Quality Assurance Manager (m-f-n)

Project Name: Global Quality Assurance Agreement (QAA) Management

Project Description:

Autonomous compilation, revision and management of Quality Assurance Agreements (QAAs) and Intercompany QAAs, Amendments to QAAs and Participation Agreements.

These documents are required to conduct any GMP activity for the clients or for any internal activity in compliance with regulatory requirements and contracts with clients and BI contractors.

The scope of services includes the following tasks, which are independently performed by the external contractor:

Workpackages (New global QAAs; Revision of QAAs, Participation Agreements, Amendments and Intercompany QAAs):

QAAs describing roles and responsibilities for quality topics between the involved parties are a mandatory supplement to business contracts in our Contract Manufacturing as well as BI internal business. They have to fit to overarching business contracts. Therefore they have to be either newly generated (in case of new global customers/business relationships) or amended (e.g. in case of an additional product to be covered within an existing global business relationship). This must be done timely and in parallel to the business contract.

The respective QAA activities are requested from Key Account Managers or Project/ Product Managers responsible for and negotiating the respective business contracts. This information will be handed over to the contractor upfront. The contractor will receive a list with requested deliverables.

For new Global QAAs:

-   Writing of new global QAAs for Contract manufacturing business (CMB) with clients, Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs) based on BI provided template

-   Negotiation of these QAAs with CMB, CMO and CLOs according to BI guidance Do's and Donts which are defined in BiWiki and are provided upfront. Negotiation progress and results must be documented and provided to BI

-   Provision of finalized Draft document to BI for signature and archiving in provided system CorA and IDEA the freelancer was trained and got familiar with upfront

For Revision of QAAs, Participation Agreements and Amendments:

-   Writing of Amendments, Participation Agreements (PA) and revision of existing global QAAs for Contract manufacturing business (CMB) with clients, Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs) based on BI provided template

-   Negotiation of these Amendments, PAs and QAAs with CMB, CMO and CLOs according to BI guidance Do's and Dont's which are defined in BiWiki and are provided upfront. Negotiation progress and results must be documented and provided to BI

-   Provision of finalized document Draft document to BI for signature and archiving in provided system CorA and IDEA the freelancer was trained and got familiar with upfront.

For BI Intercompany QAAs:

-   Revision of BI intercompany QAAs based on BI provided template

-   Negotiation of those QAAs within BI according to BI guidance Do`s and Dont`s which are defined in BiWiki and are provided upfront. Negotiation progress and results must be documented and provided to BI

-   Provision of finalized draft document to BI and archiving in provided system CorA and IDEA the freelancer was trained and got familiar with upfront.

Timely preparation of quality assurance agreements being in compliance with regulatory requirements and underlying contracts with BI clients as well as BI contractors.