Director, Quality Systems

2 weeks ago

Boston, United States Ironwood Pharmaceuticals Full time

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 Quality, this individual will be tasked with setting-up, maintaining and further developing the internal GxP quality management system (QMS), learning management system (LMS) and associated quality policies, procedures, and standards to fully support Ironwood's drug development and commercialization activities. In addition, this individual will be responsible for directly supporting the organization, coordination, and management of Regulatory Agency inspections and audits by external parties at Ironwood Pharmaceuticals, Inc. and to present all QMS related topics to inspectors/auditors.

As the Head of the Quality Systems and Compliance group, this individual will provide proactive leadership and direction, enable growth and development of Quality staff, and promote cross-functional collaboration with Quality business partners, both internal and external.

Responsibilities:

  • Promote the Quality culture and philosophy companywide.
  • Support the Head of Quality in developing and implementing the overall Quality strategy.
  • Manage one or more full-time staff responsible for maintaining GxP Quality controlled documents and coordinating GxP compliance training.
  • Maintain and further develop the global Quality Management System (QMS), the GxP Learning Management System (LMS) and other GxP related systems and provide periodic updates to Quality and Executive Management.
  • Function as the business owner of the Ironwood QMS, LMS and other applicable GxP e-systems in support of the Ironwood GxP computer system validation program (i.e., assessments, validation, and change control, etc.) to ensure compliance with GxP regulations during the e-system lifecycle.
  • Develops metrics for non-compliance trends and signals.
  • Supports the preparation and conduct of GxP relevant Governance Meetings.
  • Ensure Quality Systems and Compliance personnel, along with internal business partners, maintain a state of GxP compliance and inspection readiness.
  • Generate key Quality metrics and indicators to measure, trend, manage and improve pharmaceutical quality systems and ensure trends are escalated appropriately.
  • Directly support the organization, coordination, and management of Regulatory Agency inspections and audits by external business partners
  • Develop, implement, and support continuous process improvements across multiple GxP disciplines.
  • Support the management of the field alert and recall processes and communications.
  • Ensure cross functional alignment of goals and objectives from pre-clinical to commercial phase programs and products, ensuring GXP compliance and realization of other value-added guidelines and best practices.
  • Support internal and external GxP qualification and audit activities.
  • Foster an environment conducive to innovation, productivity, and efficiency.
  • Perform other duties as assigned.

Requirements:

  • Bachelor's degree or higher in Life Sciences, Chemistry, or related field.
  • Minimum 12 years' experience in the pharmaceutical industry working in a regulated environment.
  • Minimum 10 years' experience in a Quality Systems role.
  • Minimum 5 years' experience managing personnel.
  • Working knowledge of regional GxP rules and regulations
  • Experienced in managing and actively supporting Health Authority inspections.
  • Strong knowledge of industry (e.g., FDA, EU, GxP, ICH, ISO, WHO, etc.) regulations and best practices
  • A deep understanding of the pharmaceutical industry with solid, organization, and structure is preferred.
  • In-depth knowledge of pharmaceutical quality systems, principles, and applications.
  • Ability to identify and explain complex issues and provide multiple solutions in a constructive, respectful manner.
  • Sound leadership skills.

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 $197,000 to $229,320. 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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