The Program Manager /Controls is responsible for ensuring the success of a major, multi-year, multi-faceted and complex programs within the Quality Systems Division of Bio-Rad a global leader providing a broad array of clinical diagnostics controls to ensure laboratory measurements are within standards. As part of this ecosystem, the division also provides a growing family of software applications that help clinical laboratories worldwide to track their performance and support their efforts in accreditation which assist labs in providing accurate medical test results to physicians and patients.
This critical directly support’s the Groups 5 Year Strategic Plan and will leverage best practices in cross functional team leadership to drive excellence. Areas of excellence would incude customer requirement definition, platform and product design and development, and full commercial launch. The role will manage key timelines, cross- functional interdependencies, and lead senior level core team resources while being accountable to deliver the target scope and outcomes.
This role will have a major impact on the successful execution of the Group’s Strategy.
Leads cross-functional teams to develop new and modified products, from initiation through commercial launch, with the goal of not only delivering products of high quality and value to the organization, but also of delivering them within agreed-upon schedule, resources, budget and scope.
Acts as program champion; directs the development of bottoms-up plans and proactively manages program risks, in order to successfully deliver all program deliverables. Drive mechanisms and management techniques that ensure an open and transparent approach to the identification, communication and timely resolution of issues, risk, and challenges affecting program deliverables
Defines program resource needs and negotiate program resourcing plans. Work with functional leaders to ensure the appropriate core team resources are committed to the program and contribute to required performance levels. Establish, delegate and evaluate the roles, responsibilities, goals, deliverables and performance of core and extended team members. Prepares project contract with the Portfolio Decision Team for each phase of a project or program.
Leads the team to prepare for Phase Gate and other Go/No-Go decisions by Portfolio Decision Team, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data. Recommend ideal course of action, budget and resource allocation to deliver the program in a timely and cost-effective manner. Accurately communicate risk, impact and mitigation.
Ensures internal governance mechanisms, such as core team meetings, key technical design and commercial excellence and functional reviews are undertaken in a timely, comprehensive and effective manner. Develop a mentality of collaboration, execution and continuous improvement within the program through these mechanisms.
Ensures alignment across product value proposition, program scope, and strategic business objectives.
Leads the program planning process to ensure all requirements are clear and driven by market needs, customer insights and experience. Develop, refine and monitor progress against an accurate overall integrated platform program plan with measurable milestones and goals that form the basis of functional workstreams and deliverables.
Leads product development activity ensuring that a structured design and development process is followed, ensuring compliance with quality management systems and regulatory requirements, where applicable.
Leads as well as has a good understanding of cross-functional teams through problem resolution including root cause analysis, corrective and preventive action. Constructively challenge the team and the organization to rethink assumptions and approach headwinds in new ways. Facilitate problem solving and ultimately make the trade-off decisions across functions for optimal business outcomes.
Ensures effective formal and informal communication mechanisms with the core and extended team members using a variety of tools and channels. Build high morale and ensure the entire team commits to the target goals and objectives by creating a common purpose and direction.
Leads, directs, coachs, and mentors core team members to maximize success. Provide meaningful and regular feedback to functional leaders regarding the performance of core team members that is deployed to drive continuous improvement and the annual performance evaluation process.
Must have strong business acumen, “best for the business” perspective and demonstrate leadership, learning agility, and action orientation when facing uncertainty and instill confidence through leadership and actions.
Must have the ability to promote and leverage opinions, expertise, and perspectives to achieve best outcomes and an inclusive work environment, ensuring all interested parties have opportunities to influence and contribute to decisions and outcomes.
Bachelor's degree in science, business, engineering, or a related field. Preferably an advanced degree and/or certification in a relevant area (e.g. MBA, PhD, MS).
Program Management experience in Clinical Diagnostics or a rgulated healthcare enviornment
Experience in regulatory environment for medical device development such as FDA's Design Controls (21CFR820.30) and or ISOk
Management and Medical Device standards, ISO Software Development standards, and CLI
PMP or equivalent certification is a plus
Up 25% of travel time may be required depending on the project
12 or more years in experience in leading direct and cross functional core teams
Management experience a plus
About Bio-Rad: Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives. Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
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