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Associate Director Tech Services

Req #: 180006QN_en
Location: Marion, NC US
Job Category: Regulatory Affairs
Date Posted: 3/26/2018 5:08:54 PM
Baxter International

Description

 Job Description

  • Coordinate with Human Resources recruitment, training and organizational programs to establish and maintain the necessary skill base.
  • Lead and develop a team of technical experts responsible for validation and maintenance of a wide variety of equipment and processes.
  • Identify and manage, directly and with oversight, manufacturing process improvements that optimize compliance, quality, service and cost. Develop and manage the site validation master plan covering manufacturing process, equipment, room and equipment cleaning.
  • Work with the Site Manager and the QMR to establish processes that deliver efficiency and consistency. Ensure business continuity is maintained. Ensure budget and project timelines are met for all validation activities.
  • Prepare technical documentation supporting change control and regulatory submissions. Provide routine process trending support to identify critical process parameter trends and respond accordingly. Utilize and promote Lean manufacturing methodology to work flows.
  • Participate as requested in major investigation/reliability situations. Technically manage suppliers where necessary.
  • Participate as needed in developing network alignment strategies.
  • Ensure programs are designed to achieve first time approvals from the FDA, other regulatory agencies, PAI and general cGMP.
  • Manage the technical interfaces with the FDA.
  • Maintain master project activity timelines and progress charts. Prepare and report routinely key quality indicators and other critical activities. Facilitate site visits, training requirements and technical input. Communicate and resolve issues as needed.
  • Sustain a clean and safe work area using 6S principles
  • Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Knowledge, Skill and Abilities
  • Must have a broad base of experience in manufacturing processes and equipment, a solid understanding of cGMP’s and validation processes, process automation and control. Knowledge of current industry validation strategies. Knowledge of current industry data integrity strategy. Understanding and commitment to Lean/Six sigma strategies. 
  • Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
  • Must have basic English written and oral communication skills adequate to communicate with other team members.

 

Qualifications

 

Required Education and Experience
BS/BA in Science or Engineering. PhD a plus.
10 or more years of progressively responsible experience in the pharmaceutical industry. Prior experience supervising, leading and directing groups with diverse technology and business backgrounds. Experience with process remediation a plus.


Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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