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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

The Associate Director of Quality Control Laboratories is responsible for leading the successful operation of the laboratory organization. Provides strategic leadership, directs, coaches and plans resources and budgets to ensure laboratories run in accordance with cGMP guidelines and relevant regulatory requirements, organization’s global strategy and the site’s goals and objectives. This position leads the following teams, as applicable: raw material/incoming laboratory, analytical, microbiology and stability laboratories which support testing of incoming materials, API/Drug Substance and finished products. The Quality Control laboratories are responsible for environmental monitoring and clean utilities routine testing to ensure facilities and utilities remain in their qualified state. This position serves the laboratory SME during internal and external regulatory audits.

Responsibilities

• Directs management of lab operations which includes, as applicable: raw materials and product testing, new product introduction, long term and annual stability commitments, method transfers, laboratory equipment qualification, environmental monitoring and clean utilities testing, amongst others.

• Sets strategy, develops and manages operating budget of a large and highly technical organization. Drive a quality culture and healthy employee engagement level within the teams.

• Provides technical leadership in a multidisciplinary laboratory environment to ensure activities support business needs while maintaining full compliance with internal quality system requirements and external regulations.

• Ensures laboratory processes, procedures and methods are in conformance with corporate procedures, pharmacopeia and applicable regulatory requirements.

• Designs and leads advanced independent scientific initiatives per business needs.

• Actively partners with Regulatory Affairs and Global functions during regulatory submissions for new product introductions or post approval changes. Ensures testing completion and data reports are provided according to regulatory submissions timelines.

• Establishes relationships with external laboratories that provide services to the QC laboratories. Monitors performance of external service providers and ensures their performance is in compliance with AbbVie’s policies and procedures.

• Leads shared services functions that support the laboratory organization which includes procurement of materials, supplies, instruments, reagents and equipment.

• Responsible for executing the annual stability program commitments of the site and other sites within the region.

• Manages the Capital Plan and LRP for the QC Labs.

Qualifications

Qualifications:

• Bachelor’s degree in science and 10 + years of relevant experience in quality/regulatory in pharma, biologics, or equivalent regulated industry or Master’s degree and 8+ years of relevant experience. Preferred PhD in science and 6+ years of relevant experience.

• Previous experience as a people leader is required.

• Demonstrated people management skills including leadership, strategic planning, delegation, and follow up along with recruiting, developing, and retaining key talent.

• Demonstrated knowledge in Quality Systems, Quality Control Operations practices, and procedures.

• Knowledge of risk analysis tools and statistical methodology. Solid understanding of quality laboratory operations and the science behind it.

• Ability to make operation and business decisions with minimum oversight.

Significant Work Activities:

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

• Continuous standing 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

• Work in a clean room environment

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. ​

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, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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