Associate Director Validation – Biopharma

Associate Director Validation – Biopharma

Requirements

• Bachelors or Master’s degree or University Degree or equivalent in Engineering or equivalent combination of education and or experience preferred.
• 5+ years of experience in management with at least 4 direct reports within a cGMP production facility preferred.
• 10+ years of equivalent experience in validation and or engineering in a pharmaceutical and/or Biologics area required.
• Demonstrated strong management and leadership skills in implementing program/organization strategies.
• Experience with leading and setting policy for cleaning validation; preferably in API and or Biologics.
• Experience with defending a validation program with Boards of Health.
• Independent problem solving and the ability to drive a team to support an ongoing cGMP Operation.
• Experience working with cross-functional groups and leading projects through a matrix of resources to complete.

Responsibilities

• Provide leadership in Validation to ensure Nucleic Acid Solutions Division (NASD) sites meet the regulatory expectations for cGMP manufacture of the product and are aligned with industry expectations.
• Set direction and provide leadership in the areas of cleaning validation, equipment qualification, computer systems validation, and all other aspects of the Validation Programs for NASD.
• Set policy and drive results for the cleaning validation program for NASD.
• Manages, approves, and generates validation documentation including protocols, plans, reports, and addenda.
• Management of validation life cycle to ensure ongoing validated state of systems through oversight of the execution of validation studies for cleaning and equipment qualification as required.
• Responsible for the Master Validation Plan (MVP) and all related documentation.
• Managerial responsibilities include the development of reports and team through mentoring and training with the objective to have a cross-functional group that works well in a team environment.
• Scheduling, advising activities, budgeting, and hiring for the department.
• Set strategic and technical goals for the validation team to provide continuous improvement in the areas of cleaning validation, equipment qualification, and computer validation driving policy to align with regulatory and industry expectations.
• Serves as a liaison and cross-functional lead with Quality Assurance to provide an overall compliant facility with the highest level of service.
• Provide direction and set goals to ensure compliance with the Quality Management System for Validation ensuring a state of inspection readiness.
• Serve as the lead for Validation during client audits and regulatory inspections.
• Act as a delegate for AVP of Engineering and Facilities and other Validation Managers in aspects of Validation.

Preferred Qualifications

• Experience in management with at least 4 direct reports within a cGMP production facility preferred.
• Experience with leading and setting policy for cleaning validation; preferably in API and or Biologics.