Associate Director, Quality - Lincoln, United States - Allergan

Allergan Lincoln, United States

1 week ago

Description

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 . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description
The Associate Director, Quality provides leadership and direction to the Quality Function they are responsible for within Operations.

This Associate Director, Quality is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for.

This could include:

Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives.

The Sr.

Manager of Quality would be expected to manage a budget and leads a team of quality professionals who are responsible for compliance and quality oversight for the plant and/or strategic initiatives.

Expectations that the professional will maintain high quality levels on all products while achieving high efficiency.
Responsibilities
Responsible for various aspects of quality assurance and quality control related to products produced at the plant.

This will be at a large plant with high volume, high level of product complexity including multiple products at the site and may have the complexity of multiple types of productions (API, Fin Goods, Biologics, Packaging, Device, etc.).

Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance program for the site.

Ensures that product within the plant is consistently manufactured in conformance with corporate Quality requirements and all applicable regulatory requirements.

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

Provides regulatory and technical guidance to all departments in the plant and can be the SME for all AbbVie plants.

Communicates with executive level for Quality Management Review, Quality Initiatives, etc.
Responsible for the development and administration of the annual operating budget for the Quality Unit they are responsible for.

Incumbent is responsible for quality decisions related to all aspects of the plant operation including facility design, laboratory controls and product specifications and to ensure that the area of their responsibility meets all cGMP, FDA, EU, DEA and other regulatory requirements.

Manages a team in the Quality Function to include hiring, setting performance expectations and performance assessment.

Qualifications
Minimum Bachelor's Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering; Master's Degree or PhD preferred.
Certified Quality Engineer or formal training in quality engineering or statistics is preferred
15+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry

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
10+ years of supervisory/technical leadership experience

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelievesingood faith it will pay for this role at the time of this posting based on the job grade for thisposition.

Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range.

This range may be modified in thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays,sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible to participate in our short-term incentiveprograms.

This job is eligible to participate in our long-term incentiveprograms

Note:
No amount of payis considered to bewages or compensation until such amount is earned, vested,anddeterminable.

The amount and availability of any bonus, commission, incentive, benefits, or any other formofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company's sole and absolute discretion, consistentwithapplicable law.

AbbVie 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.

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