The Role
This role leads QMS initiatives to enhance compliance and processes, collaborating with teams to manage projects, communicate progress, and ensure regulatory adherence.
Summary Generated by Built In
As the Project Manager, Quality & Compliance , you will be responsible for leading cross-functional initiatives for continuous maintenance and improvement of the Quality Management System (QMS), focusing on developing system-driven solutions, at Penumbra. This role involves recommending and managing improvement projects, overseeing complex initiatives to enhance existing QMS processes, and updating the QMS to maintain compliance with regulatory requirements, industry standards, and internal policies. The Project Manager, Quality & Compliance will collaborate with cross-functional leaders to drive quality initiatives, communicate project progress, implement risk mitigation strategies, and ensure the effectiveness of the Quality Management System (QMS). This role will also keep management stakeholders at Penumbra informed on key compliance efforts and continuous improvement activities.
What You’ll Work On
• 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.
What You Contribute
• 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
Working Conditions
General office environment. Willingness and ability to work on site. May have business travel from 0% - 10%. Requires some lifting and moving of up to 15 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $125,000 - $190,000
We offer a competitive compensation package plus a benefits and equity program, when applicable.
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
•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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
Top Skills
Fda 21 Cfr Part 11
Iso 13485
Mastercontrol
Microsoft Office Professional Suite
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The Company
What We Do
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant.
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