Director Quality Validation

The Director Quality Validation ensures Validation activities for product development, process improvement, and commercial manufacturing. Ensures system and process changes are properly documented and qualified as required. Ensures documentation issuance and retention is completed per site and regulatory requirements. Ensures accountability, transparency, and effective communication cross-functionally and within validation team while ensuring information is timely, clear and accurate. Coaching and developing will foster team ownership that ensures compliance with all policies, procedures, and regulations. In addition, must supply the highest level of both internal and external customer service and measure and communicate the team's progress against individual, team and site goals and Key Performance Indicators (KPI's).

Work Schedule: Monday - Friday 8am - 5pm

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOPs.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Ensure the validated state of the Noblesville facility.
• Develops and establishes the site validation plan to ensure compliance with health authority requirements. Leads a team that schedules and performs validation activities (IQ, OQ, PV, PQ) for new and existing equipment, cleaning, processes, systems, methods, facilities and utilities for the site.
• Develops Key Performance Indicators (KPI's) for area and reports updates. Develops action plans when required.
• Approves validation documentation such as but not limited to protocols, deviations, and summary reports, as required.
• Ensures area has appropriate procedures and documentation which is current and maintained for tasks. Ensures personnel are properly trained.
• Review and approved Change Control, CAPA and other related documents, as required.
• Maintain current knowledge of US and International regulations regarding validation and cGMPs and proactively champion validation initiatives to meet same.
• Lead and own all Computer System Validation and Data Integrity activities at the site.
  
  

• Bachelor Degree in Engineering, or related life sciences degree required.
• Twelve or more years of relevant Validation experience, with three or more years of experience in a leadership role required.
• Working knowledge of global cGMPs to comply with US and international regulatory agencies and finished pharmaceutical manufacturing requirements.
• Knowledge with at least two of the following: lyophilizers, autoclaves, VHP, isolators, computer systems, cleaning, process, automated fillers, stopper processors, CIP/SIP, depyrogenation ovens, thermal units, WFI and Clean Steam systems or HVAC.
• Results-oriented, able to make decisions and prioritize work per business needs in a fast-paced environment.
• Strong communication, organization and time management skills are necessary.
• Strong problem solving, decision making, verbal and written communications skills.
• Proficient in use of Microsoft suite of products.
• Frequent partnering with Production, Engineering and QC departments.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
• Domestic and international travel, up to 10%, may be required.