Senior Manager, Product Development Quality Assurance (CMC Product Lead)

About the role

The Senior Manager, Clinical Product Supply supports AbbVie’s pipeline by ensuring high-quality clinical supplies that meet global regulatory requirements and standards are delivered to patients. They provide direction and quality oversight of the supply chain, including manufacturing, testing, and release processes from drug substance to drug product to finished product.

Responsibilities

• Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management.
• QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines.
• 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 staff.

Requirements

• Bachelor's degree (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
• Master's degree is preferred but is not required based on commensurate experience.
• 8+ years 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.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) 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.

Qualifications

• Must be legally authorized to work in the United States without the need for employer sponsorship, now or in the future.

Skills

• Strong knowledge of pharmaceutical manufacturing processes (chemical and biological).
• Understanding of global requirements for GMP (D, EU, US).
• Experience in project management and ability to manage multiple priorities.
• Leadership, communication, and organizational skills.
• Ability to provide and defend the quality position, and effectively problem solve complex technical and quality issues.

Benefits

AbbVie offers a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan to eligible employees.

Pay

$124,500 - $236,500 USD

Schedule

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.