Quality Drug Substance Design Lead

MSD•Elkton, VA

1d•$142,400 - $224,100•Hybrid

About The Position

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence. At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth. Job Requisition: Quality Design Lead, Drug Substance Manufacturing (Associate Director) Purpose The Quality Design Lead Associate Director provides strategic quality leadership for the design and delivery of Fastnet, a non-sterile, high-potent, small molecule drug substance 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. The Quality Design Lead partners with internal and external stakeholders to shape facility design decisions that influence GMP compliance, contamination control, high-potent material handling, material and personnel flow, utility systems, equipment selection, commissioning, and qualification. This position is based in our company in Elkton, Virginia, USA and requires 20–30% travel during the first two years to support project design, vendor engagement, site visits, and stakeholder alignment. The role will then transition to an on-site role with the Elkton site Quality team, with approximately 10% travel.

Requirements

Strong background in pharmaceutical quality assurance, quality engineering, or technical operations, with 5–10 years’ experience.
Experience in drug substance 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.
Ability to manage multiple priorities in a dynamic project environment.
Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline is required.

Nice To Haves

An advanced degree is an advantage.

Responsibilities

Lead quality input into the design of the Fastnet non-sterile, high-potent small molecule drug substance 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.
Support change control, deviation assessment, and CAPA development throughout the project lifecycle.
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.
Support successful filing and inspection outcomes by responding to questions, supporting health authority inspections and writing observation responses as needed.
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.