Sr Manager, Quality

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

As the Sr Manager, Quality, you will have the outstanding opportunity to craft and drive a culture of excellence within our Engineering team at Thermo Fisher Scientific Inc. We are looking for an exceptionally dedicated individual to ensure our products and processes meet world-class standards, aiding us in fulfilling our mission to enable our customers to make the world healthier, cleaner, and safer!

Location/Division Specific Information

This role is part of the Biologics and Chemicals Division, located at our PCS main office in Morrisville, NC.

What will you do?

• Develop and lead Quality and Compliance strategy and provide compliance and risk management advice to collaborators and functional leaders. Ensure adequate deployment and execution of such strategy.
• Serve as an expert in the interpretation of GMP compliance requirements and expectations.
• Provide Quality leadership for the PCS multi-site network, composed of 8 PCS sites, including a 3PL arrangement in Dublin, Ireland.
• Build professional relationships with Quality counterparts within customer organizations.
• Manage matrix relationships within Thermo Fisher Scientific to ensure all product value stream touch points are aligned to deliver Quality products and processes.
• Drive resolution to quality issues and communicate internally to senior leaders and diverse audiences effectively. Solve problems in complicated situations using analytical skills, creativity, judgment, and technical expertise. Partner with other SMEs as needed.
• Provide training, mentor, and coach team members and peers.
• Apply Quality Risk Management to prevent risk of failure modes that impact the supply of consistent Quality PCS products and services.
• Conduct advanced data analyses to determine quality problems and identify larger scale quality improvements.
• Partner with Global compliance and regulatory teams to provide mentorship and interpretation on applicable QMS GMP standards, customer requirements, regulations, standards, and quality systems.

Education

• Bachelor’s degree (required) in Science, Engineering or other technical area

Experience

• 7+ years or more experience within the Pharmaceutical, Medical Device Industry or similar fields
• Audit (ISO, GMP, IPEC or similar) or inspection management experience
• Customer facing experience
• Clean room experience preferred
•  Supplier Management experience required

Knowledge, Skills, Abilities

• Expert knowledge of Quality Management System design and oversight from a pharmaceutical perspective
• Strong communication skills, both written and verbal. Experience handling very complex quality issues including partner concerns within the Company and with Customers. This involves direct verbal interaction, detailed communications (email, letters, PowerPoint), and issuing written reports
• Knowledge of Compliance with quality standards (e.g., ISO)
• Experience with the use of key quality tools e.g. FMEA, Risk Analysis, RCA and global systems e.g. TrackWise, AGILE, E1/SAP, LIMS or similar
• Training/understanding in Lean Sigma/Six Sigma processes

Preferred Knowledge, Skills, Abilities

• Proficiency in chemical production processes, pharmaceutical production, pharmaceutical new product introduction
• Knowledge of procurement/supplier oversight including good distribution practices (IPEC)
• Experience in project management
• Understanding of Lean Production System concepts
• Regulatory Affairs Experience and/or RAPS Certification or ASQ Quality Certifications would be a plus
• At least 2 years of experience managing/leading a multi-site organization