Mgr Validation

Cleveland, MS

Req ID 51406BR

Business Title
Mgr, Validation

Business
Global Quality

Sub-Business
Medical Products Support

Country
US

State/Province
Mississippi

Location of Position
Cleveland, MS

Shift_
1st

Job Description

•This position is responsible for all or multiple segments of the validation function at a location. Responsible for managing, developing and implementing validation processes to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements. Position may focus on equipment, process or control system validation or a combination there of. •Manage the activities of a section or department in the Quality organization with responsibility for results in terms of product quality, performance and safety. •Incumbent will schedule, plan and manage validation projects including: facility/system/process improvements, modifications and additions; computer-based systems and software. •Responsibilities also include oversight for the development, completion, logging and archiving of documentation on protocols. •Implements the quality systems procedures and manages compliance in a section or department. •Understands and assures conformance to regulations in a section or department. Interfaces with regulators during regulatory inspections. •Responsibilities also include directing or participating in: performing technical failure analysis of processes/product not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce product/process variability. •Applies statistical analysis and design of experimental approaches to process development activities. •Develops and administers budgets, schedules and performance requirements. Coordinates activities as well as providing day to day guidance to the Validation staff. Acts as advisor to subordinates to meet schedules and/or resolve technical problems. •Interacts frequently with operations and functional peer group managers. •Manages the coaching, training and development of subordinates.

Job Requirements

•Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel. Also must be able to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk •Ability to communicate effectively at all levels in verbal and written form, including technical/business writing. •Proficient in Microsoft Word and Excel, computer software. •Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines. •Thorough knowledge of applicable procedures, specifications, regulations and standards. •Ability to manage/supervise/lead a team of employees. •Good project management skills. •Minimum of a BS in science or engineering. 4+ years experience in Quality, Manufacturing, Engineering with experience in validation within a pharmaceutical, biotech or related industry. Project management experience required.

Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.