Job Req # 403001
Global Manufacturing Company is looking for:
POSITION: Technical Manager (Quality and Validation)
LOCATION: Oregon, Wisconsin 53575 (right outside of Madison)
SALARY: $100-125K + Bonus
EXPERIENCE: 5+ Years Quality and Validation experience with at least 2 years in management
RELOCATION: Relocation Package
Oversee multiple teams of supervisors and hourlies
Install, maintain, and improve the site’s Quality Management System, including training, document control, and deviations.
Oversee the site’s compliance with GMPs, corporate policies, and procedures.
Creation of controlled documentation, including SOPs.
Provide key feedback on resolving compliance issues.
Review and approval of change control, deviations, CAPAs, and LIRs.
Owner of site training including scheduling, re-training, and training on revised documentation.
Support and ensure compliance of the calibration/PM system for equipment.
Review and approve documentation for the disposition of GMP components and materials
Review and approve master and executed batch records for GMP campaigns.
Lead audits of the site including regulatory and customer audits.
Maintain and execute the internal audit program.
Approves non-conformances, CAPAs, extensions and change control records.
Interprets and implements quality policies, manages quality systems and assists in facilitating regulatory compliance inspections.
Communicates company goals, safety practices, and deadlines to team. Motivates team members, provides guidance and leadership, assesses performance and help with development of direct reports.
Responsible for hiring and training, and to keep management updated on team performance.
Communicates concerns and policies among management and team members
Ability to identify and resolve relatively complex problems through good planning and decision making utilizing functional and technical skills.
Accomplishes results through direct reports who exercise significant latitude and independence in their assignments.
Provides guidance to subordinates based on organizational goals and company policy.
Work is reviewed in terms of meeting the organizations objectives and schedules.
Interprets, executes, and recommends modifications to site and organizational policies.
Directly participates in establishing and administering many centralized functional projects.
Ensures that projects are completed on schedule and within budget.
Establishes operating policies and procedures that affect subordinate organizational units.
Excellent verbal and written communication skills.
Ability to make informed decisions. Incorporate risk management into planning and decision-making.
Ability to manage conflict and stand alone on certain issues.
Ability to provide constructive feedback to staff.
Responsible for staff supervision and development including scheduling, recruiting and performance management.
Ability to develop staff through feedback and coaching and set mid and short-term priorities.
Builds and motivates teams.
Able to manage budget and contract resources.
5+ years experience working in a GMP environment within quality and validation
Experience with OSHA regulations preferred
Strong organizational skills and detail oriented
Strong technical writing skills
Ability to work independently to meet deadlines
Previous internal auditing responsibilities preferred
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