Quality Validation Manager is responsible for maintaining and ensuring plant compliance to corporate policies and procedures for Validation. The manager will lead a team of QA Validation professionals responsible for quality oversight of validation and qualification procedures / executed packages for facilities, utilities, equipment, lab instruments, computerized systems, test methods, cleaning validation, and shipping validation.
Responsible for plant validation activities including equipment and process risk documentation (i.e., FMEA, CVRA), commissioning, qualification, and validation.
QA oversight in the development, review and execution of protocols, reports, and risk assessments.
Ensure plant compliance to the Validation program with AbbVie Quality Systems for validation to comply with 21 CFR Part 11, 58, 210 and 211, FDA regulations and guidelines.
Gather and evaluate data for trending and monitoring of the validation process, and as a QA validation SME, lead validation support for regulatory, internal and client audits.
Lead the QA Validation Review department, coordinate execution of validation activities and deliver right first time and on time execution.
Proactively identify, implement, and drive continuous improvement by monitoring metrics and implementing lessons learned.
Responsible for the planning, organization, administration and general supervision of direct staff and contract personnel.
Ensure employee resource allotment and workload requirements are balanced to meet the needs of the business daily as well as forecasting future work capacity based on the strategic objectives of the plant.
What You Will Have:
B.A. or B.S. degree, preferably in pharmaceutical, biotech, or engineering related field.
Minimum 10+ year’s experience with Qualification/Validation of facilities, utilities, equipment, Whatprocesses.
Minimum 2+ years supervisory/management experience.
Strong working knowledge of GMP and industry regulatory (FDA) requirements.
Hands-on experience in at least one of the following areas: Cleaning Validation, Process Validation, Quality System Assessments and Implementation, Auditing and Gap/GMP Assessments, Manufacturing Operations in Pharma/Biopharma, Process Engineering or Equipment, Facility and Utility Qualification.
Ability to analyze, investigate and provide strategies to technical and regulatory issues.
Strong creative problem solving and analytical skills.
WhatYou Will Receive:
Comprehensive Healthcare: Medical, Vision, Dental, FSA, HSA
Financial Well-being, Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
AbbVie Vitality: Health & Wellness programs including Employee Assistance Program (EAP), Health Advocate, Global Well-Being Programs
Generous Paid Time Off include, Company Holidays, Vacation, Parental and Caregiver Leave
Community Outreach Programs and company match of charitable contributions
Perks include AbbVie Product Shop, Employee Loyalty Program, Tuition Assistance, Adoption and Surrogacy Assistance, Mothers at Work and Milk Stork to list a few
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced