This is a Snr. / Director of Quality opportunity with a clinical stage combination product organisation located in close to Boston, MA. They have an established quality department, and are looking to make their IND/NDA + PMA submissions in the next 12 months for their life changing oncology product. Reporting directly into the C-Suite, you'll define and lead the quality strategy for the exciting period in the product's timeline.
- Lead a Quality department for a product that has both pharmaceutical and medical device (ISO:13485, 21 CFR 820) classifications through NDA, PMA, and other regulatory filings.
- Manage and guide a team of 3 experienced quality professionals across supplier, design, systems, and drug quality.
- Report progress updates to key stakeholders at the C-Suite level routinely as the company goes through clinical stages, and upcoming new product launches.
- Initiate, review and approve investigations, risk assessments, deviations, CAPA, change records, etc. and recommend corrective actions/CAPAs related to cGMP and QMS issues
Required Qualifications & Skills
- Minimum of 10 years in Quality Assurance positions, with a combination of least 3 years in pharma/biologics, and 3 years in Medical Devices.
- 3 years' management experience undertaking performance and development reviews for direct reports
- Motivation to lead a team through clinical and regulatory to commercialization of a life saving oncology product.
- Prior experience going through clinical & regulatory submissions for new products, understanding how to navigate the FDA processes for both drugs and medical devices.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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