Manager, Product Development Quality Assurance

About the Role

This role is primarily responsible for supporting AbbVie's pipeline by supporting batch disposition activities and ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. This is achieved by effectively partnering with the business, ensuring risks are mitigated appropriately, and supporting efficient review of clinical supply batches to maintain uninterrupted access to clinical supplies. The successful candidate will manage multiple tasks, adjust priorities based on supply needs, positively interact with multiple functional areas, mentor and coach peers, and resolve batch record documentation issues independently to maintain schedules and material availability.

Responsibilities

• Review and approve batch records and release batches or analytical records.
• Write, review, and approve processes, procedures, and related documents.
• Lead or assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Review draft and final regulations for impact to R&D business and incorporate procedural changes as necessary.
• Provide routine area-specific management support (act as backup to manager for routine management activities).
• Support daily product release activities as applicable to the organization.
• Drive consistency and continual process improvements within PDQA through assessment and compliance of regulations and industry practice.
• Write, review, and approve exception reports, including high-impact and complex ERs affecting multifunctional areas.
• Actively lead or participate on assigned project teams to support product development.
• Monitor the effectiveness of processes and quality of project work with management, and propose and execute quality or process improvements.

Qualifications

• Bachelor’s degree, typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
• Master’s degree is preferred but not required based on commensurate experience.
• 6+ years of industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development, or other healthcare-related fields; less experience considered with an advanced degree.
• Supervisory or project management experience is a plus (not required).
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide/global requirements for GMP (D, EU, US) is preferred.
• Ability to provide and defend the quality position and effectively problem-solve complex technical and quality issues.

Pay

The compensation range for this role is based on the job grade at the time of posting and may vary depending on geographic location. Individual compensation paid within this range will depend on several factors, and the final amount is at the Company’s discretion, consistent with applicable law.

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan for eligible employees.
• Eligibility to participate in long-term incentive programs.