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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 primary focus is on the discovery, development, and commercialization of groundbreaking therapies for patients suffering from severe, rare conditions that lack adequate treatment options.
Our lead candidate, Apraglutide, represents a state-of-the-art, synthetic peptide analog of glucagon-like peptide-2 (GLP-2), currently in Phase 3 trials aimed at addressing short bowel syndrome (SBS), a malabsorption disorder resulting from the loss of functional small intestine. This is a pivotal moment for our organization as we advance towards a global commercial launch.
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 within the organization, with a strong emphasis on optimizing quality standards and mitigating risks. The ideal candidate will be a seasoned and visionary leader in Quality, responsible for cultivating, guiding, and motivating a high-performing Quality team that embodies a best-in-class quality ethos to support the successful commercialization of our innovative clinical therapies and marketed products.
Key Responsibilities:
- Formulate and implement comprehensive global quality strategies that align with corporate objectives and regulatory requirements.
- Ensure that quality policies and objectives are effectively communicated, understood, and upheld across all organizational levels.
- Establish and maintain a robust suite of Standard Operating Procedures to support critical internal operations and external partnerships.
- Oversee a comprehensive audit program to identify and address potential quality issues within our vendor network, ensuring adherence to quality standards.
- Negotiate and develop beneficial quality agreements with Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and other partners.
- Generate key quality metrics and process indicators to proactively manage and resolve quality system or product-related challenges.
- Lead Quality Management Reviews for all Good Practice (GxP) activities, ensuring uninterrupted business operations.
- Champion continuous improvement initiatives across all facets of total quality management through effective training and knowledge-sharing programs.
- Collaborate 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 regulatory interactions.
- Develop and nurture a high-performing Quality organization through effective performance management, coaching, and mentorship.
Qualifications:
- Advanced degree in a relevant scientific or operational discipline.
- A minimum of 15 years of quality experience within the biotech or pharmaceutical industry, including 5-7 years in a leadership role.
- Experience with late-stage and commercial product quality systems.
- 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 protocols.
- Proven experience in managing regulatory inspections and interactions with government officials.
- Multidisciplinary expertise in both 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 submissions and audits.
- Experience in vendor management and oversight.
- Established leadership capabilities within the pharmaceutical sector, with a focus on developing and inspiring Quality teams.
- Exceptional communication skills, both written and verbal, suitable for engaging with all levels of the organization and external partners.
- Proven ability to build and lead a high-performing quality team.
- Strong interpersonal skills, with the ability to influence and resolve challenges effectively.
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.
