Manager, Product Development Quality Assurance

Job Title

This role is primarily responsible for supporting Abb Vie'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.

Responsibilities

• Review and approve batch records and release batches or analytical records.
• Write/review/approve processes/procedures and related documents.
• Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Review draft and final regulation 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.
• Responsible for driving consistency and continual process improvements within PDQA through assessment and compliance of regulations and industry practice.
• Write/review/approve exception reports, including high impact and complex ERs impacting multifunctional areas.
• Actively lead/participate on assigned project team(s) to support the product development.
• Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.

Qualifications

• Bachelors (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.
• 6+ 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.
• Supervisory/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.
• Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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US & Puerto Rico applicants seeking a reasonable accommodation,  to learn more:

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Pay Range: $109500 - 208500 USD

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.