Hybrid Project Manager, Quality & Compliance

at Penumbra, Inc.

• Job title: Project Manager, Quality & Compliance
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $125,000 - $190,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Alameda, United States

About the role

• Project Manager leading cross-functional initiatives for Quality Management System at Penumbra. Collaborating to drive improvements in compliance and quality processes.

Responsibilities

• 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.

Requirements

• A Bachelor's degree, preferably in life sciences or engineering with 5+ years of quality management systems experience in a regulated medical device or pharmaceutical environment, or an equivalent combination of education and or demonstrated experience.
• Proven experience with eQMS platforms, such as MasterControl
• Ability to manage multiple, complex priorities within demanding timeframes with precision and accuracy
• Experience designing and implementing continuous improvement initiatives aligned with regulatory and business needs
• Proven ability to influence stakeholders and drive adoption of new ideas and processes
• Medical device, pharmaceutical, biotech, or other regulated industry experience desired
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with Microsoft Office Professional Suite (Word, Excel, and PowerPoint)
• Knowledge of QMS standards and regulatory environments (e.g. ISO 13485, FDA 21 CFR Part 11)
• Strong technical aptitude and ability to quickly learn new systems and tools
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
• Exercises judgement based on policies and management guidance to determine appropriate action

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an 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, and paid sick time in compliance with applicable law(s).