Ensuring the timely release of GMP clinical supplies by providing direction and quality oversight of the supply chain including, manufacturing, testing and release processes from drug substance to drug product to finished product. Identifying and preventing pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.
Requirements
- A broad understanding of pharmaceutical manufacturing processes (chemical and biological) and analytical sciences.
- Strong knowledge of global GMP requirements (EU, US, etc.) and international pharmaceutical law.
- Experience applicable to investigational products is preferred.
- Must be able to provide and defend the quality position and effectively solve complex technical and quality issues.
Responsibilities
- QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines.
- Provide program oversight for the RDQA QA organization; includes timely communications on program strategies, issue and risk management.
- Lead complex global cross-functional process improvement teams.
- Provide innovative and risk-based solutions to complex technical problems.
- Support the preparation of regulatory inspections and internal audits and represent Quality in inspections and audits.
- Write/ review/ approve exception reports, including high impact and complex investigations impacting multi-functional areas.
- Provide management of clinical supply product actions and stock recovery.
Other
- Primarily responsible for ensuring the timely release of GMP clinical supplies by providing direction and quality oversight of the supply chain including, manufacturing, testing and release processes from drug substance to drug product to finished product.
- As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.
- Interact with and influence decision making at the senior leadership level as well as with external customers.
- This role can be remote within the US.
- Minimum 8+ years of industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
- Experience in project management and ability to manage multiple priorities.
- Strong leadership, communication, and organizational skills.
