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Hybrid Project Manager, Quality & Compliance

at Penumbra, Inc.
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About the role

  • 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).

Job title

Project Manager, Quality & Compliance

Job type

Full Time

Experience level

Mid levelSenior

Salary

$125,000 - $190,000 per year

Degree requirement

Bachelor's Degree

Location requirements

HybridAlamedaUnited States

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