Product Quality Manager Eqa - Sterile And Organon Lazio

Product Quality Manager Eqa - Sterile And Organon
Roma
Lazio, Lazio

An amazing opportunity has arisen for a **Product Quality Manager**.

The Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analysed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements.

Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Party manufacture and release by means of risk-based quality oversight and on-site supervision, as appropriate.

**What you will do**:

Bring energy, knowledge, innovation and leadership to carry out the following:

- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records

- Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer

- Provide support for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented

- Oversee repackaging activities in the External Party

- Conduct routine analytical change requests and support process modification change controls

- Stability Program management, including review of stability reports, and Annual Product Review assembly

- Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements

- Track and monitor operational and quality performance of the external manufacturer/partner

- Assist the maintenance of retention samples, ship reagents and samples to support license and foreign registration; responsible for shipment under quarantine

- Support routine process validation; review and approve validation reports/tech transfer

- Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes

- Regular site visits to build relationships and monitor efforts to improve the external manufacturer's quality and reliability through ongoing oversight and formal communication programs and forums

**What skills you will need**:

In order to excel in this role, you will more than likely have:

- Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).

- Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred

- Solves complex problems; takes a new perspective using existing solutions

- Works independently, receives mínimal guidance

- Acts as a resource for colleagues with less experience within own discipline; can provide mínimal guidance on issue resolution and act as SME

- May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others

- Explains difficult issues and works to build alignment around a complex situation

- Accountable for a medium sized project with mínimal resource requirements, risk and/or complexity

- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills

- Communicates easily in English both verbally and in writing

- Strong knowledge of External Manufacturing management, supply chain, and operations

- Lean Six Sigma Systems training an advantage

As a company, we are committed to 'Inventing for Life' in all that we do.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

**So, if you are ready to**:

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).

Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external st