The Project Manager, Quality & Compliance will lead cross-functional initiatives for continuous maintenance and improvement of the Quality Management System (QMS), recommending and managing improvement projects, overseeing complex initiatives, and updating the QMS to maintain compliance with regulatory requirements, industry standards, and internal policies.
Requirements
- Evaluate and proactively identify updates needed within the existing QMS processes, policies, and procedures to meet evolving regulatory requirements and business needs.
- Partner with business stakeholders to identify process challenges and develop solutions, including eQMS driven solutions.
- Collaborate with stakeholders to gather critical information for prioritizing project requests.
- Resolve ambiguous requirements through structured discussions, and translate them into clear, comprehensive business requirements document, aligned with stakeholder objectives.
- Partner with cross-functional teams and act as a driver for collaboration, ensuring alignment across departments and fostering a cooperative environment to achieve project goals.
- Establish clear roles and responsibilities with cross-functional team members to promote accountability, streamline workflows, and ensure successful project execution.
- Design and document process workflows that align with regulatory requirements and business objectives.
- Lead cross-functional efforts with Subject Matter Experts (SMEs) to assess, revise, and implement quality processes and procedures.
- Design and manage complex project plans, setting strategic milestones, allocating resources, deliverables, and compliance activities to meet stakeholder expectations.
- Independently lead and manage QMS improvement initiatives from concept through execution, ensuring successful project delivery that aligns with regulatory compliance requirements, internal policies, and industry standards.
- Maintain oversight to ensure all projects adhere to relevant regulations, internal quality policies, and standards throughout all project phases, mitigating compliance risk.
- Serve as a key contributor to audit readiness, prepare for, and participate in external audits by regulatory authorities.
- Establish clear communication channels for reporting project status, to ensure visibility of project progress, risks, and key decisions to both the project team and management.
- Influence stakeholders through data-driven insights and compliance knowledge expertise, to ensure project alignment, resolution of compliance gaps, and seamless execution.
Benefits
- Medical, dental, vision, life, AD&D, short and long-term disability insurance
- 401(k) with employer match
- Employee stock purchase plan
- Paid parental leave
- Eleven paid company holidays per year
- A minimum of fifteen days of accrued vacation per year, which increases with tenure
- Paid sick time in compliance with applicable law(s)
