Quality Head, Mrna Business Monza

Quality Head, Mrna Business
Monza
Lombardia, Monza

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.

Your work will have real-world impact, and you'll be supported in achieving your career goals.

**Location/Division Specific Information

This role is supporting our mRNA business, located in Monza, Italy

**How will you make an impact?

This role serves as Site Quality Head for mRNA at our Monza Site.

Leads and manages site Quality related programs and activities to support the contract manufacturing organization and multiproduct manufacturing operations.

This role oversees Quality Assurance review and approval, Product Release activities, supports Quality Systems, and Document Control.

Additionally, this role is responsible for all mRNA testing activities.

Ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

The position reports to the Quality Head of the Advanced Therapies Division and has a dotted line reporting structure to mRNA business head.

**What will you do?

- Actively participates as a member of the mRNA Quality Leadership Team and partners with the Operations management.

- Provide operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints

- Manages team of managers and professionals within Quality.

Hires and develops employees within the department.

Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.

- Supports development of appropriate operating and capital expense budgets and strives to have the Quality organization contribute to COGS improvement.

- Accountable for regulatory inspections and client audits.

- Support establishment and/or enhancement of Quality metrics and mitigation strategies where appropriate.

- Lead and/or support establishment of electronic Quality systems for site, and in conjunction

- Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement.

- Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed in order to proactively support business processes.

- Guarantee a suitable and efficient organization, an appropriated resources definition and management, relevant budget included

**Additional Duties and Responsibilities

- Ability to write reports, business correspondence and procedure manuals

- Strong organizational skills; ability to prioritize and manage through complex processes/projects

- Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents

- Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community

- Ability to effectively present information to employees, top management, public groups and/or boards of directors

- Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical or diagram form

- Ability to define problems, collect data, establish facts and draw valid conclusions

- Ability to deal with abstract and concrete variables in situations where only limited standardization exists

- Ability to utilize various standard programs for data entry and word processing

- Ability to utilize software and customized programs to meet business needs

**How will you get here?

- ** Education

- BS in a scientific/technical discipline

- ** Experience

- 10+ years of experience in a quality leadership position, or>15 years progressive management experience with GMP responsibilities within the biological and/or pharmaceutical industry.

- Significant experience in supporting functional areas (e. g.

R&D, Manufacturing, QC, Engineering, EHS, Tech Services) preferred.

- mRNA manufacturing experience highly desirable

- ** Knowledge, Skills, Abilities

- Excellent communication skills

- Ability to multitask, strategically and tactically

- Solid knowledge of FDA, EMA and local regulatory requirements applicable to biologics or pharmaceuticals.

**Languages**:

- English

**Personality Traits**:

- Steadiness

- Leadership

- Negotiation skills

**Other Job Requirements**:

- Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.

- Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing

- filing - writing

At Thermo Fisher Scientific, each one of our 75, 000 extraordinary minds has a unique story to tell.

Join us and contribute to our singular mission—enabling our customers to make the world healthier