Global Packaging Assurance Manager
Company: AbbVie, Inc.
Posted on: February 22, 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 .
Responsible for establishing and maintaining systems to ensure high
quality and assurance of supply of packaging components and
materials for AbbVie products with appropriate KPIs and oversight.
This role requires a proven leader in Pharmaceutical and/or Medical
Device Packaging with extensive knowledge of packaging development
for primary, secondary, and tertiary packaging. Builds and
maintains relationships with key AbbVie internal stakeholders
(Packaging Sites, Quality, Purchasing and Supplier Management,
Science & Technology, R&D, Regulatory) as well as external
packaging suppliers to accomplish goals.
- Establish and maintain system to ensure high quality supply of
packaging components and materials with appropriate KPIs and
- Conduct quarterly management review meetings on packaging
supplier performance including CAPA closure, repeat incidents
(incoming inspection or in process), and audit compliance
- Train / Mentor members of Global Packaging staff to embed
quality and continuous improvement throughout the packaging
development process from concept to commercialization and ongoing
- Establish requirements for packaging specifications to ensure
appropriate balance between material purchasing, incoming
inspection testing requirements, and regulatory compliance.
- Understanding of Lab Protocols - Lab Planning - Lab Metrics -
Lab Validations; For DVT testing, provide guidance/consultation for
sampling strategy, verification strategy at protocol level
- Ensure technical oversight for audits of key packaging
suppliers in partnership with Quality and PSM.
- Perform risk assessments for key packaging component suppliers
to ensure continuity of supply (i.e. backup molds, second supply
sites, alternate materials).
- Communicate supplier change notifications to ensure appropriate
technical assessment and/or change control initiated to maintain
- Closely coordinate with Quality, PSM, and Risk Management teams
on supplier interactions and strategic partnerships.
- Understand and stay informed on new regulations that impact
packaging design requirements. Responsible for compliance with
applicable policies and procedures.
- A Bachelor's Degree in Engineering, science, or closely related
discipline is desired, or equivalent technical experience plus
demonstrated competence, with a desired 10+ years of significant
engineering and/or operational experience. A post-graduate
education/degree is desired and may contribute towards the desired
years of experience.
- Minimum 12 years of experience in the Pharmaceutical or Medical
Device packaging with a minimum of 5 years' experience in a GMP
- Deep knowledge of packaging materials and components on a
variety of pharmaceutical dosage forms including solid dosage,
sterile, and combination products.
- Knowledge of change control, risk management, relevant
regulations and industry guidance relevant to packaging
- Must possess good written and verbal communication
- Interpersonal skills needed to communicate and work with
customers and peers not under one's direction are preferred.
- Good organizational skills to set up work processes, organize
project work, run or support a meeting and effectively coordinate
and manage groups are preferred.
- Possesses a strong technical knowledge and application of
concepts, practices, and procedures. Works on problems of complex
scope where analysis of situations or data involves multiple
competing factors. Exercises judgment and advises management as to
the appropriate actions.
- Interacts well with diverse groups within engineering and
maintains strong working relationships with internal and external
- Works well with other engineers in a collaborative, fast-paced
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive
hours in an 8 hour day)
Yes, 10 % 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., Santa Rosa , Global Packaging Assurance Manager, Executive , Clearlake, California
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