Site Head Of Qa Compliance Monza

Site Head Of Qa Compliance
Monza
Lombardia, Monza

MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES**:

Ensure that site operations meet cGMP and regulatory compliance while respecting European and International Regulations, Corporate Standards and Clients requirements, through the guidance, coordination and control of the reporting structure.

Promote proper and proactive business partnership with site functions.

Facilitate people and organization development.

**ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES**:

**Quality Systems & Compliance

- Support and collaborate with Training&Quality System Team to implement the. Pharmaceutical Quality System, according withcGMP regulations and Corporate Standards

- Ensure a proactive site cGMP inspection readiness program, evaluating potential gaps, identifying action plans in collaboration with the involved functions and providing follow up

- Ensure the proper preparation, management and follow up of Regulatory Authorities and Clients inspections

- Ensure timely execution of the internal and external auditing program

- Ensure proper management of suppliers

- Ensure timely preparation of APRs

**Validation and Calibration

- Collaborate with technical Services to ensure that equipment validation and calibration activities meets cGMP and Corporate Standards

- Ensure that production processes and cleaning validation meet cGMP and Corporate Standards through the guidance, coordination and control of the reporting structure

- Ensure that an effective and complaint change control system is in place

**Organization Management

- Manages performance and development of collaborators to ensure achievement of personal and site goals as well as a "great place to work" environment

**Budget

- Support the Quality Director in the budgeting process

**RELATIONS**:

**Internal

- All the Monza operational functions

- Patheon Sites and Corporate depts.

**External

- Clients, Regulatory Agencies

**REQUIREMENTS

**ESSENTIAL

- Degree in a Scientific Area

**Technical skills**:

- Practical knowledge in GMPs and Regulatory Compliance

- Familiarity with production, validation and supply chain processes.

**Professional Experience**:

- At least 10 years of experience in Pharma Operations.

- Experience in Quality Units of pharmaceutical company.

- Experience in people management and development

**Foreign Languages**:

- Italian

- English

**Personality traits**:

- Leadership, including change management

- Team work

- Listening, negotiation and communication skills

- Strategic thinking

- Pragmatic and oriented to prioritization and results achievement

**(B) DESIRABLE**:

- Knowledge of Sterility Assurance.

- QP nomination by AIFA