Senior Manager, Quality Engineering

The Senior Manager Quality Engineering provides leadership direction and technical oversight for the Quality Engineering team within Operations. This role leads quality engineers who support manufacturing processes and provide quality engineering expertise for product process equipment utility and facility-related activities. The position ensures effective implementation of AbbVie Quality Systems and supports validation qualification and risk-based compliance decisions across base business and development or market expansion initiatives. The Senior Manager also manages functional resources and budget while maintaining strong quality compliance and operational performance.

Responsibilities:

• Leads and develops a team of quality engineers supporting manufacturing process quality oversight validation qualification and compliance activities.
• Provides functional leadership for quality engineering activities across manufacturing processes equipment utilities facilities and associated systems.
• Provides technical direction for quality engineering matters related to base business operations development tech transfer and market expansion projects.
• Ensures validation and qualification strategies protocols reports and lifecycle activities are executed in accordance with AbbVie Quality Systems cGMP requirements and applicable regulations.
• Reviews quality and compliance gaps related to manufacturing processes equipment utilities systems and change controls and drives appropriate risk-based actions.
• Partners with Manufacturing Validation Engineering Regulatory Quality Systems and Development to support compliant implementation of new and existing processes.
• Guides risk management activities including assessments mitigation planning and application of quality risk management principles.
• Oversees or supports qualification and validation activities for equipment processes cleaning utilities computerized systems and methods as applicable.
• Ensures quality engineering issues impacting product quality process robustness and regulatory compliance are identified escalated and resolved.
• Communicates quality engineering status key risks trends and recommendations to management and executive stakeholders and manages functional resources and budget to support efficient execution.

Qualifications :

• Minimum Bachelors Degree required preferably in Physical or Life Sciences Pharmacy or Engineering
• Certified Quality Engineer or formal training in quality engineering or statistics is preferred
• 8 years of combined experience in Manufacturing QA QC R&D in pharmaceutical biologics device or chemical industry
• 4 years of supervisory/technical leadership experience
• Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products including raw materials manufactured at the plant.
• Must be familiar with use of statistical quality systems electronic document management and laboratory information management.
• Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
• Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing materials management engineering product development Quality Systems Product QA Quality Control Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.
• Strong communication Skills both oral and written

Preferred: 

• Bachelors Masters or PhD in a Life Science or Engineering is Highly Desired.
• Demonstrated strategic vision and leadership in building and sustaining a high-performing team responsible for managing base business priorities site-related projects compliance remediation activities and global project deliverables is Highly Desired.
• Strong cross-functional collaboration and negotiation skills with the ability to influence stakeholders align priorities and drive effective outcomes across complex and diverse functional teams is Highly Desired.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• 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 thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time