Hello,
If you are looking for a Business related Job ? Then, This is the place where you can find All sources of Job opportunities with detailed information.
| Job Category : | Business |
| Company Name: | RTI Surgical Inc |
| Position Name: | IT Manager, Compliance |
| Location : | Alachua, FL 32615 |
| Job Description : | Job Title: IT Manager, Compliance Department: Information Technology Effective Date: 2/3/2022 Location: Alachua, FL While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments). SUMMARY: RTI Surgical is a global, industry-leading private label OEM with expertise in allograft, xenograft, and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients. As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic & reconstructive surgery, urology/urogynecology, and trauma. RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values: We are accountable to each other by trusting each other’s judgment and holding each other responsible for results. We find joy by striving to create a working environment that people enjoy. We fully engage by focusing our hearts and minds on our customers, patients, and each other. We adapt to change by working collaboratively to be flexible to the changing needs of our business. RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in Greenville, N.C., and Germany. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential. POSITION SUMMARY: The Compliance Manager is responsible for the overall system validation of all RTI existing and upcoming IT systems. The ideal candidate will have demonstrable knowledge of design and implementation of validation procedures, test plans, and test cases, 21 CFR Part 11 requirements, and the ability to coach and persuade cross-functional teams. The candidate should have ideally worked with pharmaceutical, healthcare, or medical device manufacturer on ensuring validation services. The ideal candidate will be responsible for ensuring a successful annual Audit with zero major findings, working directly with Auditors to IT, Quality, and Operations teams to scope & execute projects. Additionally, the candidate should demonstrate high degrees of competency in analysis, documentation & project management. The candidate should be able to develop, write and manage the execution of an overall software test strategy, lead efforts to enhance and make the testing process more efficient. The candidate should have ideally worked with pharmaceutical, healthcare, or medical device manufacturer on ensuring validation services. The ideal candidate will be responsible for ensuring a successful annual Audit with zero major findings, working directly with Auditors to IT, Quality, and Operations teams to scope & execute projects, managing deviations, discrepancies, and changing control documents. RESPONSIBILITIES: Assists with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met Coaches the implementation teams, in the proper execution of validation documents Evaluates proposed changes to validated computer systems and recommend the level of validation activities required Coordinates audit of internal computer systems validation activities, protocol, and procedures, and prepare responses Identifies and qualifies all computer systems which impact cGMP operations using a risk-based methodology Develops CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ/PQ protocols, all documents, and deliverables within the scope of the validation plan Develops and maintain test plans, test scripts, and user acceptance tests and manage the execution of test plans Acts as a CSV Lead for all validation projects Executes or oversee the execution of validation plans and validation documents Performs project management activities for CSV process within the scope of an overall system project Works with the overall project manager to include validation activities in implementation timelines Manages internal CSV resources to facilitate completion of qualification activities Ensures initiation/preparation and closeout of all CSV-related deviations, discrepancies, and change control documents. Works closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems Conducts or facilitates validation and 21 CFR Part 11 training EDUCATION/EXPERIENCE REQUIRED: Bachelor’s degree in computer science, engineering, life science, or related field 8+ years experience with CSV validation lifecycle management, validation documentation development and 3+ years of project management, using a risk-based methodology Minimum 2 years in Pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc. Excellent interpersonal, communication, organizational, and project management skills. Excellent presentation and writing skills. Supervisory/leadership experience preferred Physical Requirements: Light work: Physically handle objects up to 20 lbs. occasionally. Work Environment: Office Setting – Open layout with an assigned work station or office |
Hope, the above sources help you with the information related to Business Job. If not, reach through the comment section.