Quality Assurance CMC Product Lead

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.   

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 and issue 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 ERs impacting multi-functional areas
• Provide management of clinical supply product actions and recalls
• Support in-licensing and collaboration activities
• Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers and other sites
• Interact and influence decisions of the various R&D Directors and VP as well as external customers and mentor Quality Engineers

Qualifications:

• Minimum 6+ years of industry experience in Quality Assurance, drug development or other healthcare related field; less experience considered with advanced degree.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and global requirements for GMP is required. Experience applicable to investigational products, is preferred.
• Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required.
• Strong leadership, communication, and organizational skills.
• Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.