Associate Director, Quality - Drug Product Design Lead
Merck & Co.
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Benefits offered by this job
Job summary
Merck & Co., Inc. in Elkton, VA is seeking a Quality Design Lead Associate Director to guide the design and delivery of a high-potent small molecule spray drying facility. You will embed quality from concept to start-up, ensuring GMP compliance and robust processes.
The role partners with engineering, operations, validation, and QA to optimize design decisions, manage risk, and support inspections, with 10-20% travel in the initial years. Onsite role reporting to the Elkton site Quality team.
Qualifications
- 5-10 years of experience in pharmaceutical quality assurance, quality engineering, or technical operations.
- Experience in spray drying and/or drug product manufacturing, ideally non-sterile, high-potent small molecules.
- 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, high-potent material handling, and flow design.
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, and efficient material and personnel flow.
- Provide quality oversight for commissioning, qualification, and start-up readiness activities.
- Support change control, deviation assessment, and CAPA development throughout the project lifecycle.
- Partner with engineering, operations, validation, EHS, supply chain, project management, technical operations, and QA teams.
- Ensure facility design complies with FDA/EMA/ICH regulations and company standards.
- Support inspection readiness and documentation development for health authority interactions.
- Contribute to smooth transition from project execution to routine manufacturing operations.
- Promote a strong quality culture across project team and site organization.
Skills
Education
Job description
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. -
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.
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 10-20% travel during the first two years to support project design, vendor engagement, site visits, and stakeholder alignment. The role is an onsite role and will report to the Elkton site Quality team.
- 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 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.
- 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.
- Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline is required.
- An advanced degree is an advantage.
- Aseptic Processing
- Aseptic Processing
- Audit Management
- CAPA Management
- cGMP Training
- Chemical Engineering
- Chemistry
- Communication Sciences
- Customer-Focused
- Detail-Oriented
- Driving Continuous Improvement
- Engineering Document Management
- Ethical Standards
- Facility Design
- Good Manufacturing Practices (GMP)
- Inspection Readiness
- Manufacturing Processes
- Materials Handling
- Medicinal Chemistry
- Multidisciplinary Teamwork
- Pharmaceutical Regulatory Compliance
- Pharmaceutics
- Quality Control Documentation
- Quality Management Systems (QMS)
- Quality Metrics
- + 9 more
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
USA - Virginia - Elkton
The salary range for the primary location of this role is: $129,000.00 - $203,100.00
The range reflects the Company’s reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
- Medical
- Dental
- Vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation: Domestic/International
VISA Sponsorship: No
Travel Requirements: 25%
Flexible Work Arrangements: Not Applicable
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): na
Job Posting End Date: 11/26/2026
Requisition ID: R426003
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