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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

How will you make an impact?

The QMS Manager will lead all aspects of the Quality Management Systems team. They ensure site compliance with FDA, EMA, and other cGMP regulations. They coordinate programs such as Change Management, CAPA management, local systems administration, and Metrics. This individual provides leadership by developing and empowering staff. They encourage relationships and put staff in positions to succeed. They support staff in meeting personal career goals while achieving organizational goals. They build effective teams that apply diverse skills and perspectives. They promote engagement and craft a climate where staff are motivated to do their best.

What will you do?

+ Coordinate, manage, and ensure the successful day-to-day operations of the QMS team for the company.

+ Manage the change management program, including planning, execution, oversight, and governance.

+ Review and approve department standard operating procedures.

+ Coordinate daily activities to ensure appropriate quality and maintenance of schedules.

+ Provide support for site safety initiatives.

+ Perform any other tasks as requested by Senior Management to support Quality oversight activities.

+ Represent the company at regulatory inspections, respond to questions, and support responses and corrective actions as appropriate.

+ Set objectives and tasks for staff and regularly review their progress.

+ Effectively communicate with peers, Manufacturing, Process Development, Procurement, and Quality Control staff to resolve technical issues and direct activities.

How will you get here?

Education

+ Bachelor’s Degree or equivalent experience in Life Sciences, Biotechnology, Engineering, or a related field.

Experience

+ More than 8 years of experience in a GMP Environment.

+ A minimum of 5 years' experience in Quality Assurance or Quality Compliance is preferred.

+ 3+ years in a leadership role is preferred.

Knowledge, Skills and Abilities

+ Ability to drive functional, technical, and operational excellence. Ability to encourage and foster innovation, collaboration, transparency, and team efficiency.

+ In-depth knowledge of FDA, EMA, and other applicable regulatory requirements.

+ Proficient with computer (MS Office) and internet skills. Proficient in the use and understanding of controlled documentation and data systems.

+ Well organized and able to work independently with minimal supervision.

+ Skilled in risk management application.

+ Demonstrated dedication to our fundamental principles of Integrity, Respect, and Excellence.

+ Knowledge of pre-license/pre-approval inspection readiness and regulatory submissions is preferred.

+ Experience with regulatory inspections.

+ Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member.

+ Proven ability to influence others and lead significant change.

+ Strong communication and presentation skills, both written and verbal.

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.