Sr. Manager, Site Quality and Regulatory Affairs

Invitrogen is seeking an experienced Quality Assurance/Systems Manager for Milwaukee, Wisconsin.Position Objective:This position provides and champions strong day-to-day Quality Systems leadership and quality improvement support for the Transplant Diagnostics business unit with sites located in Brown Deer, Wisconsin and Bromborough, England. Serving as the Site Management Representative, the incumbent will lead all types of regulatory and ISO quality inspections to successful outcomes. The incumbent will also serve as a member of the Global Quality/Regulatory team.This position will have dual reporting, direct line to Global QA/RA and matrix reporting to site Operations.Critical To Quality (CTQ’s) and Essential Functions:• Perform, develop, and execute strategies to meet wide-ranging Quality, Regulatory, and Compliance evaluation.• Lead, manage and develop Quality groups through a period of rapid change. Tight communications, operating and aligning within a matrix, removing silos, improving productivity and efficiency, standardizing and harmonizing processes and systems are all key to success.• Identify and develop a partnership with critical external customers by understanding and meeting their requirements, proactively communicating and delivering reliable and high quality products in a timely manner.• Be willing to initiate and lead Continuous Improvement Projects following Company’s Functional Excellence tool like (GB, Six Sigma, 5S)Educational Requirements:A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science preferred but not required. M.S. or M.B.A. is a plus. Experience Requirements:• Must have a minimum of 8-10 years hands-on experience in Quality Assurance, with heavy emphasize in Quality Systems and Compliance, and a minimum of 5 years at a management level (Manager) leading a Quality Assurance group in a GMP/ISO regulated industry such as devices and diagnostics. Quality Engineering experience and or certification is a plus.• Experience in a GMP environment or strong ISO 13485 Quality Systems experience• Understanding of US and EU regulationsExperience Plus:• Multi-site experience in a mid to large size company• Experience in building global systems • Experience with common continuous improvement tools a plus (e.g., six sigma, SPC)Desired Profile:• Demonstrated leadership skills and experience in managing change, influencing outside of his/her area of responsibility, attracting/developing talent, and coupling high performance standards with appropriate soft skills • High energy level; positive attitude; works well under stress• Strong communicator • Balance of strategic thinking, analytical skill and ability to execute• Hands-on, action-oriented, and able to implement effectively through his/her team• Continuous improvement minded; used to balancing the need for Quality and the need for efficiency• Able to work autonomously in a matrix-managed organization• Willingness to travel (~10-15%)• Courageously faces reality and can provide opinions and solutions in face of adversity; decisive and able to provide clear guidance to the organization in the absence of conclusive data or of clear guidance from the regulators• Comfortable with ambiguity and change• Track-record of working collaboratively with Manufacturing and Operations, so that quality becomes everyone’s job. In particular, should avoid the development of an “us versus them� relationship between Quality and Operations.• Cultural fit with Invitrogen culture: “down to earth� personality, approachable, friendly with people at all levels and in all cultures, informal, unquestioned integrity, honest, and a good sense of humor; hard-working and intense; open, collaborative management style that fosters the development of key talent and leaders• High level of competence on matters of Compliance and regulatory affairs; has experience in these areas at a senior level; strong technical background. • Good business sense for what’s practical, and what’s not, what’s needed for what parts of the business. Good sense for Operations in general. Able to effectively operate in a cost-conscious environment.