Job Details

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of QC leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QC Head.

Responsibilities:

• Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions or incident.

• Direct RM & Incoming laboratory operations and programs such as RM & Incoming methods for materials, excipients, API, commodities. Testing of raw materials, commodities, USP water and cleaning samples.

• Responsible for elevating to the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Reviews and approves laboratory instrumentation, utilities, and facilities qualification and labs system life cycle documentation.

• Responsible for all raw and incoming materials and commodities (including ERP approval) in the Quality Control (QC) laboratory including direct reports and budgetary responsibilities.

• Serves as the standalone laboratory systems and site Maximo administrator. Comply with AbbVie policies, ABL plant procedures, Food and Drug Administration (FDA), EMA, and other applicable regulatory agencies cGMP regulations and requirements.

• Responsible for end results of the Incoming Quality Assurance area. Assures that all incoming materials received at ABL are inspected, sampled, tested, and disposition according to established policies and procedures. Provides strategic direction for area of operation and ensures tactical objectives are met.

• Responsible for front- and back-room support activities for the RM and Incoming Lab during internal audits, Periodic Validation Review, Annual Product Reviews, and process data reviews and inspections.

• Represents the decision-making authority on change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests. Leads the implementation of Quality-related projects, including metrics.

• Manages a team of quality professionals. Directly responsible for the effective organization, administration, training, and supervision of their functional area.

• Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs; qualification and validation protocol writing, review, and approval.

Significant Work Activities:

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

• Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr. day) is required

• Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

Qualifications

• Bachelor’s degree Science (Chemistry or Biology) with 10 years of pharmaceutical (parenteral biologics preferred) Quality experience (preferably in QC) or an equivalent combination of education and experience.

• Experience managing raw and incoming materials.

• Knowledge in raw materials /Incoming Materials programs under ANSI guidelines is required.

• Supplier Quality Programs knowledge and experience.

• The selected candidate must be fully bilingual written and verbal, both in English and Spanish.

• Experience with SmartQC, LIMS (Sample Manager), Empower is desired.

• Previous experience leading teams.

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 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. ?

• 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, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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

https://www.abbvie.com/join-us/reasonable-accommodations.html