Senior Manager, Quality Software

About Sequel
Sequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions. Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare.
Job Overview
The Sr. Quality Software Manager is primarily responsible for working closely with the IT & Quality teams in the oversight of Validation & Verification and other supporting activities for a large and complex Quality Management System. This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts specifically used in GMP, GLP and/or GCP processes ensuring adherence to internal procedures, industry practices and applicable regulations such as FDA 21 CFR Part 11, CFR Part 820, and ISO 13485. The Sr. Quality Software Manager will also assist and/or work with vendors to ensure systems are configured and validated properly, as needed. Additional support from administrative needs may be required.
Job Responsibilities and Essential Duties

• Responsible for supporting Software Validation and Verification efforts for the organization.
• Reports to the IT/Quality teams for all Validation & Verification team effort under their jurisdiction.
• Coordinates and communicates between Verification & Validation team and other departments and Subject Matter Experts. Partners with and/or leads Business Teams and IT to ensure that computerized Quality Processes are compliant with corporate procedures, FDA Quality System Regulations, 21 CFR Part 11 and GAMP5.
• Creates and/or oversees the creation of validation deliverables including but not limited to Validation Assessments, Validation Plans, Test Plans, IQ Protocols, PQ Protocols, Test Protocols, Test Reports, Test Scripts, Validation Summary Reports and Trace Matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment.
• Leads the review and approval of validation deliverables.
• Ensures that all validation deliverables are prepared in accordance with corporate guidelines, policies, and procedures.
• Supports Business Owners/teams and IT in the definition and creation of Business Requirements, Functional Specifications and System Specifications, as necessary.
• Communicates project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks Work with little to no supervision to fulfill duties in accordance with requirements of the QSR regulations, ISPE GAMP 5 corporate policies and procedures.
• Remains current on FDA Quality System regulations in relation to computer system validation and applies those regulations to Sequel’s Validation and Verification policies and processes.
• Supports QA department to determine document needs, establish, and improve necessary document templates, and guide staff to support project needs and maintain site compliance with good documentation practices and cGxP data integrity requirements.
• Supports other tasks as needed to enable launch as well as continuous improvement initiatives.

Minimum Requirements

• B.S. or equivalent in computer science, engineering, life science, or related field preferred.
• 5+ years of experience in software quality assurance in the life sciences industry
• Previous experience in a leadership role.

Required Knowledge, Skills and Abilities:

• Previous experience supporting computer system validation efforts including authoring computer system validation deliverables such as risk assessments, validation plans, test plans, test scripts and summary reports.
• Administrative skills and knowledge in systems including but Veeva, Salesforce and experience in supporting inspection and audits is preferred.
• Working knowledge of change management, GxPs, 21 CFR Part 11/Annex 11 and related regulations & guidance.
• Understanding of software development methodologies and concepts.
• Strong oral and written communication skills in English.
• Advanced proficiency in the use of MS Office suite.
• Working knowledge of Microsoft Project and basic project management skills.
• Strong skills at team facilitation, team organization, communication of priorities, and listening.
• Excellent interpersonal skills Open to creative, innovative, flexible, and practical approaches to improving practices and solving problems.

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.