Job Information
Bausch Health Senior Quality Software Specialist in Bridgewater, New Jersey
Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.
The Computer System Assurance (CSA) engineer is responsible for Software Quality Engineering processes ensuring the development of GxP computerized systems to meet business process requirements and to meet evolving regulatory expectations and requirements. This role will partner with IT to develop and maintain the processes and procedures to support the Software Development Lifecycle (SDLC) as well as the processes and procedures needed to management and maintain GxP computerized systems. This includes providing day-to-day support to System Support Teams, reviewing and approving Change Requests, interfacing with internal and external auditors and ensuring all GxP systems are maintained in a validated state. This role will also ensure the adherence to, and continuous improvement of, our software system management processes.
Ensure the company's regulated computerized systems perform as required and are compliant by leading activities to develop, implement, and maintain a Software System management process and support its use on projects to implement, modify, and retire regulated software and associated processes.
Build a computer system support QMS with focus on GxP regulation requirements for computerized system and data integrity.
Provide leadership on project teams to assure the adequacy and compliance of Software Quality activities and to provide in-project coaching and training by example. Acts as project Quality to ensure projects are “healthy” and run well to achieve their stated goals.
Develop process and procedures required to ensure computerized systems are managed and maintained to achieve a state of computer system excellence that provide the company with advances in technology to meet changing industry needs in a risk-based and timely manner.
Leading Quality, Engineering, R&D and IT organizations to plan and prioritize their Software Quality activities and to identify their Software Quality resource needs for projects.
Plan and monitor resource allocation and loading to support multiple projects with regard to there are of expertise.
Provide expertise on Quality System process, structures and training as required in areas such as Change Management, Non-Conformance/CAPA, Auditing, Supplier Quality and Training as needed
Qualifications
Excellent communicator with strong interpersonal relationship skills.
Bachelor's degree in hard sciences or Computer Science, IT or related technical experience.
Minimum of 15 years of computer assurance/validation experience in a regulated industry.
Minimum of 5 years in a GxP life sciences industry.
Minimum of 5 years in SOX related industry.
Minimum 3 years working with SAP implementations.
Hands-on experience with Computer System Assurance in a GxP regulated environment in addition to experience.
Experience with auditing Computer and/or Software Quality Management Systems.
Experience with leading successful global multidisciplinary and multiple cultural teams, maintaining schedules, dealing with resource constraints, providing guidance, and with identifying and recommending changes to established practices.
Experience with remote teams.
Demonstrated ability to be self-motivated and a strong technical leader/mentor that persistently follows-through on projects, strong written and oral communication and interpersonal skills.
Experience with implementation and completion of remediation plans for regulatory findings.
Significant experience in SAP (multiple projects) and other ERP and financial systems as well as SOX regulations.
As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $95k - $115k.
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
#LI-remote
This position may be available in the following location(s): [[location_obj]]
We thank you in advance for your interest in growing and developing with our company. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.
Any exception will have to be authorized by your HR Business Partner.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.
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Bausch Health is an EEO/AA employer M/F/D/V.