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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

Job Description

Thermo Fisher Scientific Inc. is seeking a highly motivated and experienced individual to join our team as a Sr. Manager, Quality. In this role, you will have the opportunity to make a significant impact by building a customer-focused quality culture and implementing industry-leading quality processes. You will play a key role in optimizing the customer experience and ensuring that our products and services meet world-class quality standards.

As the Sr. Manager, Quality, you will be responsible for:

• Creating and leading the strategy for Quality and Compliance, offering guidance to team members and leaders in various functions.

• Serving as an expert in the interpretation of GMP compliance requirements.

• Providing Quality leadership for the Production Chemicals and Services (PCS) multi-site network.

• Building professional relationships with Quality counterparts within customer organizations.

• Coordinating collaborations with various teams within Thermo Fisher Scientific to ensure seamless alignment of product value stream interactions.

• Driving resolution to quality issues and effectively communicating with senior leaders and diverse audiences.

• Mentoring and coaching team members and peers.

• Manage site Quality Management Reviews

• Manage validation, change control, CAPA and complaint management processes and review boards

• Applying Quality Risk Management to prevent failure modes that impact the supply of consistent quality products and services.

• Participate in the evaluation and selection of critical suppliers and service providers

• Partnering with Global compliance and regulatory teams provide guidance and interpretation on applicable QMS GMP standards, customer requirements, regulations, standards and quality systems

Requirements:

• Bachelor's degree or above in Science, Engineering, or related fields.

• 7+ years of experience in the Pharmaceutical, Medical Device Industry, or similar fields.

• Strong knowledge of Quality Management System design and oversight.

• Excellent communication skills, both written and verbal.

• Experience with quality standards and key quality tools.

• Training/understanding in Lean Sigma/Six Sigma processes.

Join our team and be part of a company that is dedicated to making the world a healthier, cleaner, and safer place. Apply today at [insert application link].

Thermo Fisher Scientific Inc. is an equal opportunity employer and is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation to apply for one of our jobs, please contact us at 1-855-471-2255*. We value diversity and encourage applicants from all backgrounds to apply.

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.