Thermo Fisher Scientific Quality Site Head in Bedford, Massachusetts
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.
Summary of position:
The Quality Sr. Manager reporting in to the Sr. Director of Quality for the Bioproduction division will be responsible for the overall quality management system for the Bedford Massachusetts site. This position will manage quality personnel to achieve Quality objectives and insure compliance with industry standards and customer expectations for purification products used in pharmaceutical manufacturing. The person in this role will determine, organize and apply necessary resources to meet identified Quality initiatives and insure that Corporate, Regulatory, Quality requirements are met. As the Quality site head, the role will also focus on insuring that staff engagement is maintained at a high level through development planning, Gemba, skip level and 1:1 meetings. The role will also collaborate with other Quality site heads within BPD on division-wide initiatives that are focused on enhancements to the quality system in order to meet expectations placed on our customers and insure harmonization of processes so that the customer experience is the same across all products.
Responsible for working with Site Leadership Team to deliver on site goals and objectives
Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates best practices, and is consistent with the strategic plan.
Support and provide expertise to the Quality Management System (QMS) and Quality department to successfully meet or exceed goals and targets
Educate and mentors employees on the site QMS and other quality/operational programs and processes
Provide the necessary leadership and strategic planning to develop, implement and maintain a quality assurance and quality control program to support the business mission and ongoing continuous improvement effort.
Formulates and oversees maintenance of quality control objectives and coordination with production procedures to maximize product quality.
Instill and maintain a quality culture.
Provide input and direction to resolve quality related issues through proper inspections, root cause analysis and corrective actions plans.
Apply quality risk management in order to facilitate a culture of risk identification.
Ensure continuous improvement through the Practical Process Improvement (PPI).
Serves as key member of product teams, with focus on quality planning for new products/processes.
Monitors quality performance for the Bedford site, reports progress, and keeps leadership informed of progress, issues, corrective action, and customer complaints.
Provide direction to ensure compliance with all applicable customer requirements and government regulations involving product quality.
Proven communication and customer management skills
Hands on knowledge of products and applications
Understands the BioProduction customer and required compliance regulations for our products and processes
Experience working and providing customer support, investigations, and relationship management
Must model the highest degree of moral and ethical behavior
Must maintain confidential information
Experience working successfully in a fast paced environment
Experience supporting change management efforts
Proactive and takes ownership for producing positive results
Contributes as a valued team member and colleague with leaders at all levels
Demonstrates personal awareness and desire for continual learning and personal development
Keeps commitments; exhibits candor and courage - is not afraid to establish a visible presence and point of view, to engage in spirited and constructive debate, to hold others accountable
Normally receives little instruction on day-to-day work, general instructions on new assignments
Must possess the presentation skills and professionalism to project a professional image, both internally and externally.
Strong interpersonal, verbal and written communications skills are essential
Required Qualifications :
Bachelor’s degree from an accredited higher learning institution
8+ years Quality experience
3+ years experience leading a team
Experience working in a manufacturing and/or production environment
Good understanding of customers, products, and regulatory compliance
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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.
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