QC Apps Lab Systems Manager
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
The GxP Laboratory Instruments Manager in the Information Management department at BioMarin Pharmaceutical Inc. will provide the application and implementation support for GxP laboratory instruments. The GxP Laboratory Instruments Manager will ensure that systems are implemented efficiently following a standard process so labs are delivered systems that enhance compliance, improve efficiency, reduce regulatory risk, and meets the expectations of the key business stakeholders.
- Coordinate projects and manage deliverables across multiple departments (QA, QC, IM etc.).
- Organize project meetings and perform standard meeting organizer duties (agenda, minutes action items etc.)
- Research system/software functionality for COTS systems to determine suitability and capability of meeting user requirements
- Configure software using the standard ‘out of the box’ interface
- Draft SDLC documents including FRS, CS, UAT and Test Cases
- Draft SOPs, work instructions, and other training materials
- Document and communicate project outcomes (Positive/Negative) to management and participate in efforts to improve the process
- Educate System Owner regarding compliant software and business process choices that ensure data integrity is maintained
- Assist in ad-hoc projects as needed to address deviation investigations or initiatives
- Perform Post-Go live system/application support
- Defend systems as SME during audits
- Manage and mentor a highly motivated team of Application Specialist and contractors.
- Goal setting and performance monitoring/tracking
- Coaching, counseling and employee development
- Facilitate and nurture a quality culture that puts our patient’s safety and product quality first
- Lead and mentor on best practices regarding data integrity, corporate data management and quality software development
- Ability to plan and prioritize assignments effectively to meet timeline commitments
- 8 years in a regulated industry (preferably Pharmaceutical/Biotech, Medical Devices or Healthcare industries)
- Strong interpersonal communication skills including, formal presentations, meeting management, negotiation/persuasion and conflict resolution
- Self-motivation, and be a quick learner of business processes and technology
- Managing Personnel for performance.
- Experience implementing, administering, or supporting common software solutions used in a GxP lab (SoftMax Pro, Empower, WinKQCL, etc.)
- 2 years bench level laboratory experience
- 5 years direct experience implementing/validating software in a regulated environment
- Experience leading Risk Assessment activities and mitigating data integrity vulnerabilities
- Experience as a Project Manager or Project coordinator with knowledge of Agile, SCRUM, and traditional Project Management methodologies
- Experience in generating SDLC deliverables particularly URS, FRS and Config Spec
- Experience/Knowledge of good requirements gathering techniques including process mapping techniques. (LEAN, SIX SIGMA)
- Experience in standard software development methodologies (Rapid, Waterfall, etc.)
- Experience initiating and managing Change Control, and Deviations requests with TrackWise
- Experience with HP ALM or equivalent software testing/requirements tools
- ASQ, PMI, ITIL certifications
- Minimum: BA/BS degree in either Lifesciences (Microbiology, Biology, Biochem, Analytical Chemistry etc.) or Computer Science/MIS related degrees ~ Or a minimum of 8 years direct experience in a similar role with escalating levels of responsibility will be considered
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.