Director, Quality Audit Management

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:

As the head of a new global GxP Quality audit management function reporting directly to the Head of Quality, this individual will be responsible for leading and managing Ironwood's global self-inspection and external GxP audit programs. This Quality professional is a resourceful self-starter and team player, who acts with a sense of urgency and operates independently with minimal oversight. This member of the Quality team is a subject matter expert in managing internal and external GxP audits/self-Inspections and is familiar with US, UK, EU and other international GxP regulations/requirements. This individual is expected to collaborate with internal and external stakeholders and peers in a professional and respectful manner.

Responsibilities:

  • Lead the Quality Audit Management group.
  • Manage the internal self-inspection and external GxP audit programs by performing or overseeing the following activities:
    • Establish a contract auditor network and process contracts.
    • Maintain annual audit schedules.
    • Coordinate audit logistics.
    • Ensure the proper documentation is produced in a timely manner and in accordance with Ironwood's internal procedures (e.g., Agenda, Report, Responses, CAPA, etc.)
    • Providing feedback to stakeholder groups
    • Measure and evaluate audit performance (business and compliance) using standard metrics, and report periodically to Quality and our business partners.
    • Manage and/or conduct periodic review audits of GxP computer systems.
    • Documenting all audit-related activities using the Ironwood eQMS
  • Attend meetings with stakeholders.
  • Lead and facilitate all Inspection Readiness (IR) activities.
  • Continuous process improvement through procedural updates, developing and maintaining a set of audit tools and databases, internal and external networking, corporate promotion, etc.
  • Build and maintain a high performing team.
  • Promote the Quality culture via Quality Awareness Campaign initiatives.
  • Establish the annual budget for the AIM group and maintain costs within the budget.
  • Recruit and hire additional resources (i.e., contract and FTE)
  • Performing and processing investigations, deviations, and CAPA using the Ironwood eQMS

Requirements:

  • Bachelor's degree in a scientific discipline (or equivalent)
  • 15 years' experience in the pharmaceutical industry; the last 10 years in a lead auditor/ senior Quality role
  • Knowledge of FDA, MHRA, and EMA GxP regulations, guidelines, and industry standards as a minimum
  • Proficient in the use of MS Office applications and experience operating within an electronic QMS.
  • Strong organizational, prioritization, planning, project management and communication skills
  • Proficient in performing risk and impact assessments, including implementation of mitigation actions and risk monitoring.
  • Ability to perform various tasks in a disciplined, consistent manner under minimal supervision.
  • Effectively presents information in a 1-1 or group setting.
  • Comfortable working in a fast paced, dynamic environment.
  • Able to work remotely in an efficient and effective manner.
  • Minimum 10% travel time

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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