Associate Director, Quality Assurance
Company: AbbVie, Inc.
Posted on: February 25, 2021
Job Description About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
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, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com . Follow @abbvie on Twitter ,
Facebook , Instagram , YouTube and LinkedIn .
The Associate Director, Quality--is responsible for providing
quality assurance support for some or all of the following
manufacturing processes: pharmaceutical products, medical devices,
combination products and biologics. This role will develop and
support the strategic direction to ensure business objectives are
met by managing large and/or complex initiatives. This position
will also translate strategy into tactical objectives to deliver
strategic plans and regulatory updates. Specific areas of support
may include the Resource Planning and Scheduling for all QA and QC
activities at a large, multi-use Biologic Manufacturing
Facility.--This position will ensure that all product, process or
system related quality activities from supplier and TPM management
to raw material inspection through shipment of final product are in
compliance with Corporate and governmental regulations.
- Ensure proper development, integration and support of quality
regulations: drug, biologics, device and/or combination
- Responsible for initiation, selection, coordination and
management of quality systems projects. Lead project teams and/or
direct staff in planning, preparation, review and approval of
- Responsible for implementing and maintaining the effectiveness
of the quality system for drug, biologics, device and/or
combination products including compliance with Corporate policies,
processes and procedures.
- Design effective quality systems, procedures and/or processes
within cross functional teams to ensure compliance as well as
efficiency throughout our quality system. May be required to
prepare and present data during regulatory audits (FDA, EMA,
Anvisa, etc) and internal audits.
- Manage and oversee the interrelated function activities
including design control with R&D, Manufacturing
- Science and Technology (MS&T), Supply Chain, Program
Management, Commercial, Medical, Pharmacovigilance, and Regulatory
- Lead quality system elements, training, continuous improvement,
and tactical support across functions, plants, and affiliates.
- Oversee new product introduction for pharmaceutical products,
biological products, medical devices, or combination products.
Support design changes to existing medical devices and combination
- Interact with internal and external partners for development of
best practices in our quality systems and procedures.
- Review assessments to determine compliance to processes and
regulations to identify potential gaps and mitigate and implement
improvements within our quality system.
- Oversee the implementation and management of training and
education programs for various aspects of quality assurance.
- Bachelor's Degree in Chemistry, Pharmacy, Biology,
Microbiology, Engineering or other technical/scientific area.
- 10+ years' experience in quality assurance, quality oversight
or relevant experience.
- Proven managerial leadership of technical professionals and/or
in leading cross-functional teams.
- Technical knowledge in as many of the following areas as
possible: Quality, Regulatory, Process Sciences,
- Manufacturing Operations.
- Knowledge and familiarity with product, process, equipment, and
facilities of pharmaceutical, biological or device related
- Knowledge of QA systems and GMP compliance requirements
including regulations and standards affecting device, biologics,
and pharmaceutical products.
- Experience working and/or managing in both team setting and
independently. Works well with minimal manager guidance while able
to manage own time and/or teams effectively.
- Strong oral (with all levels of management) and written
communication skills needed.
- Excellent interpersonal skills a plus.
- Can create strategic plans integrated into the overall quality
system to deliver large and complex programs or projects.
Significant Work Activities
Yes, 20 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer we do not discriminate on the
basis 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, protected veteran status, or
any other legally protected characteristic.
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Keywords: AbbVie, Inc., Worcester , Associate Director, Quality Assurance, Executive , Worcester, Massachusetts
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