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 Systems & Compliance will be a valued member of the Site Quality Leadership team. The Director will ensure that the overall cGMP compliance profile of the site is maintained specifically in the development, implementation and maintenance of quality systems to support operations in a manner consistent with global quality systems requirements, corporate standards, current regulatory requirements and client requirements. The scope of the position includes the oversight and leadership of Quality Audits and Regulatory Inspections; Quality Systems; Validation Quality Assurance; Document Control & Change Management.

Overall Team: 65 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 Systems and Compliance department, ensuring continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish 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 Systems and Compliance team and act as a role model leader for the entire organization, crafting successful work environments and inspiring a culture of continuous feedback and inclusion.

• To support and facilitate the implementation of the Pharmaceutical Quality System, ensuring timely updating to the cGMP regulations and Corporate Standards.

• Quality Audit and Regulatory Inspection:

• to lead the team that ensures that that site remains client audit and regulatory inspection ready at all times with 10 Regulatory Inspections from major International agencies (FDA, AIFA, etc) and 45 client audits per year.

• to ensure that internal audit program is robust and appropriate to identify areas of improvement including the development of suitable corrective and preventative actions.

• To coordinate review and response to observations including the development of suitable corrective and preventative actions

• To maintain audit and inspection schedule

• To review and report findings to site leadership

• To track and report regulatory industry trends with respect to regulatory compliance.

• Quality Systems:

• To ensure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems.

• To manage staff that performs reporting and tracking of site Key Performance Indicators; review and assessment of Corporate Standards; annual Product Review; data Integrity; Quality Risk Management and Quality Project Management.

• Validation Quality Assurance:

• To implement the overall quality strategy for the facility with respect to validation.

• To coordinate all aspects of QA Validation operations within the facility (equipment and instrument validation, method validation, data integrity, computer systems validation), deviation investigations, change controls, customer quality support and SOP review.

• Document Control & Change Management:

• To provide oversight and execution of creation, routing, approval and issuance of critical documents and records that support all phases of product operations.

• To lead the team coordinating change controls with customers and ensure documentation/record changes are approved by customers per quality agreements.

• Additional responsibilities include Continued Process Verification (CPV) and Electronic Execution Systems (Documentation, Change Control, Deviations etc.)

Requirements:

• Degree in Chemistry, Biotech or Pharmacy or equivalent.

• 15+ years of cGMP experience in the pharmaceutical industry. Sterile manufacturing experience as well as experience leading regulatory inspections are considered mandatory for the role.

• Track record of strong involvement with industry professional associations (ex. PDA) is considered a strong plus.

• 10+ years in a leadership role, ideally in an international environment.

• Qualified Person nomination by AIFA is a strong merit.

• Fluency in English is considered mandatory for the role. Fluency in Italian is a strong merit.

• Change Management and influencing skills.

• Capability to network within the pharmaceutical industry and partner strategically with international regulators.

• Capability to collaborate effectively with other functions within the site.

• Listening, negotiation and effective communication skills under pressure.

• 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.