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Responsible for oversight of all quality aspects related to manufacture of commercial & clinical products at third party service providers (CMOs, CDMOs, test labs). In partnership with Regulatory Affairs, Technical Operations Staff, and Alliance Management the QA Manager will ensure that products are manufactured in accordance with cGMPS, regulatory guidelines, Assertio requirements and internal procedures. Will assist in due diligence for business development activities and integration deliverables.
Responsible for assisting with pharmaceutical licensing, subsidiary maintenance and other corporate secretarial matters, compliance oversight and reporting, monitoring of related party transactions, Section 16, proxy and other SEC reporting and disclosure, corporate governance, contract review and approval, and assisting the legal department on other matters that may arise. In addition, the individual in this role will work closely with multiple attorneys, other members of the Legal Department and business clients providing legal support for a wide array of corporate transactions.