Senior Quality Associate with Project Management Support

Summary of Major Responsibilities

The Sr Quality Associate with Project Management Support is responsible for planning, leading, and coordinating a variety of Quality functions to support success of Corporate and Clinical Laboratory quality projects. The position will work cross-functionally to develop project plans and timelines to ensure overall goals are accomplished in alignment with business objectives.  This role will lead activities related to administering and managing Exact Sciences’ Quality System and providing support to other functions as assigned.

#LI-EL2

Essential Duties and Responsibilities

Include, but are not limited to, the following:

• Leads in administration and ensures compliance to Quality Management Systems including: Auditing, Complaints, NCMR, Deviations, CAPA, Document Control, Training (Learning Management System Administration), etc.
• Actively monitors Production and Support areas for compliance with internal SOPs and relevant regulatory (cGMP, ISO, ICH) regulations.
• Leads cross-functional project teams to accomplish project goals.
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
• Leads or collaborates with members of the Quality Assurance team working on special projects.
• Coordinates preparation activities and participates in regulatory inspections/external audits.
• Provides mentorship and training to new and existing team members.
• Consults with project sponsors and reviews project proposals to determine goals, time frame, funding, allotment of resources, and procedures for accomplishing projects.
• Identifies and schedules project deliverables, milestones, and required tasks.
• Troubleshoots problems associated with coordination, development, or design of projects. 
• Escalates issues when critical risks arise and maintains pulse with project activities to ensure progress.
• Leads direct or indirect cross-functional teams to execute on project tasks to include effective creation and management of timelines, budgets, resources, risks, and project objectives.
• Collaborates with other project and program managers to manage project interdependencies.
• Acts as a problem solver to drive decisions.
• Prepares status reports and modifies schedules and plans, as required.
• Follows established project management practices, including management of scope, requirements, issues, and risks.
• Creates MS project schedules and utilizes the schedule to communicate and manage the work.
• Manages project budgets.
• 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 work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% of a typical working day.
• Ability to work seated for approximately 75% of a typical working day. Ability to work standing for approximately 25% of a typical working day.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

• Bachelor's Degree in Science, Business Administration, Engineering, or field as outlined in the essential duties.
• 2 years of broad-based project management experience to include tracking and reporting responsibilities for a large project portfolio.
• 5 years of experience in a medical device, quality, regulatory affairs, clinical affairs, operations, or field as outlined in the essential duties.
• Demonstrated ability to balance cost, quality, and schedule constraints while escalating issues.
• Demonstrated ability to prioritize and balance multiple competing priorities within and across multiple projects at the same time.
• Demonstrated success with oral and written communications/presentations, influence and persuasion, results orientation, facilitation, and teamwork skills.
• Demonstrated ability to work in a matrix management organization with primary responsibility for project success while relying on a team of resources which may or may not be direct reports.
• Advanced proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, Project, and Visio.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 5 years of experience in medical technology.
• Strategic planning experience.
• PMI project management certification.

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. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.