ThermoFisher is looking for a Quality Assurance and Regulatory Affairs Manager for its Kalamazoo area operation.
Job description
The Quality Assurance and Regulatory Affairs Manager will manage a team and be responsible for driving Quality & Regulatory compliance initiatives while aligning with organization leaders to meet business needs.
Key Responsibilities:
• Act as a leader in the Quality & Regulatory function by designing and implementing Quality systems and advising the Site Leader/SLT on Quality & Regulatory standards applicable to the business being served.
• Manage the Quality and Regulatory function for the Kalamazoo site, leading the QARA team to drive the goals of the business.
• Ensure the business remains compliant with local, federal and global quality system regulations applicable to the products manufactured, sourced by, distributed and installed/serviced by the Kalamazoo site.
• Leverages knowledge and expertise of Quality team members to remain focused on high-value work.
• Implement and oversee CAPA (Corrective and Preventative Actions), validations, inspections, document control, regulatory affairs, and problem resolution, acting as an advisor.
• Manage customer quality/regulatory compliance inquiries and visits when escalated to ensure a satisfactory resolution is achieved.
• Act as the primary interface with external Quality Auditors and Regulatory Agencies during on-site audits and follow-ups.
• Act as the Quality Management Representative for the site, fulfilling the requirements of ISO13485.
• Working with the R&D and other functions, ensure that design and change control systems are effective, and provide QA review and oversight to design change/New Product Development projects.
• Establish and maintain regulatory files to support the regulatory compliance of product manufactured at and for the Kalamazoo site, including CE Technical Files (per European IVD Directive) and 510(k) per US FDA requirements.
• Review and approve product labeling / product marketing literature for regulatory compliance and claims support.
• Coordinate and provide relevant documentation to Regulatory Agencies and/or Thermo Fisher Regulatory Affairs colleagues, to enable timely product registrations.
• Lead product vigilance/MDR reporting requirements for the site and coordinate responses to FDA for any Field Safety Corrective Actions. This includes product imported by the Kalamazoo site for distribution with USA/Americas.
• Act as a key member of the Kalamazoo site management team, promoting quality/regulatory awareness and support of site and business objectives.
• Managerial responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Build and manage annual budgets for the QARA department working in conjunction with the Site Leader.
Desired Skills and Experience
Minimum Requirements/Qualifications:
• Bachelor’s degree in a Scientific/Engineering discipline or equivalent experience.
• Excellent knowledge of cGMPs guidelines, 21 CFR Parts 820, 803, 806, ISO13485, EU IVDD and other applicable global regulatory standards.
• Minimum 5 years of experience in the medical device or pharmaceutical industry.
• Minimum of 5 years of experience in a supervisory position.
• Project management experience.
• Must have excellent interpersonal skills and communication skills, written and oral, in English.
• Ability to handle conflict with confidence and integrity.
• Sound organizational skills.
• Must be able to multi-task and evaluate self/team priorities effectively.
• Attention to detail.
• 5 percent travel: domestic and international.
Bonus Qualifications (not explicitly required):
• Total Quality Management / Lean / 6 sigma experience
• Lead Auditor experience/qualifications
• ASQ Certification or equivalent
• A second business degree/qualifications
About Thermo Fisher
Thermo Fisher Scientific is the world leader in serving science. The company's mission is to enable customers to make the world healthier, cleaner and safer. With revenues of $13 billion, Thermo Fisher has approximately 39,000 employees and serves customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries.
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