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y Systems, this individual will serve as the business system owner and administrator for Ironwood's electronic Quality Management Systems (eQMs). Duties include daily administration of training requirements, document workflows, routine metrics and reporting for all quality processes, as well as optimization and enhancement of the systems. A member of the QSC team, responsible for providing proactive, partnership approach with key internal/external stakeholders to identify appropriate solutions that ensure innovation, productivity, continuous improvement, adherence to the applicable regulations and patient safety as per the Quality Vision while providing a true customer service experience.
Responsibilities:
Bachelor's degree in a scientific or technical discipline (or equivalent).
Minimum of 6 years' experience working in a cGMP/GXP environment.
Minimum of 3 years' experience as a Quality System Software administrator. Documentation and Training Management system administration preferred. Solabs eQMS and SumTotal LMS experience a plus.
Knowledge and experience with practical applications of risk-based approach to quality systems principles and regulatory compliance within the pharmaceutical industry.
Knowledge of applicable regulations and guidance, such as, but not limited to Food and Drug Administration (FDA) guidelines 21 CFR parts 11, 210, 211, 800, 820; Data Integrity and Compliance with Drug CGMP Guidance for Industry; FDA General Principles of Software Validation; FDA Guidance Document Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; ICH Q8, Q9, and Q10
Ability to perform gap assessments against current regulatory requirements and company standards, identify areas of regulatory risk, and then develop and implement procedural and technical improvements to address identified risks and gaps.
High level of proficiency with MS Office, including Word, Excel, Power Point, Visio, and Adobe with the ability to quickly master new programs and systems.
Demonstrated ability to perform in a highly dynamic environment to lead, coordinate and/or participate in multiple projects simultaneously, and to effectively balance changing priorities while continuing to advance progress on multiple projects.
Highly developed communication and interpersonal skills to influence, negotiate, resolve conflict and leverage alignment with key stakeholders at all levels organizationally internally and externally.
Ability to apply both oral and written skills for excellent, clear communication of technical information to non-technical users. Additionally, able to synthesize non-technical user requirements into clear and concise technical needs or specifications.
Ability to perform various tasks in a disciplined, consistent manner under minimal supervision.
Able to work remotely in an efficient and effective manner.
Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.
Ironwood currently anticipates that the initial base salary for this position could range from between $128,000 to $152,460. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.
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