We are currently looking to fill an Associate Director, QA Validation (Drug Product) position. This position leads the department responsible for Drug Product Qualification/Validation including but not limited to qualification of equipment, utilities, automation, shipping, and validation of cleaning, sterilization, decontamination, and aseptic process simulation. This position will serve as validation site lead for the fill/finish site and will participate in regulatory inspections/interactions.

In this role, a typical day might include the following:

• Designs and develops policies related to validation and ensures that they are effectively coordinated and align with regulatory requirements

• Responsible for all aspects of QA Validation including review and approval of the following types of documents, relating to area functions:

  • change controls

  • SOPs

  • Policies

  • validation protocols and summary reports

  • validation master plans

  • investigation

• Interviews, hires, orients, and trains incoming team members

• Leads Validation Department team by developing validation work plans, establishing objectives, and assigning tasks

• Develops validation budget, contracts, and schedules

• Measure and organize work as a means to influence collaborators and provide proactive solutions

• Presents/defends validation data to FDA and other regulatory agencies

• Ensures that validation status is maintained for equipment and systems used in commercial and clinical manufacturing

• Organizes QA resources assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management

• Plays a proactive role in developing and applying innovative approaches and processes to validation strategies

• Regularly interacts with cross-functional senior managers and executives to build a broad-based validation program

• Applies complete functional knowledge and awareness of company goals and objectives

• Counsels employees about work performance; conducts hiring and discharge interviews

This role might be for you if you:

• Have strong leadership and project management skills

• Are experienced in biopharma manufacturing validation principals

• Thrive in a quality focused environment

• Are able to mentor and encourage others

• Possess a positive, proactive approach to drive projects/tasks to completion

To be considered for this role you must hold a BA/BS degree in Engineering, Chemistry, or Life Sciences preferred with 10 years of relevant experience in pharmaceutical or biopharmaceutical facilities and manufacturing. At least 5 years experience specifically in a validation/quality assurance function and managerial experience required. Equivalent combination of education and experience may be considered.