Janssen Italy - Operations Sr. Manager LATINA

Janssen Italy - Operations Sr. Manager
Latina
Lazio, LATINA

Are you a strong leader with a passion for Operations?

If you want to play a leading role making our Launch & Grow site in Latina future proof, this role may be just fit for you!

The Latina site is the most innovative drug product (DP) manufacturing site in the Janssen Supply Chain Small Molecule Platform.

We ensure our life saving medicines reach the patient, safely, reliably, competitively, always.

As the DP Launch and Grow site for Small Molecule platform, the site is closely connected, with our R&D partners and with our API launch site in Geel, Belgium.

As the **Operations Sr.

Manager**, you play a central role in leading the production results and production strategic programs toward our Latina 2030 aspiration.

You will be based in Latina, Italy and report directly to the Operations Director.

You will have also a central role in developing talents within the organization.

You require excellent Operational and Stakeholder Management skills and will be accountable to deliver ground-breaking goals with confirmed business value.

To achieve this, you partner with the local teams within QA, Planning, MAM, TechOps and IT as well as platform and global functions.

The role requires solid experience in operations and knowledge of the Pharmaceutical processes and a strong ability to coach and mentor operations teams.

**Key responsibilities**:

- As Process execution owner of Manufacturing and Packaging systems, guarantee the compliance, the adherence to the rules and the procedures of the assigned process relating the 'Production' system

- Assure and contribute to the definition and implementation of the procedures and monthly/annual/daily working plans according to the GMP procedures and to the operational and budget standards, improving the available resources

- Assure the direct supervision of the operators, together with the Manufacturing Mgr and Spv, the performance of the department through the management of shifts, holidays, leave assuring the activity from a quality, costs and time, required by the operational standards, perspective

- Guarantee that the activities of new products launches are performed according to the appropriate resources in the expected time

- Collaborate closely with the local teams to guarantee the strategic development of the department to promote the continuous innovation and implementation of the digital transformation of the site

- Guarantee administrative and safety related support to all people, regardless of hierarchical responsibility, supporting them in case of need and in case of operational difficulties; seeking contact, when possible, with those directly responsible and ensuring that both internal and departments conflicts are resolved and / or managed within the context of individual and corporate relationships

- Interact with the other company functions to achieve better synergy and reduce the productions cycles guaranteeing personal intervention to solve critical operational issues

- Define priorities for the validations of the new production manufacturing processes, contributing to the verification of the related protocols and action plans and participating in the start-up of the new production lines

- Guarantee the adequacy of the skills of the human resources through periodic assessments to identify effectively and timely management solutions, training and development of skills and motivation solutions.

- Ensure that products are manufactured and stored as described in the respective documentation to guarantee the required quality of the product

- Approve the instructions related to the production activities and to ensure their correct implementation.

- Ensure that the staff of the department is appropriately trained to carry out the required activities and that all tasks are carried out by authorized personnel

- Ensure that the required validations are executed in the production department

- Ensure the maintenance and retention of records related to the activities performed by the department according to the GMP requirements and in compliance with the J&J standards

- Ensure the implementation of documented investigations in case of any discrepancies with existing practices and operating procedures and ensure the provision of necessary changes to monitor those factors that could impact the quality of the finished product

- Approve access to IT systems, where required, as owner and / or alternative signatory, for functions related to the department

- Ensure that production records are evaluated and signed by authorized personnel; ensure that Batch Record Review is carried out in the production area, carrying out all checks foreseen in parallel / in support of the Quality Assurance department

- Identify the personnel responsible for carrying out firefighting and first aid measures; guarantee the provision to personnel of PPE (individual safety devices); provide personnel information and training on safety, health and environment

- Monitor any changes affecti