The Sr Business Systems Analyst will assure that validated computerized systems are implemented, maintained, and obsoleted in a state of compliance. Assess the performance of regulated systems. Lead, drive and own projects and ensure effective communications and cross collaborations with the business on various Computerized Systems Validation initiatives and projects. Any communications or cross collaborations with the business are to be done by Level III and above. The Sr level will also work closely with the Manager to assist with training and mentoring more junior level CSVS and Business Analyst.
What You’ll Work On
- Work closely with management to support other quality engineering initiatives to drive them down throughout the team.
- Work on multiple projects and meet timelines, requiring expert multitasking skills and ability to prioritize work effectively.
- Create documentation to support the design and development of solutions, such as, but not limited to, user stories, business/product requirements documents (BRD/PRD), functional and non-functional specifications and documentation (FRD), acceptance criteria, product roadmaps, and to-be process flows and traceability matrices, meeting notes, gap analysis, etc.
- Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
- Manage and execute the deviation process during execution of testing. Author deviation form content. Work with the customer to resolve deviations recorded during test execution or system modifications.
- Apply knowledge of quality engineering principles to ensure compliance with regulatory requirements and impart that knowledge to junior level CSVS.
- Work closely with the SWQ Manager to collaborate with cross functional team to identify, prioritize and execute business critical quality initiatives.
- Ensure other members of the department follow the QMS, regulations, standards, and procedures.
- Manage conflict resolutions both transparently and proactively by continually informing manager, team, and client of progress, issues, and concerns.
- Work with end-users across the organization, to gather, understand, prioritize, and define business requirements, leveraging Medical Device, Pharmaceutical experience and best-practice methods and collaborating and seeking guidance from stakeholders.
- Provide quality support to development, engineering and manufacturing functions for design control and transfer activities.
- Facilitate and participate in internal development team’s quality reviews of requirements to ensure they are complete, consistent, comprehensible, feasible, and conform to standards and align with client business objectives.
- Drive/assist the development of business strategies, as appropriate, to guide clients and inform requirements.
What You’ll Bring
- Bachelor’s degree required, in engineering, computer science, or related discipline with 12+ years related experience, preferably in the medical device, pharmaceutical, or similar FDA-regulated industry, or an equivalent combination of education and experience.
- Required to have advanced knowledge of Quality Engineering Principals and Regulatory Environment such as: 21CFR11, 21CFR820, Annex 11, ISO 13485, 21CFR210, 21CFR212, HIPAA/PHI, SOX, GDPR
- Experience with the installation, configuration, validation, and maintenance of regulated software such as Quality Management Systems, Learning Management Systems, and Clinical Trial Management Systems
- Expert knowledge of GAMP guidelines, 21 CFR Part 11, and FDA requirements and expectations for validated systems preferred.
- Strong oral, written and interpersonal communication skills.
- Strong leadership skills with ability to work effectively within a cross-functional team.
- Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.
Working Conditions
- General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
- Alameda, CA
- Starting Base Salary is $132,430/year - $188,053/year.
- Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift.
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.
