Global Packaging Assurance Manager

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.

Major Responsibilities:

• Establish and maintain system to ensure high quality supply of packaging components and materials with appropriate KPIs and oversight.
• Conduct quarterly management review meetings on packaging supplier performance including CAPA closure, repeat incidents (incoming inspection or in process), and audit compliance status.
• Train / Mentor members of Global Packaging staff to embed quality and continuous improvement throughout the packaging development process from concept to commercialization and ongoing support.
• 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 supply continuity.
• 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.

Qualifications

• 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 manufacturing plant.
• 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 materials.
• Must possess good written and verbal communication skills.
• 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 collaborators.
• Works well with other engineers in a collaborative, fast-paced goal-driven environment.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.