New · posted Nov 12
Merck · Pharmaceuticals
Associate Director, Quality - Drug Product Design Lead
- Elkton, VA
- On-site
- Full-time
- Director
The role
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.
What you need
Education
- Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline is required.
- An advanced degree is an advantage.
Required Skills
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}
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 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.
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.
Travel Requirements
25%
Pay and benefits
$129,000 – $203,000 a year
Employer providedAdditional location(s) Compensation Information
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
Medical, dental, vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick and compassionate days
Annual bonus and long-term incentive
Where you'll work
Elkton, VAOn-siteOpen in Maps (opens in a new tab)
More jobs in Elkton, VAWorking conditions
1st - Day
Hazardous Material(s)
na
Employee Status
Regular
Relocation
Domestic/International
VISA Sponsorship
No
Flexible Work Arrangements
Not Applicable
Job Posting End Date
11/26/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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:
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
The primary location for this posting is:
USA - Virginia - Elkton
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$129,000.00 - $203,100.00
This 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.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): 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.
Search Firm Representatives Please Read Carefully
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.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% below the US median for Design Quality & Assurance roles at this level.
This roleEmployer provided
Director roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $129,000 | — | $203,000 |
| All US (middle half) | $183,500 | $209,000 | $211,000 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 77 open Design Quality & Assurance roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- GMP and compliance6
- Documentation and SOPs6
- Validation and qualification5
- Quality systems and risk4
- Investigations and CAPA2
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination products
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q12(official source, opens in a new tab)Lifecycle management of post-approval chemistry, manufacturing and controls changes
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
Company hiring pulse
Merck on Regulatory Jobs
- 41
- Open roles
- 41
- Distinct roles
- 8
- Locations
By discipline
- Clinical26 63%
- Quality8 20%
- Regulatory7 17%
By level
- Director30 73%
- Senior & Principal7 17%
- Associate & Specialist3 7%
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Associate Director, Quality - Drug Product Design Lead at Merck
Applications close November 26. $129K–$203K a year, employer provided.