Associate Director

Position Summary

We are looking for an exceptional leader to oversee the Validation Group. The successful candidate will be responsible for developing and implementing the validation strategy and will lead the Commissioning, Qualification and Validation activities to ensure facilities, utilities, and equipment are qualified based on intended use.

Duties & Responsibilities

• Develop the validation strategy for the site and maintain the Validation Master Plan.
• Implement validation policies and related procedures based on regulations and industry standards.
• Provide oversight in the authoring and review of SOPs, protocols, reports and Validation Master Plans for cGMP equipment, utilities, cleaning, analytical methods and instruments.
• Implement and manage cleaning & process validation programs. Plan validation efforts using a risk-based approach.
• Lead Change Control activities and support Tech Transfers to ensure validation activities are identified to support new and existing products.
• Mentor, coach, train and evaluate a team of validation engineers.
• Train end users on validation policies and requirements to support cGMPs.
• Effectively interact and collaborate with cross-functional departments and vendors to drive validation deliverables.
• Serve as subject matter expert in all aspects of validation.
• Establish and maintain continuous improvement projects.
• Participate in regulatory inspections (e.g. FDA, DEA) as a Subject Matter Expert (SME).
• Demonstrates strong leadership, motivation, teambuilding, communication, and advanced coaching skills that instill a strong sense of mission in a team environment across all levels of organization.
• Implement and maintain Data Integrity Controls to ensure data is protected throughout the data lifecycle. Maintain Part 11 / Annex 11 compliance.
• Forecasts and adheres to departmental budget, and responsibly manages resources.
• Implement a culture of continuous improvement and ensure the adoption of best practices.
• Ensure safety is integral to all activities.

Required Qualifications

• A minimum of a bachelors degree is required. An advanced degree, such as an MBA, is desired.
• 10+ years progressive experience in manufacturing, operations management, or quality role at a pharmaceutical manufacturing / distribution facility
• 5+ years of subject matter expertise with validation execution
• 2+ years of experience as a primary SME with regulatory inspections
• Extensive experience working in sterile manufacturing, cleanroom, and cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
• Experience with process validation, cleaning validation and aseptic process simulations.
• Ability to manage diverse teams to execute on the floor activities such as SAT, IQ/OQ/PQ, and Engineering batches.
• Subject matter expertise with Data Integrity.
• Excellent oral and written communication skills, including presentations.
• Ability to explain complex technical issues to key stakeholders and regulatory agencies.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment.

Preferred Qualifications

• SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Experience with continued process verification.
• Demonstrated management and delivery of large capital projects.
• Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired.
• Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.