Associate Director, Product Support & Operational Excellence

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At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Associate Director, Product Support and Operational Excellence will lead multiple technical teams responsible for ensuring product availability and also manage and execute operational excellence initiatives within Operations and other groups, as needed. This role will oversee complex technical issue resolution, process and product improvement, risk mitigation activities, and support new product introduction working closely with Technical Services, R&D, Quality, Regulatory, Clinical Laboratory and Operations teams to deliver on critical business objectives. This role will also lead implementation of continuous improvement projects in operations and drive organizational change to enhance efficiency, productivity, and quality.

Product Support Essential Duties

Include, but are not limited to, the following:

• Lead Managers of Product Support teams driving initiatives that align with business needs.
• Establish, implement, and/or improve enterprise-wide product support processes to ensure sustained delivery of high-quality reagents to clinical lab customers.
• Oversee activities related to troubleshooting of manufacturing processes and test methods for materials such as oligonucleotides, enzymes, antibodies, and molecular biology reagents used in complex molecular diagnostics products utilizing polymerase chain reaction (PCR) and next generation sequencing (NGS)-based technologies.
• Manage and guide product support teams resolving Out of Specification events (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Lead and support investigations into customer complaints in collaboration with Technical Services.
• Provide strategic and technical leadership in the evaluation of new sources of raw materials to reduce supply risk and achieve business profitability goals.
• Interact with vendors to resolve challenges with raw materials or established processes and/or develop new processes to implement with our strategic partners to improve reliability of incoming materials. This work is done in collaboration with internal stakeholders in Supply Chain and Quality Engineering.
• Prioritize a portfolio of support and improvement projects based on mid- and long-term business objectives, changing functional needs, resource capacity constraints, risk exposure, and ensuring clarity in project interdependencies.
• Oversee design and execution of complex studies and designed experiments using appropriate statistical techniques.
• Provide thought leadership in design for manufacturability for future products and test methods in collaboration with R&D.

Operational Excellence Essential Duties:

• Plan, manage, and execute operational excellence programs and projects.
• Identify opportunities for process improvements and lead continuous improvement initiatives within Operations and across the enterprise, as needed.
• Utilize methodologies such as Lean, Six Sigma, and Kaizen to drive efficiency and effectiveness.
• Train and mentor employees on continuous improvement tools and techniques.
• Develop and implement change management strategies to support the adoption of new processes and technologies.
• Foster a culture of continuous improvement and innovation within the organization.
• Leverage Operational Excellence skills to address complex cross-functional initiatives or obstacles.

Leadership and General Essential Duties:

• Oversee the leadership and management of multiple technical teams supporting several programs or technology areas to identify problems and improve processes.
• Mentor and develop next level managers and leaders to continue to grow talent within our organization.
• Remove barriers and obstacles encountered by teams to enable timely and on-budget completion of programs and projects.
• Establish annual operating plans and budgets for product support teams.
• Establish and align group goals with the organization's broader strategic objectives. Hold teams accountable to business and department objectives.
• Collaborate with senior leaders across functions to ensure alignment and coordination on strategic initiatives.
• Influence and negotiate with key stakeholders to drive organizational directives.
• Lead and manage several varied projects at one time, with frequent changing priorities.
• Motivate and inspire leaders and front-line employees to do their best work through coaching.
• Maintain morale and support employee engagement initiatives.
• Communicate to all levels within the company in a fast-paced, everchanging environment.
• Make decisions with limited information and operate with autonomy.
• Ability to organize, present, and convey complex problems or issues within and across other functions.
• Ability to effectively work on many complex and varied projects at one time, with frequently changing priorities.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Molecular Biology, or closely related scientific field.
• 15+ years of industry experience with biochemical and molecular based products.
• 6+ years of people leadership experience.
• Proven experience in program management, operational excellence, and change management.
• Professional working knowledge of Lean, Six Sigma, and other continuous improvement methodologies.
• Proficiency in data analysis and performance measurement tools.
• Professional working knowledge in Microsoft Office.
• Professional working knowledge with 21 CFR Part 820, ISO 13485, and/or cGMP structured environments.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Advanced degree (MS or PhD) in Biology, Chemistry, Biochemistry, or Molecular Biology.
• Lean Six Sigma Green Belt, Black Belt, or Sensei/Leader
• 10+ years of experience with Medical Device Products in a Product Development, Product Support, or Manufacturing Sciences role.
• 7+ years of experience with Project Management principles and practice.
• 2+ years of experience working within Enterprise Resource Planning (ERP) systems such as SAP.
• Professional working knowledge in statistical and mathematical methods in biology/genetics, including experience with JMP software.

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Salary Range:
$152,000.00 - $242,000.00

The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

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