Third Party and Supplier Quality Specialist

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.

Job Summary
This position is responsible to provide Quality oversight of GMP suppliers and site service providers, including contracted operations within the product portfolio of the Site’s Manufacturing processes.

Job Details
This position is responsible for the following:

 

• Supplier Quality Oversight for GMP suppliers and site service providers.
• Responsible for maintaining the Approved Supplier List (ASL) in Global Trackwise, including associated supporting documentation, where applicable.
• Developing and maintaining Suppliers and Site Service Providers Audit schedule.
• Performing Supplier Audits (e.g. questionnaires, desk-top and/or on-site).
• Responsible for generating, and maintaining Quality Agreements, as needed.
• Interacting with both, the Global Quality Agreement and Audit Teams providing information related to suppliers applicable to multiple sites within the Organization. These requests may include but are not limited to Supplier Quality History, Audit Requests, Risk Assessments, Supplier Quality Risk alerts, Review of Global Quality Agreements, etc.
• Assisting the local and global Change Control Programs with Supplier Quality Evaluations and Customer Notifications, where applicable.
• Approval of Purchase Orders (PO’s) from a Quality perspective.
• Executes investigations in conjunction with Local and Global Procurement, as it relates to supplier complaints, supplier quality events, etc.
• Serving as the Quality liaison for Supplier Quality requests with all Site vested parties including QA/QC laboratories, BT, Manufacturing and Engineering.
• Quality liaison with customers for Contract Manufacturing Operation (CMO) services provided by the Site.
• Participation in preparatory activities for Site regulatory, customer and corporate inspections.
•  Responsible for maintaining key performance indicator metrics for trending and monitoring of the Supplier Quality Program.
• Review and approval of site documents and records including, but not limited to SOPs, Trackwise records, etc. from a Quality perspective.

Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.

Regulated Responsibilities (including cGMP and EHS)

Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

 

Qualifications

Education and Experience:
Minimum requirements for this position are:

Education

• Minimum of a B.S. in Engineering, Statistics, or Sciences degree from an accredited institution. Experience in Quality Assurance functions will be considered in lieu of a science degree.

Certification 

• CQE or other ASQ certification a plus.

Experience

• Technical Three (3) to five (5) years minimum experience in pharmaceutical manufacturing industry with a minimum of three (3) years working in relevant areas such Quality Assurance, Supplier Quality, Procurement or Pharmaceutical production experience.

Experience

• BT Systems Strong computer knowledge is required including Microsoft Office and the ability to learn relevant internal computer systems. Trackwise and SAP working experience highly preferred. Familiarity of Excel and Statistical programs. CSV experience a plus.

 

Essential Knowledge, Skills & Abilities:

• Excellent verbal and written communication skills.
• Detail-oriented and self-motivated.
• Must have auditing skills through training and/or experience.
• Possesses skills in exercising a high degree of initiative, judgment, discretion and decision making to integrate organizational priorities, meet deadlines, and achieve objectives.
• Supports or where necessary leads Quality based projects including working as part of a multidisciplinary team, as required.
• Provides technical assistance to stakeholders for resolution of complex problems.
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
• Quality Systems experience in a regulated environment (FDA/GMP, CFRs, ISO 13485, non-US Agency experience for example HPRA, PMDA, etc.).
• Experience in OPEX and Six Sigma Black Belt methodologies, including problem solving tools preferred.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.