Manager of Digital Systems Quality and Compliance

As a Manager of Digital Systems Quality and Compliance, you will play a pivotal role at Penumbra serving as the Business Owner of an entire Enterprise Quality Management System (EQMS).
You would also be primarily responsible for ensuring the compliant implementation, validation, ongoing use, enhancements, support, and maintenance, and decommissioning of the system to support Penumbra’s quality management systems.
You will aligns the overall responsibility for the system and data with the business process owners, who are responsible for executing the process and creating the data, and with the system owners, who are responsible for the design, implementation, and ongoing compliant system administration and technical support.
What You’ll Work On • Select, manage, train, and develop staff.
Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.
• Coordinate internal/external resources for system implementation, qualification, validation, training, and ongoing licensing, maintenance, and support of the system.
o Supervise/facilitate Compliance Engineers to build a culture of compliance in partnership with IT - Software Quality.
o Support Compliance Engineers on CSV activities for all GxP systems.
o Develop and maintain user requirements, SOPs, and Business Continuity Plans.
o Approve applicable CSV documentation per the Computerized System Validation Plan.
• Ensure the ongoing validation state of the EQMS by managing IT change control, system requalification, and SOP maintenance, as well as facilitating scheduled periodic system reviews, user access reviews, audit trail reviews, and the resolution of any resulting system incidents, supplier corrective actions, deviations, and CAPAs.
• Collaborate with IT to manage the internal backlog of work, external backlog of work, and any external facing customer portal.
• Manage vendor relationships such as supporting monthly CSM calls, license management, coordinating calls with support.
• Assess current QMS business process/applications and make overall recommendation for updates based on industry trends, business needs and professional business/technical knowledge.
• Ability to make business and process decisions, in line with the goals defined by business process owner(s), regarding the system with detailed understanding of the system, its purpose, functions, and use.
• Ensure the ongoing training of system administrators and users.
• Improve training and operational procedures to increase efficiency and productivity.
• Facilitate support from executive management, internal stakeholders, and SMEs.
• Create and present reports to executive management and stakeholders to support recommendations.
What You Contribute • A Bachelor’s degree with 8+ years of related experience in the fields of quality, biomedical, life/physical sciences, engineering, or equivalent combination of education and experience.
• Project management skills required.
• Understanding of domestic and international regulations and standards including FDA QSR/QMSR, EU MDR, and ISO 13485:2016 required.
• Understanding of computerized systems validation (CSV) required.
• Experience working with a variety of quality and process improvement tools required.
• Medical device, pharmaceutical, biotech, or other regulated industry experience desired.
• Demonstrated ability to work cross-functionally to solve problems and drive projects to completion.
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.
• Excellent oral, written, and interpersonal communication skills.
• Excellent analytical and decision-making ability and leadership skills.
• Technical writing proficiency (e.
g.
, SOPs, Work Instructions, ECOs, protocols, analytical reports).
• High degree of accuracy and attention to detail.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project.
Working Conditions General office environment or hybrid.
Willingness and ability to work on site as needed.
May have business travel from 0% - 10%.
Potential exposure to blood-borne pathogens.
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: $135,000 - $200,000 / year 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 Penumbra's AAP Policy Statement.