Associate Director, Quality - Drug Product Design Lead
Merck
Summary
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 in Elkton, Virginia. This role embeds quality requirements from early project design through construction, qualification, and start-up readiness, helping ensure the facility meets global regulatory expectations, company standards, and future operational needs.
Job description
Principal Accountabilities
- 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.
- 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 company 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.
Knowledge, Skills, and Abilities
- 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.
- Ability to manage multiple priorities in a dynamic project environment.
Education
Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline is required. An advanced degree is an advantage.
Requirements
- 5–10 years' experience in pharmaceutical quality assurance, quality engineering, or technical operations
- 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
- Ability to manage multiple priorities in a dynamic project environment
- Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.