We are a global team of 6000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.
The Software Quality Assurance Manager will provide quality assurance oversight throughout the development lifecycle of Edgewell software solutions in ensuring that the solutions and supporting infrastructure are always delivered and maintained in compliance with the applicable regulatory and internal standards. The ideal candidate is expected to demonstrate effective leadership experiences in managing Software Quality Assurance resources across multiple teams, solutions and platforms.
Lead Software QA projects and initiatives, including communication of progress to cross functional and management stakeholders
Execution of governing CVS policies/procedures.
Act as an SME in providing guidance to the business on regulatory and internal standards throughout the systems developmental lifecycle.
Management of the quality assurance team in establishing priorities for the quality review of validation artifacts and deliverables.
Actively partner with the End Users, IT and Validation Manager in the selection process of all new Solutions introduced at Edgewell, engaging the projects at an early stage of the process to ensure CSV compliance and that the solution of choice is fit for use and purpose.
Provide Quality Assurance oversight of CSV protocols, change request reviews for enterprise-level, manufacturing and laboratory systems.
Provide the assurance that computer systems & CSV processes are compliant & meet regulatory & business requirements.
Work with the business, IT and Validation Manager to find solutions for the remediation of identified CSV compliance gaps through the appropriate investigative, corrective and preventive mechanisms.
Support regulatory and internal inspections for impacted systems supporting Edgewell's Quality Management System.
Work with IT, and the business to ensure alignment in execution of validation activities to achieve and agreed upon state of control for computer systems and infrastructure
Participate and assist in post release periodic reviews, maintenance and support activities
Participate and assist in various Software Defects, Complaints Handling, CAPA, Safety Classification and Risk Management activities to ensure software quality is maintained.
Required Education, Skills and Experience
Bachelor's degree in engineering, science
5-10 years' experience in Software quality within the Healthcare, Pharmaceutical or Medical device industry
3-5 years leadership both in developing high performing teams but also leading projects
Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.
Knowledgeable of FDA regulations regarding the Validation Life Cycle and the Software Development Life Cycle. (21 CFR Part 11, Annex 11, 21 CFR Parts 210/211, ISO 13485 and GAMP 5)
Excellent communication, analytical reasoning, decision making and problem-solving skills desired
Ability to partner with individuals and teams, build cross functional relationships and demonstrate boundary less commitment
Experience in the validation of cloud base enterprise systems.
Knowledge of quality business practices and business development.
Excellent multi-tasking, analytical, organizational and leadership skills
Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.
Edgewell Personal Care