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Senior Vice President of Quality Assurance
2 months ago
Company Overview:
Ironwood Pharmaceuticals is a prominent player in the gastrointestinal (GI) healthcare sector, dedicated to enhancing the treatment landscape for GI disorders and setting new benchmarks in patient care. Our focus lies in the discovery, development, and commercialization of groundbreaking therapies for patients suffering from severe, rare conditions that often go undiagnosed and lack adequate treatment options.
Lead Product:
Our flagship candidate, Apraglutide, represents a state-of-the-art synthetic peptide analog of glucagon-like peptide-2 (GLP-2) and is currently in Phase 3 trials aimed at treating short bowel syndrome (SBS), a condition resulting from the loss of functional small intestine. This is a pivotal moment for our organization as we advance through Phase 3 and prepare for an initial market introduction, necessitating the expansion of our global commercial footprint.
Position Summary:
Reporting directly to the Chief Financial Officer, the Senior Vice President of Quality Assurance will spearhead the strategic direction and management of the Quality division. This role is crucial in fostering a culture of excellence and compliance with all regulatory mandates while prioritizing quality optimization and risk mitigation. The ideal candidate will be a seasoned and innovative leader in Quality, tasked with building, guiding, and motivating a high-performing Quality team dedicated to establishing a premier Quality organization that supports the successful commercialization of our innovative clinical therapies and marketed products.
Key Responsibilities:
- Formulate and implement global quality strategies that align with business goals and regulatory requirements.
- Ensure comprehensive understanding and adherence to quality policies and objectives across all organizational levels.
- Maintain an effective suite of Standard Operating Procedures to support essential internal functions and vendor partnerships.
- Oversee a robust, risk-based audit program across our vendor network, managing supplier quality and third-party oversight initiatives.
- Negotiate and establish beneficial quality agreements with Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), partners, and suppliers.
- Develop key quality metrics and process indicators to proactively identify and resolve quality system or product issues.
- Lead Quality Management Reviews for all Good Practice (GxP) activities, ensuring uninterrupted business operations free from quality or compliance disruptions.
- Champion continuous improvement initiatives in total quality management through a well-trained workforce and streamlined processes.
- Collaborate closely with cross-functional teams, including R&D, Technical Operations, Regulatory Affairs, and Pharmacovigilance, to ensure the integration of quality standards throughout the product lifecycle.
- Serve as the primary liaison for communications with regulatory authorities, ensuring effective representation in all interactions.
- Build and lead a high-performing Quality organization through effective performance management, team development, coaching, and mentoring.
Qualifications:
- Advanced degree in a relevant scientific or operational discipline.
- At least 15 years of quality experience in the biotech or pharmaceutical industry, with a minimum of 5-7 years in a leadership role.
- Experience with late-stage and commercial products.
- Familiarity with quality systems for injectables and drug-device combination products; experience with peptide products is advantageous.
- In-depth knowledge of quality systems, standards, and compliance.
- Proven experience in managing regulatory inspections and interacting with government officials.
- Multidisciplinary expertise in Clinical and non-Clinical quality requirements.
- Strong understanding of FDA and EMEA regulations and guidelines in GLP, GCP, and GXP environments.
- Successful track record with regulatory inspections, audits, and due diligence processes.
- Experience contributing to successful New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions.
- Proficient in managing vendor relationships.
- Established leader with a proven ability to develop, coach, and inspire teams within Quality organizations.
- Exceptional communication skills, both oral and written, suitable for engaging with all levels of the organization and external partners.
- Demonstrated success in building and leading high-performing quality teams.
- Strong interpersonal skills with the ability to influence and resolve challenges diplomatically.
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.
