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Sr. Manager, QA Training

3 months ago

Worcester, United States AbbVie Full time
Job DescriptionJob DescriptionCompany 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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Are you ready to take on a leadership role and make a significant impact on the Quality Function within Operations? Look no further We are currently seeking a dynamic and experienced Senior Manager to lead our Quality team.

As the Senior Manager of Quality Traning, you will be responsible for the effective implementation of AbbVie Quality Systems. This includes overseeing Training and Document Control, ensuring compliance, and maintaining high quality levels on all products. You will have the opportunity to manage a budget and lead a team of talented quality professionals who are dedicated to achieving excellence.

We are looking for someone who is passionate about quality, possesses strong leadership skills, and is capable of driving strategic initiatives. If you thrive in a fast-paced environment and are committed to delivering high efficiency while maintaining top-notch quality, this is the perfect role for you. Apply Now 

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.
  • 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.
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
  • 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 verbal and written

Key Stakeholders 

• Development, Manufacturing, Quality and Regulatory



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 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.