Manager, Quality Systems & Compliance

 

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Position summary:

Reporting to the Head of Compliance and Quality 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:

• • Act as administrator for Solabs QMS and SumTotal LMS; performing change risks assessments, managing system performance, and ensuring alignment with regulatory and internal compliance requirements.
  • Coordinate with internal and external stakeholders to modify and maintain the eQMS (Solabs QM10) that includes modules for Document Management, Out-of-Specification (OOS), Deviation, Change Control, Corrective and Preventative Actions (CAPA), Product Complaints, and Audits.
  • Act as the Document Control Coordinator; enabling timely and accurate development, deployment, and maintenance of controlled documentation through the Document Change Control Process.
  • Provide support for the Training Coordinator, enabling timely and accurate identification, assignment and maintenance of training requirements with the system.
  • Generate and communicate applicable system metrics and reports, fulfilling schedules and ad-hoc requests, for users, managers, and Quality Compliance Committee (QCC) or similar governance bodies.
  • Identify, generate and deliver education, tools, and tips to support and enhance user acceptance. Train system users in the use of software-based processes, procedures and best practices.
  • Provide general audit and regulatory inspection support as part of Ironwood’s Inspection Team. Additionally, support GxP Audits, Inspections, and Periodic System Reviews as a system SME and providing necessary Quality System reports to fulfill requests.
  • Maintain current knowledge of and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory, GxP requirements and related policies and procedures.  Advocates for full legal compliance and ethical conduct in all business transactions.  

  Requirements:

  • 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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Last updated on Aug 5, 2024