Job Information
ThermoFisher Scientific Director, QC in Monza, Italy
Job Description
As part of the team at Thermo Fisher Scientific, we do meaningful work, that makes a positive impact on a global scale! Join our 120,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and enable the future of scientific advances. Our work enables groundbreaking biopharma research, advances precision medicine and supports the innovation of advanced materials, such as next-gen batteries and semiconductors.
Position summary
The Director, Quality Control will lead all areas of the Quality Control Department (Chemistry, Microbiology, Analytical Development, Packaging) in close partnership with Site Quality Head, Site Quality Leadership Team and other Site functions (Operations, Supply chain) of our Monza Site.
Overall Team: 350 colleagues
Key Responsibilities:
To embrace the 4-I values of Integrity, Intensity, Innovation and Involvement by role modeling the values.
To set strategy and direction for Quality Control department, ensuring continuous improvements regarding the most recent national and international cGMP compliance standards and accomplishing compliance in the most efficient way. Advise quality top management on issues that may affect the site and/or Thermo Fisher Scientific as a whole.
To staff, train, retain and develop an impactful Quality Control Team and act as a role model leader for the entire organization, creating successful work environments and inspiring a culture of continuous feedback and inclusion.
To deliver RFT, OTD and other departmental KPI targets within the identified timeframe.
To lead the QC consumables purchasing budget.
To lead the stability programme, reserve sample storage and cleaning validation programme.
To provide oversight to the QC processes which are common across sub departments.
To write and approve technical documentation within the department.
To maintain a thorough understanding of and compliance with international cGMP, and regulatory requirements
To assure quality problem solving, ensuring GMP compliant and pragmatic solutions are in place.
To communicate optimally with others on-site and throughout the corporation, to participate with them in planning and problem solving activities as required.
To plan adequate resource for the department to ensure compliance with regulatory, cGMP’s, site procedures, corporate and client requirements, including lead times.
To sponsor and support Global QC projects as well as their roll out at a site level.
To promote Lab productivity and Innovation according to the our values and initiatives.
To manage the validation of laboratory equipment and testing methods.
To manage introduction of new products.
To support internal and external audits where required, being present and supporting any GMP regulatory and client audits.
To ensure that all health and safety procedures within the department are adhered to with respect to personal duties and duties of others.
To ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
To perform any other tasks which may be required from time to time.
Requirements:
Degree or equivalent in Chemistry, Pharmacy, life sciences or a related field.
15+ years of cGMP experience in the pharmaceutical industry.
Sterile manufacturing experience is required for the role.
Experience implementing Digital Systems for Lab execution is a strong plus.
10+ years in a leadership role, ideally in a international environment.
Experience leading large teams and inspiring organisational change initiatives in complex/high-growth laboratory organizations.
Capability to network and collaborate optimally with other functions within the site and other Quality units in a global network.
Strong Coaching skills.
Good judgment in time critical situations and analytical thinking.
Continuous improvement attitude.
Business minded and customer focused.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.