Project Manager II

Job Title: Project Manager II

Location: Mansfield, MA (On-site, Monday - Friday)

Position Type: Full-time

Worksite Address

11 Cabot Boulevard, Mansfield, MA 02048

Position Overview

We are seeking a FDA Remediation Project Manager to lead our remediation efforts, with a focus on FDA audits and potential support for other upcoming audit streams. The position involves managing multiple remediation projects and collaborating with cross-functional teams to ensure timely and successful project delivery. This is an on-site role that requires strong project leadership, experience in process improvement, and the ability to navigate regulatory and compliance standards.

Key Responsibilities

• Project Leadership: Lead cross-functional project teams to deliver value stream optimization projects on time, within scope, and on budget. Manage small, independent projects or specific workstreams within larger, complex programs.
• Continuous Improvement: Apply Lean Six Sigma methodologies to streamline processes, eliminate waste, and increase productivity for assigned value streams.
• Risk Management: Identify potential risks and develop mitigation plans to proactively address issues and ensure project success.
• Stakeholder Collaboration: Work closely with teams in maintenance, engineering, manufacturing, quality assurance, product development, process technology, and supply chain to align project goals and ensure successful execution. Provide regular updates to senior management on project status, performance metrics, and improvement initiatives.
• Problem-Solving: Participate in solving challenges encountered during the project lifecycle.
• Project Planning & Coordination: Work with cross-functional teams to assign and track key project activities, ensuring clear communication of industry standards and best practices. Construct project timelines, monitor resources, and build budgets in collaboration with senior program managers.
• Performance Metrics & Change Management: Establish and monitor key performance indicators (KPIs) to track progress, measure success, and drive continuous improvement. Facilitate change management processes to ensure smooth transitions and stakeholder buy-in for process changes.
• Quality & Compliance: Ensure all projects and processes adhere to regulatory requirements and industry standards for medical devices, following Good Manufacturing Practices (GMP), Quality Systems Regulations (QSR), Standard Operating Procedures (SOPs), and Health and Safety requirements.
  
  

Qualifications

• Bachelor’s degree in Engineering, Science, Business, or a related field (Mechanical or Bio-Mechanical Engineering preferred).
• 2-5 years of project management experience, ideally within a manufacturing environment. Experience in FDA-regulated industries or medical devices is highly preferred.
• PMP certification is preferred.
• Experience leading cross-functional teams and managing projects to completion.
• Strong organizational, leadership, and communication skills with a team-focused attitude.
• Strong computer skills, including proficiency with Microsoft Office.
• Understanding and experience with Lean/Six Sigma; certification is a plus.
• Ability to work independently with minimal supervision while managing multiple projects simultaneously.
• Experience with product development processes and qualification within the medical device industry is a plus.
• Strong analytical skills and the ability to manage complex projects with a focus on continuous improvement and risk mitigation.
  
  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Job ID# 510985