Job details
Job type full-time
Full job description
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forwardJoin a team where you can be heard, be supported, and always be yourselfWe’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associatesLook again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman coulter diagnostics is proud to work alongside a community of six fellow diagnostics companies at danaherTogether, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The director, quality and regulatory affairs chemical and immunoassay for beckman coulter diagnostics will report to the ccia vice president quality assurance and regulatory affairs and will be hybrid to chaska, mn or a remote role.
In this role, you will have the opportunity to:
The director, quality and regulatory affairs combines knowledge of scientific, quality, regulatory and business issues to enable products that are developed, manufactured, or distributed to meet required standards and legislation in all marketed countriesThe individual will direct, develop, and supervise quality and regulatory professionals with business unit level influence and is generally considered a key opinion leader and an expert resource within beckman coulter and externally to other danaher operating companies (opco’s)The individual may interface with outside regulatory agencies and trade associations and provide executive management with regulatory and quality metrics/informationThe individual will plan, budget, direct, coordinate and control the quality and regulatory affairs activities for our quality and regulatory teams located in chaska, minnesota, and brea, california.
Principal responsibilities:
Provides leadership and direction through managers of the quality and regulatory teams located in in chaska, brea, and carlsbad qra groups positioned globallyIs accountable for the performance and results of these teams.
Leads and manages the qra teams within chemistry/immunoassay and across beckman business units to realize the qra missionCollaborates with a broad base of internal groups to efficiently monitor, measure, drive continuous improvements to meet or exceed customer expectationsDrives global strategies to continue to enhance qra processes in compliance and efficiency.
Provides leadership to global internal business unit leaders and functions, influence to drive continuous improvement, best practice sharing and harmonization world-wide.
Drives excellence by strengthening people skills, efficient methods, and engagement to assure optimal execution of strategies, achievement of product plans and continuous improvement in methodologies and processes.
Executes business plans as required and contributes to the development of company and functional strategy and may work through other assignments according to business needDecisions are guided by functional operational strategy and priorities.
Directs and facilitate teams of quality and regulatory affairs professionals to support global product registrations for products and products where geo is identified or has responsibility as manufacturer (lm) or authorized representative.
Implementation of quality system and qms improvements to ensure compliance
Fda quality system requirement (usa),gmp for ivd reagents (china), ivd directive (europe), therapeutic goods act 1989 and therapeutic goods (medical devices) regulation 2002 tg(md)r sch3 (australia) , cmdr sor/98-282 (canada),national health surveillance agency rdc anvisa 16/2013 (brazil), pmd act (japan),mdsap (combined program for the regulations of usa/australia/brazil/canada/japan) as well as other supplied geography regulatory requirements, and iso 13485:2016 with mdsap.
Maintain a strong on-going knowledge via reading as well as classroom training where appropriate of latest agency regulatory requirements (e.gUs fda, china fda, health canada, hpra guidance’s, tga, anvisa, ivdd) and applicable standard requirements (e.gIso 13485).
Establishment of objectives for quality and ra at beckman– tracking and reporting on the organizations performance against these objectives.
May serve as management representative– the management representative has established authority over and responsibility for: 1) ensuring that applicable quality system requirements are effectively established and effectively maintained2) reporting on the performance of the quality system to management with executive responsibility for review.
Must be a collaborative facilitator and leader, building consensus while championing global quality and regulatory initiatives that focus on speed to marketProviding direction regarding quality and regulatory practices ensuring the development and implementation of advanced and aggressive strategies that provide a competitive edge to beckman coulter.
Lead preparations and/or negotiations with the global regulatory agencies or authorities through the submission processes.
Ensure business teams consider the impact of current or emerging quality and regulatory issues, works with management from all sites to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
Ensure post-market product compliance, demonstrated by timely, consistent review of adverse events and recall notification within statutory guidelines, minimizing the risk of fda actions that could impact our business.
Through subordinate managers of managers contributes to the development of long-term strategy to build and develop a high performing quality and regulatory affairs teams.
Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.
Utilize danaher business system (dbs) tools to drive compliance and effective processes; developing quality and regulatory metrics and scorecards and institute data-based process improvements which will align with corporate and business unit goals.
Applies broad industry knowledge and commercial awareness to drive financial and operational performance across the businessDevelops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations.
Acquire, develop, and retain top talent in qra functions by developing and maintain a technically excellent high performing team.
Align the functional group around shared goalsOptimize the group’s workIncrease partner understanding of the group’s roles, responsibilities, and value propositions.
Establish functional group training requirementsIdentify and enable targeted training to improve functional skills and address individual developmental needsProvide active mentorship and functional support to ensure employee and project success.
Regularly assess and actively manage individual and group performance; engage in the creation and implementation of employee development plans.
Recognize and reward achievement, commitment and excellence in the advancement of organizational, departmental and group strategies.
Provide staffing, resource allocation and work direction to effectively and efficiently achieve portfolio, project/functional goals and objectives.
Participate in department budgetary planning and forecasting; identify and communicate group budgetary needs and constraints; and ensure group performance to budgetary plan.
The essential requirements of the job include:
A bachelor’s or master’s degree preferably in areas of life sciences, engineering, or quality assurance with minimum 20+ years of experience or master’s degree in field with minimum 18+ years of experience or doctoral degree in field with minimum 9+ years of experience.
Minimum 5 years in a qa functional role with 6 years accumulated manager level experience in career background.
Completion of basic manager training course (e.g“leadership essentials” or similar such as situational leadership, mosaic, or kepner-tregoe training).
When you join us, you’ll also be joining danaher’s global organization, where 69,000 people wake up every day determined to help our customers winAs an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful danaher business system tools and the stability of a tested organization.
