and experience to meet the highest quality requirements while focusing permanently on our customer’s satisfaction.

EuroAPI, part of our company, is currently in a carve-out process with the intention to become an independent and listed company by 2022, depending on market conditions.

Job Highlights:

Management of North American Regulatory activities:

*Development of new registrations and maintenance of EuroAPI North America portfolio:

-Manages Regulatory Policy of the zone in relation with Regulatory Global functions.

-Ensure the Regulatory compliance of the DMF registered in the region.

-Trains Regulatory Site Officers of Chemistry/Biochemistry sites on US & CA Regulation.

-Ensures adequate management of registration dossiers portfolio and dossier submission according agreed planning (Regulatory LRP). 

- Ensures annual reports are submitted at the due date.

*Provides advice to the manufacturing sites when needed to answer to questions from Health Authorities (HA).

*Actively contributes to the Change Control process as soon as North American Region is concerned.

*Acts as the US agent for EuroAPI US legal entity. Role of key interlocutor of the US Health Authority

Quality focal point in North America for Distribution activity:

*Defines the Quality Management System of EuroAPI US legal Entity:

- Applies and be warrant of in-place/in-use global SOP dealing with distribution activity in EuroAPI US Legal Entity.

- Writes and approve local SOP/instruction relative to distribution activity of EuroAPI US legal Entity referring to GDP

- Trains newcomers in EuroAPI US legal entity about GDP rules, IT tools and global SOP for distribution

*Acts as Quality focal point for any QA aspects relative to relative to distribution of products marketed in North America such as distribution deviation, complaint, 3PL management (transportation and warehousing), ...

*Acts as entry point to manage the requests relative to distribution failure (on out-bound materials shipped either by indent or ext-stock flow and on in-bound materials) raised in US market.

*Manages the 3PL relationship as Quality first contact for any quality request, warehouse deviation and CAPA, QAA revisions, product list revisions and customer request to audit 3PL warehouse

Basic Qualifications:

Bachelor’s degree in Pharmacy, Chemistry/ Biochemistry.

*Minimum of 10 years in the pharmaceutical industry with knowledge in Regulatory Affairs and/or Quality Assurance.

*Knowledge of North America Regulations: US FDA and Health Canada.

*People Management Skills

*Experience in active ingredient production, Analytics, Quality Assurance and registration regulations.

*GMP Experience
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
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KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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