Vice President, Quality

3 months ago

Boston, United States Ironwood Pharmaceuticals Full time

Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options.

The lead product candidate, Apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a global commercial presence.

Description:

Reporting to the Chief Financial Officer, the Vice President, Quality is responsible for providing the strategic leadership and management of the company's Quality organization. This individual will ensure Ironwood maintains a culture of quality and compliance with all regulatory requirements and will focus on optimizing quality and reducing risk. The successful candidate will be a highly experienced and innovative executive Quality leader who will be responsible for expanding, leading, and inspiring a Quality team that promotes a best in-class Quality organization to enable the robust commercialization of our advancing clinical therapies and marketed products. This leader will be accountable for shaping the Quality organization. The VP, Quality will have end-to-end Quality responsibilities inclusive of leading GLP, GCP, and GMP functions.

Responsibilities:

  • Designs and executes global quality strategies aligned with business objectives and regulatory standards.
  • Ensures that the quality policies and objectives are understood, implemented, and maintained at all levels of the organization.
  • Assures that the appropriate suite of Standard Operating Procedures is in place and optimally maintained to support critical internal activities as well as with our vendor relationships with external CRO, CDMO or CMOs.
  • Ensures a robust and risk-based audit program is successfully realized throughout our vendor network. Oversees the supplier quality and third-party oversight programs, including audits to identify potential quality issues, deviations or non-conformities, and implement appropriate corrective and preventative actions.
  • Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our CMO's, CRO's, partners and suppliers.
  • Develops key quality system metrics and process indicators to proactively identify and address quality systems or product issues.
  • Leads Quality Management Review for all GxP and assures that there are no significant interruptions to the business due to quality or compliance issues.
  • Acts as a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes and appropriately structured quality operations. Fosters a quality and continuous improvement culture by organizing training programs, workshops and knowledge sharing initiatives.
  • Collaborates closely with cross functional teams, including R&D, Technical Operations (Pharmaceutical Development, Manufacturing, CMC, Supply Chain), Regulatory affairs, Pharmacovigilance, to ensure seamless integration of quality standards throughout the product lifecycle.
  • Acts as primary interface for communications with Regulatory authorities ensuring the company is appropriately represented in communications with the health authorities.
  • Develops and leads a high performing Quality organization through performance management, team development, coaching and mentoring.

Requirements:

  • Advanced degree in a scientific or operational discipline relevant to life sciences
  • Minimum of 15+ years quality experience in a biotech/pharma environment with at least 5-7 years as functional head of quality
  • Experience with products in late-stage and commercial stage companies
  • Experience with quality systems for injectables and drug-device combination products. Experience with peptide products a plus.
  • Deep working knowledge of quality systems, standards and compliance.
  • Experience hosting and facilitating regulatory inspections and skilled in interacting with government officials.
  • Multidiscipline expertise and experience with Clinical and non-Clinical requirements and responsibilities
  • Excellent working knowledge, understanding and experience with the practical implementation of FDA and EMEA regulations and guidelines in GLP, GCP and GXP environments
  • Successful experience with Regulatory inspections, audits and/or due diligence
  • Experience contributing to successful NDA and MAA submissions
  • Experience managing, overseeing and working with vendors
  • Established leader in the pharmaceutical industry with clear and proven capability developing, coaching, communicating, leading, managing and inspiring within and beyond Quality organizations and efforts
  • Excellent oral and written communication skills to all employment levels, Board, and external partners, suppliers and industry organizations
  • Proven experience in building and leading a highly performing quality team
  • Strong interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact and diplomacy.

Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Ironwood currently anticipates that the initial base salary for this position could range from between $325,000 to $375,000. 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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