Job Description

The Position

As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures that packaging operations can produce material required by Roche\xe2\x80\x99s clinical trials seamlessly, on-time, and while optimizing cost/quality.

Within Production Enablement, the Global Clinical Materials Manager (GCMM) leads the coordination and execution of all procurement activities of drug products and packaging materials for global clinical studies. This includes the coordination of the release of these materials to ensure a timely production of Investigational Medical Products in accordance with international standards and regulatory requirements. Furthermore, the GCMM is responsible for all tasks related to clinical demand planning of packaging material.

\xe2\x80\x8b\xe2\x80\x8bMain responsibility: Single point of contact to ensure availability of drug products and packaging materials to clinical manufacturing. This contains the following responsibilities:

Responsible for the correct master data maintenance of all drug products and packaging materials

Compile product-specific data and documents for drug products and packaging materials

Define, request and continuously update the master data of drug products and packaging materials in SAP-systems

Plan packaging materials in SAP-systems

Manage purchase orders for Roche development drug products, \xe2\x80\x9cRoche-Partner\xe2\x80\x9d drug products, Roche commercial drug products and external commercial drug products from internal and external suppliers in the appropriate procurement system

Manage purchase orders for packaging materials in the appropriate procurement system

Supplier Relation Management: Manage various drug product- and packaging material suppliers to the Clinical Supply Chain Organization, incl. creating suppliers performance transparency with KPIs and taking applicable actions for continuous improvements

Support of warehouse in goods receipt questions

Perform virtual goods receipts

Responsible for ensuring batch availability of drug product and packaging materials for further manufacturing

Manage the compilation of a GMP- and customs-compliant goods receipt dossier for the QA-release of drug products and packaging materials

Maintain GMP and non-GMP-batch data of drug products and packaging materials in SAP

Ensure the on time QA-release or AFM (\xe2\x80\x9cAuthorization for Further Manufacturing\xe2\x80\x9d) of drug products and packaging materials

Handle shelf-life extensions

Manage the shelf-life extensions of packaging materials at batch level

Manage the shelf-life extension of drug products at material and batch level including the associated documentation

Confirm the quantities received to enable accurate cost charging of drug products and packaging materials in the relevant financial systems

Drive and lead the issue management for global clinical supply concerning the procurement of drug products and packaging materials as well as the goods receipt of drug product

GMP Deviation- and Change Management

Actively support inspections

Actively monitors Key Performance Indicators (KPIs) for team- and vendor-performance and works independently to develop ideas and initiates continuous improvements

Lead and participate in global / local projects to optimize Clinical Supply processes

Collaborate with Business Process Managers to exchange ideas, drive process improvement, and resolve issues on both global and local level.

Support system improvements, create and update SOPs and other department/training documents which support daily business

Works independently on system improvements in SAP CLARA P96

Job Requirements and Qualifications

Competencies

\xe2\x80\x8bSolid understanding of the Pharma Supply Chain and clinical packaging processes

High cultural awareness and social competence required as cooperation and communication in complex situations with different cultures and countries is part of the daily job

Well-developed teamwork, collaboration, and negotiation skills

Possess strong problem solving and decision making skills, high attention to detail, and understanding of systems and technical designs

Full use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques

Ability to adhere to procedures and standards in a GMP environment

Ability to manage projects from initiation to delivery

Ability to work independently and set priorities. Self-motivated, proactive, quick thinking, adaptable

Ability to communicate clearly and professionally both in writing and verbally (Excellent English skills)

Customer-focused, ability to create trustful relationships with business partners

Ability to quickly learn a broad range of skills

Required Experience

3+ years experience in the pharmaceutical, biopharmaceutical industry and/or Supply Chain Management,

Experience with SAP ERP systems

Experience with MyBuy system preferred

Education

Associate level of professional education or University degree in the pharmaceutical, biopharmaceutical or Supply Chain Management, or a Master\xe2\x80\x99s Degree

APICS and/or SCOR certification, or equivalent relevant experience

PMP/Operational Excellence/Six Sigma/Lean training a plus

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche\'s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

Roche