Quality Drug Product Design Lead

About the role

The Quality Design Lead Associate Director provides strategic quality leadership for the design and delivery of Fastnet, a non-sterile, high-potent, small molecule spray drying and drug product manufacturing facility at our company in Elkton. This role embeds quality requirements from early project design through construction, qualification, and start-up readiness, helping ensure the facility meets global regulatory expectations, our company's standards, and future operational needs.

Responsibilities

• Lead quality input into the design of the Fastnet non-sterile, high-potent small molecule spray drying and drug product manufacturing facility.
• Embed quality expectations in project deliverables from concept through start-up.
• Review user requirements, design specifications, and related technical documentation for quality impact.
• Support quality risk assessments for facility systems, equipment, utilities, and process flows.
• Ensure design decisions enable contamination control, high-potent product handling, effective material and personnel flow, and operational robustness.
• Provide quality oversight for commissioning, qualification, and start-up readiness activities.
• Partner closely with engineering, operations, validation, EHS, supply chain, project management, technical operations, and quality assurance teams.
• Ensure facility design supports compliance with our company's standards and applicable FDA, EMA, ICH regulatory requirements.
• Support inspection readiness and the development of complete, accurate, and traceable documentation.
• Contribute to a smooth transition from project execution to routine manufacturing operations.
• Promote and sustain a strong quality culture across the project team and future site organization.

Requirements

• Strong background in pharmaceutical quality assurance, quality engineering, or technical operations, with 5–10 years’ experience.
• Experience in spray drying and/or drug product manufacturing, ideally within non-sterile, high-potent small molecule operations.
• Experience supporting facility design, capital projects, qualification, or site start-up activities.
• Expert knowledge of cGMP requirements and global pharmaceutical regulations.
• Strong understanding of contamination control principles, high-potent material handling, facility segregation and flow design.
• Experience with quality risk management, root-cause analysis, and scientific problem-solving.
• Proven ability to work effectively in a matrixed environment.
• Ability to influence, align, and guide stakeholders without direct authority.
• Strong collaboration skills across internal functions and external partners.
• Excellent written and verbal communication skills.
• Strong technical documentation and review capabilities.
• Able to manage multiple priorities in a dynamic project environment.

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline is required.
• An advanced degree is an advantage.