Senior Quality Engineer, Risk Management in Irvine

AbbVie is a global biopharmaceutical company. The Senior Quality Engineer, Risk Management has various objectives/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day-to-day Quality Assurance activities related to the TPM plants including but not limited to:

• Approval of manufacturing direction to the production floor
• Review and approval of manufacturing, laboratory, and raw material investigations
• Assessment of product impact analysis and corrective and preventive action for events
• Review and approval of changes as applicable

The Senior PQA Analyst also evaluates supplier change notifications, monitors process track and trending, and performs annual Product Quality Reviews. This person acts as a liaison between AbbVie regulatory areas and TPM plants for regulatory submission.

Responsibilities:

• Maintains an effective liaison and cooperative relationship with other AbbVie Areas including but not limited to Quality, Regulatory, Technical, and Supply Chain, along with the TPM sites.
• Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by AbbVie QA Operations.
• Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
• Reviews and approves manufacturing directions to the production floor.
• Provides support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.
• Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.
• Performs annual Product Quality Review according to AbbVie global procedure to comply with regulatory requirements.
• Participates in Trend Review Board to monitor process track and trending.
• Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impact all sites.
• Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation.

Qualifications:

• Bachelor’s degree preferably in Engineering or Science
• Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
• Knowledge of GMP regulations and standards affecting pharmaceutical products
• Comprehensive knowledge and application of business and quality concepts
• Strong analytical skills and attention to detail
• Change plan, Exception Reports, SAP and LRMS experience is highly preferred
• Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
• Strong interpersonal relations/communications skills. Ability to effectively communicate across all levels of the organization

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 short-term incentive programs.

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.