Director Quality and Regulatory Compliance North America

At Thermo Fisher Scientific we offer employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Position summary:

As the Director of Quality and Regulatory Compliance for North America, you are crucial to ensuring that the organization’s products and services are in compliance with the company’s quality system and continuously improving quality and compliance for our customers and regulatory authorities.

You will report directly to the VP of Quality and Regulatory for the Microbiology Division, and partner directly with site leaders and business partners at facilities in Lenexa Kansas, Oakwood Village Ohio and Ottawa Canada. You will be an integral part of the North America Leadership team.

Group/division summary

The Microbiology Division provides solutions and workflow for food, clinical, and pharmaceutical environments. The markets we serve include food manufactures and labs, clinical and healthcare, pharma and biotech.

Attributes

You will provide vision, role-model leadership, and command with a high degree of emotional intelligence.

You are a role-model leader, generating passion and building effective working relationships; with an ability to influence in distributed team settings. You will be skilled at problem-solving and conflict resolution to build an excellent outcome for all colleagues and achieve results.

You will honor commitments and strive for positive professional relationships with subordinates and peers.

Key Responsibilities:

• Lead a staff of 6 quality leaders (combined staff of approximately 80 quality professionals)
• Drive a risk-based approach to decision making with business partners and your teams across the North America site locations
• Function as the Management Representative for your sites to external agencies
• Report on the performance of your sites quality system including Quality metrics
• Develop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production of products, including suppliers and OEM
• Review and resolve quality and regulatory challenges / opportunities with other functional partners including vendors, customers and regulatory agencies
• Coordinate and assist with regulatory and notified body, customer and vendor inspections
• Lead all aspects of the internal audit program and support development of corrective action plans and ensure timely resolution of findings
• Provide insight for the business through accurate data analytics

Qualifications:

• Minimum Bachelor's Degree in Engineering or Sciences. Microbiology is preferred.
• 8+ years of professional experience in quality and regulatory management systems in a regulated environment
• Medical device/IVD experience
• Confirmed experience in driving meaningful improvements of quality performance across a broad range of initiatives including development and recruitment of talent, and the elimination of exceptions/SOP standardization
• Experience of effectively leading a multi-site Quality leadership team, preferable in a matrix-style organization
• Knowledge of global cGMP regulations including FDA, ISO 13485 and other Tier 1 regulatory agencies
• Provides reliable / defendable interpretations of standards and regulatory guidance and is capable of defending these positions to regulatory agencies
• Productive with a continuous improvement mind-set and disposition
• Proven eye for business, ability to operate in ambiguity, work under pressure, strong customer orientation, learning agility, within a fast-paced environment

Desired Qualifications:

• You are skilled in leading a team in a global matrix organization environment.
• Can effectively handle uncertainty and mitigate risk.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.